An interventional study of IMPRO - Cross-Sectoral Care Model for Coronary Diagnostics in Coronary Artery Disease (CAD), sponsored by Philipps University Marburg. Recruiting at 39 sites in Germany. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2026-04-07.
Sponsored by Philipps University Marburg · Not applicable, Interventional, and Diagnostic
In Germany, coronary CT offers an accurate and less burdensome alternative to cardiac catheterisation for evaluating suspected coronary artery disease, but it is still underused. The IMPRO stepped-wedge trial tests a new, nationwide care model (NVF) in 16 regions to improve guideline-based intersectoral implementation of coronary CT and assess its impact on cardiovascular outcomes and healthcare costs. If effective, the model of care (NVF) could be adopted across Germany to enhance care quality while reducing unnecessary procedures and expenses.
In Germany, more than 700,000 patients with chest pain undergo cardiac catheterisation each year. The most common reason is suspected coronary artery disease-the leading cause of death worldwide. Proportionally, more cardiac catheterizations are performed in Germany than in any other country. Coronary computed tomography (coronary CT) is available as an alternative diagnostic method to cardiac catheterization. The advantages of coronary CT include a lower complication rate, greater accuracy in detecting deposits in the coronary arteries, reduced burden for patients, and less procedural effort.
The aim of the partners in the IMPRO project is to optimize the implementation of coronary CT in routine clinical care following the resolution of the Federal Joint Committee on January 18, 2024, while at the same time avoiding overuse. For this purpose, a new model of care will be tested in 16 different regions across 12 federal states in Germany. This model is intended to improve primary and cross-sectoral care for patients with suspected coronary artery disease. The primary goal of the nationwide study is to determine whether the new model of care helps reduce cardiovascular events, such as heart attacks and strokes, in patients with suspected coronary artery disease. The researchers will also analyze how patients respond to this type of treatment and whether it leads to cost savings. The project is funded for 39 months with a total of approximately 9.3 million euros.
If successful, the new model of care could be implemented nationwide to improve the treatment of patients with suspected coronary artery disease and to avoid unnecessary costs for the healthcare system.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 3,369 is above the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Usual diagnostic and treatment procedures for suspected coronary artery disease according to national guideline (NVL KHK 2024), without structured cross-sectoral coordination or quality feedback.
Participants in this arm will receive the IMPRO cross-sectoral care model (NVF) for patients presenting with stable chest pain and suspected coronary artery disease (CAD). The program integrates general practitioners and certified cardiac CT centres to improve diagnostic indication, shared decision-making, and reporting quality.
Behavioral: IMPRO - Cross-Sectoral Care Model for Coronary Diagnostics
The intervention consists of structural and procedural components designed to improve cross-sectoral coordination in the diagnostic work-up of patients with suspected coronary artery disease (CAD). It builds upon the 2024 National Disease Management Guideline (NVL KHK 2024) and comprises three main components: (1) evidence-based initial assessment and indication for imaging diagnostics, (2) shared decision-making between primary care physicians, radiologists, and patients, and (3) quality-assured CT imaging and structured reporting in certified centres. Participating sites receive structured training, feedback, and centralized quality monitoring.
Major Adverse Cardiovascular Events (MACE)
Composite endpoint: Major Adverse Cardiovascular Events (MACE) including cardiovascular death, myocardial infarction, stroke, and procedure-related complications from diagnostic testing and subsequent management/therapy in the two randomization groups. Procedure-related complications (major and minor) are defined in the subsequent outcome measure and include events occurring during or within 48 hours after CT or ICA or related tests or revascularization procedures.
Time frame: From enrolment to 12 months for primary MACE analysis in the G-BA-funded IMPRO trial; extended follow-up to 5 years for MACE (cardiovascular death, myocardial infarction, stroke) excluding procedure-related complications; data at 3, 12 months and 5 years
Prospective Primary Safety Endpoint: Procedure-related Complications
Rate of procedure-related complications by diagnostic imaging modality and by interventional/surgical treatments (PCI, CABG). Includes major and minor complications. Major complications: events occurring during or within 48 hours after CT or ICA or related tests or revascularization procedures, including death, nonfatal myocardial infarction, nonfatal stroke, complications prolonging hospitalization ≥24 hours, coronary/aortic dissection, cardiogenic shock, cardiac tamponade, retroperitoneal bleeding, cardiac arrhythmia (ventricular tachycardia/fibrillation), or cardiac arrest. Minor complications: events occurring during or within 48 hours after CT or ICA or related tests or revascularization procedures not meeting major criteria, including hematoma or secondary bleeding at the puncture site, bradycardia, angina pectoris without myocardial infarction, allergic reaction to contrast media, hypotension requiring treatment, infection, thrombosis, or arteriovenous fistula.
Time frame: 3 months and 12 months
Indication quality
1\) Agreement of the diagnostic decision with the pre-test probability (PTP, below 15%, 15-50%, above 50% criterion) with the National Health Services guidelines for suspected coronary artery disease and the statistical distribution of PTP values across the scale (NVL KHK 2024), measured using the updated DISCHARGE PTP calculator in the two randomisation groups, 2) Agreement of the mean pre-test probability with the prevalence of obstructive coronary artery disease (CAD) defined as at least one at least 50% coronary artery diameter stenosis on coronary computed tomography angiography (CTA) and/or invasive coronary angiography (ICA) in the two randomisation groups.
Time frame: From enrollment to 12 months (with follow-up data collection at baseline, 3 months, 12 months)
Functional test rates
Rate of functional tests performed during the follow-up period (stress electrocardiography (ECG), cardiac stress magnetic resonance imaging (MRI), stress echocardiography, stress myocardial perfusion single-photon emission CT (SPECT), myocardial stress perfusion positron emission tomography (PET)) in the two randomisation groups.
Time frame: From enrollment to 12 months and 5 years (with follow-up data collection at 3 months, 12 months and 5 years)
Revascularization rates
Rate of coronary artery revascularisations (percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG)) performed during the follow-up period in the two randomisation groups.
Time frame: From enrollment to 12 months and 5 years (with follow-up data collection at 3 months, 12 months and 5 years)
Coronary CT angiography (CTA) rates
Rate of coronary CT performed during the follow-up period in the two randomisation groups.
Time frame: From enrollment to 12 months and 5 years (with follow-up data collection at 3 months, 12 months and 5 years)
Invasive coronary angiography (ICA) rates
Rate of ICA procedures performed during the follow-up period in the two randomisation groups.
Time frame: From enrollment to 12 months and 5 years (with follow-up data collection at 3 months, 12 months and 5 years)
Invasive coronary angiography (ICA) results
Rate of diagnostic findings on the ICA procedures performed in the two randomisation groups (obstructive or non-obstructive CAD or no signs of CAD) to assess the yield of ICA defined as the proportion of ICAs performed in both randomisation groups demonstrating obstructive CAD.
Time frame: From enrolment to 12 months and 5 years (with follow-up data collection at 3 months, 12 months and 5 years)
Coronary CT angiography (CTA) results
Rate of diagnostic findings on the CTA procedures performed in the two randomisation groups (obstructive or non-obstructive CAD or no signs of CAD) to assess the yield of CTA defined as the proportion of CTAs performed in both randomisation groups demonstrating obstructive CAD.
Time frame: From enrolment to 12 months and 5 years (with follow-up data collection at 3 months, 12 months and 5 years)
Hospitalization due to chest pain
Rate of hospitalisations due to chest pain during the follow-up period in the two randomisation groups.
Time frame: From enrollment to 12 months and 5 years (with follow-up data collection at 3 months, 12 months and 5 years)
Emergency department visits due to chest pain
Rate of emergency department visits due to chest pain during the follow-up period in the two randomisation groups.
Time frame: From enrollment to 12 months and 5 years (with follow-up data collection at 3 months, 12 months and 5 years)
Assessability of coronary CTs
Proportion of non-diagnostic coronary CTs in the two randomisation groups.
Time frame: From enrollment to 12 months (with follow-up data collection at 3 months, 12 months)
Radiation exposure
Estimated radiation exposure of cardiac imaging tests including coronary CT, ICA, SPECT, and PET in the two randomisation groups in millisieverts (mSv).
Time frame: From enrollment to 12 months and 5 years (with follow-up data collection at 3 months, 12 months and 5 years)
Quality of life questionnaire
EQ-5D-5L: validated questionnaire with five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and 5 levels (no problems, slight problems, moderate problems, severe problems and extreme problems) in the two randomisation groups.
Time frame: From enrollment to 3 months, 12 months and 5 years (with follow-up data collection at baseline 3 months, 12 months and 5 years)
Seattle Angina Questionnaire
SAQ-7 questionnaire (short version): disease-specific health status instrument for coronary artery disease (CAD) with seven items from the physical limitations, angina frequency, and quality of life domains in the two randomisation groups.
Time frame: From enrollment to 3 months, 12 months and 5 years (with follow-up data collection at baseline 3 months, 12 months and 5 years)
Total medical care costs (Ct) from the statutory health insurance perspective
Cumulative healthcare costs that can be mapped from routine health insurance data.
Time frame: 3 months, 6 months
Total medical care costs (Ct) from the perspective of society
Cumulative healthcare costs that can be mapped from primary data
Time frame: 3 months, 12 months, 5 years
Cost-effectiveness ratio (ICER) based on routine data collected by health insurers
ΔCt/ΔMACE: The calculated total costs are compared with MACE (primary endpoint). The results are presented as the incremental cost-effectiveness ratio (ICER). Data sources are routine data and patient survey distributed by the health insurers.
Time frame: 3 months, 6 months
Cost-effectiveness ratio (ICER) based on health care utilisation data
ΔCt/ΔMACE: The calculated total costs are compared with MACE (primary endpoint) in the two randomisation groups. The results are presented as the incremental cost-effectiveness ratio (ICER). Data source is primary health care utilisation data in the two randomisation groups.
Time frame: 3 months, 12 months, 5 years
Cost-utility ratio (ICUR) based on routine data collected by health insurers
ΔCt/ΔQALYs: The calculated total costs are compared with quality of life (secondary endpoint), measured using the standardised and validated EQ-5D-5L. The results are presented as the incremental cost-utility ratio (ICUR). Data sources are routine data and patient survey distributed by health insurers.
Time frame: 3 months and 6 months
Cost-utility ratio (ICUR) based on health care utilisation data
ΔCt/ΔQALYs: The calculated total costs are compared with quality of life (secondary endpoint), measured using the standardised and validated EQ-5D-5L. The results are presented as the incremental cost-utility ratio (ICUR). Data sources are primary data and patient quality of life survey in the two randomisation groups.
Time frame: 3 months, 12 months, 5 years
Comparison of incidental findings on CT
Analysis of prevalence of a) non-coronary cardiac causes of symptoms (such as aortic dissection, valve disease, pericarditis) or b) non-cardiac causes of symptoms (such as thrombus, pulmonary embolism, pleural effusion, pneumonia, hiatal hernia) on CT in the two randomisation groups.
Time frame: 3 months, 12 months, 5 years
Effects of incidental findings on CT
Influence of non-coronary cardiac and non-cardiac findings on MACE, non-cardiac events and Quality of Life (QoL) measured using EQ-5D-5L in the two randomisation groups.
Time frame: 3 months, 12 months, 5 years
Malignant incidental findings
Rate for malignancy in pulmonary nodules seen on CT (reference standard: biopsy results in the two randomisation groups, Positron Emission Tomography (PET) findings, or progression versus no change or regression on follow-up CT).
Time frame: 3 months, 12 months, 5 years
Rate of death from cancer
Rate of death from cancer in both randomisation groups.
Time frame: 5 years
Rates of unnecessary follow-up procedures.
Composite outcome: Rates of unnecessary follow-up procedures such as examinations, biopsies, or surgeries performed based on non-coronary findings on CT in the two randomisation groups.
Time frame: 3 months, 12 months, 5 years
Analysis of coronary CT site versus core lab and interobserver core lab readings
Analysis of interobserver variability (site vs. core lab and interobserver in the core lab) of reading for the presence of coronary stenosis (obstructive CAD) and plaques on CTA (types, characteristics, volumes etc.).
Time frame: 3 months, 12 months
Association between plaque characterisation and quantification by core lab and MACE
Association between plaque characterisation and quantification by core lab and MACE (with and without inclusion of procedure-related complications).
Time frame: 5 years
Image quality of Computed Tomography by core lab read
Image quality of coronary CT by core lab read (manual and automated): comparison of the two randomisation groups. This analysis involves also an analysis of the heart rate during CT and the use of oral and intravenous betablockers before CTA in the two randomisation groups.
Time frame: 3 months, 12 months, 5 years
Noise in Computed Tomography Angiography
Noise in CTA imaging in the two randomisation groups and the factors it depends on, for instance adherence vs. non-adherence to scan protocol.
Time frame: 3 months, 12 months, 5 years
Aortic valve calcification and fibrosis on CT to predict MACE and need for TAVR or SAVR
Quantitative assessment of aortic valve calcification and fibrosis on CT to predict the occurrence of major adverse cardiovascular events (MACE) and the future need for transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR). This outcome includes the following objectives: 1. To automate the measurement of fibrotic and calcified aortic valve characteristics on CT; 2. To assess the concordance between anatomical fibrocalcific aortic valve thickening and functional haemodynamics as measured by echocardiography, and to predict rapid hemodynamic progression; 3. To develop and validate an integrated patient risk score for predicting clinical outcomes.
Time frame: 3 months, 12 months, 5 years
Correlation of a zero-calcium score by CT and MACE
Analysis of prevalence of MACE in correlation to a calcium score (CS) of zero: the prognostic value of a calcium score of zero.
Time frame: 3 months, 12 months, 5 years
Characterisation of plaques
The characterisation of plaques (type and composition) by CT core lab in relation to cardiac risk factors at baseline in all patients who underwent CT.
Time frame: baseline
Influence of statin treatment on plaque development.
Risk factors for and influence of statin treatment on plaque progression or regression in patients who had follow-up cardiac CT done.
Time frame: 3 months, 12 months
Gender differences in MACE, procedural complications, and examination results.
Comparison of MACE, procedural complications, and examination results (rate of coronary artery disease, PCI rate adjusted for CAD prevalence, occurrence of adverse events, stress tests used, patient acceptance) in women and men in the two randomisation groups.
Time frame: 3 months, 12 months, 5 years
Age differences in MACE, procedural complications, and examination results.
Comparison of MACE, procedural complications, and examination results (rate of coronary artery disease, PCI rate adjusted for CAD prevalence, occurrence of adverse events, stress tests used, patient acceptance) in both randomisation groups in patient a) under 65 years, b) between 65 and 75 years and c) over 75 years.
Time frame: 3 months, 12 months, 5 years
Differences in MACE, procedural complications, and examination results in patients living with and without diabetes mellitus.
Comparison of MACE, procedural complications, and examination results (rate of coronary artery disease, PCI rate adjusted for CAD prevalence, occurrence of adverse events, stress tests used, patient acceptance) in patients with and without diabetes mellitus in the two randomisation groups.
Time frame: 3 months, 12 months, 5 years
Differences in MACE, procedural complications, and examination results between patients of different body mass index (BMI) groups.
Comparison of MACE, procedural complications, and examination results (rate of coronary artery disease, PCI rate adjusted for CAD prevalence, occurrence of adverse events, stress tests used, patient acceptance) in patients with BMI a) under 25, b) between 25 and 30 and c) over 30 in the two randomisation groups.
Time frame: 3 months, 12 months, 5 years
Differences in MACE, procedural complications, and examination results between patients with different smoking habits.
Comparison of MACE, procedural complications, and examination results (rate of coronary artery disease, PCI rate adjusted for CAD prevalence, occurrence of adverse events, stress tests used, patient acceptance) in patients with different smoking habits (current smokers, current non-smokers, never-smokers) in the two randomisation groups.
Time frame: 3 months, 12 months, 5 years
Differences in MACE, procedural complications, and examination results between patients with quality of life (QoL) reductions versus patients with no changes in QoL.
Comparison of MACE, procedural complications, and examination results (rate of coronary artery disease, PCI rate adjusted for CAD prevalence, occurrence of adverse events, stress tests used, patient acceptance) in patients with significant QoL reductions versus patients with no changes in QoL in the two randomisation groups.
Time frame: 3 months, 12 months, 5 years
Differences in MACE, procedural complications, and examination results between pre- and post-menopausal women.
Comparison of MACE, procedural complications, and examination results (rate of coronary artery disease, PCI rate adjusted for CAD prevalence, occurrence of adverse events, stress tests used, patient acceptance) in pre- and post-menopausal women in the two randomisation groups.
Time frame: 3 months, 12 months, 5 years
Differences in coronary plaque characteristics determined by Computed Tomography in pre- and post-menopausal women.
Differences of coronary plaque characteristics determined by CT including parameters like coronary plaque assessment, including calcified, mixed and non-calcified plaques, remodelling index, ring-sign, spotty calcification in pre- and post-menopausal women.
Time frame: 3 months, 12 months
Differences of epicardial adipose tissue (EAT) characteristics determined by Computed Tomography between pre- and post-menopausal women and association with MACE.
Differences of epicardial adipose tissue characteristics determined by CT including parameters like EAT volume, EAT density, EAT radiomics (adjusted for coronary calcium score, age and body surface area) and their relation to MACE and CAD.
Time frame: 3 months, 12 months
Prognostic validation of the Marburg Heart Score (MHS)
The MHS is a well validated and established diagnostic clinical prediction rule estimating the clinical probability of coronary heart disease in patients presenting with chest pain in primary care. However, the prognostic value has not been evaluated so far. For this secondary analysis, we will calculate the rate of coronary events (death, lethal and non-lethal myocardial infarctions), stratified by the MHS score values.
Time frame: 3 months and 12 months
Pretest Probability in patients receiving CTA
Comparison of the pretest probability between the two randomisation groups in patients receiving CTA to determine success of the intervention in regard to indication for CTA.
Time frame: 3 months and 12 months
Updated DISCHARGE calculator
Recalibration of the DISCHARGE calculator based on the results of the trial. Calibration will be done nationwide across Germany and regionally. Both versions will be compared.
Time frame: 3 months, 12 months, 5 years
Prognostic validation of the DISCHARGE Calculator.
The DISCHARGE Calculator is based on the well validated COME-CCT Calculator and was calibrated on the DISCHARGE trial data. However, the prognostic value has not been evaluated so far. For this secondary analysis, we will calculate the rate of MACE and any subset within MACE, stratified by the DISCHARGE Calculator.
Time frame: 3 months, 12 months, 5 years
Bayesian analysis - Differences in rate of MACE and additional secondary outcomes in the two randomization groups.
Bayesian evaluation of the different rates of major adverse cardiovascular events (MACE) and secondary outcomes in the two randomization groups. The primary analysis assesses whether the intervention reduces 12-month MACE compared with standard care in patients with suspected chronic CAD. Secondary outcomes are analysed using Bayesian methods.
Time frame: 12 months
MACE differences between the two randomisation groups depending on if patients were recruited in the primary care setting or in CT centres.
Does recruitment in primary care setting versus in CT centres impact the rate of MACE within the two randomisation groups and between the two randomisation groups?
Time frame: 12 months
Time to Final Diagnosis
Time from first clinical presentation with stable chest pain (recruitment) to documented final diagnostic classification (obstructive CAD, non-obstructive CAD, or no signs of CAD or no need to further investigate as the chest pain is clearly noncardiac) in the two randomisation groups
Time frame: 3 months and 12 months
Documentation of Pre-test Probability
Proportion of patients with documented pre-test probability assessment prior to diagnostic CT and ICA in the two randomisation groups
Time frame: 3 months and 12 months
Documentation of Clinical Decision Rationale
Proportion of patients with documented justification for the selected diagnostic strategy (e.g., CTA-first, functional testing, direct ICA) in the two randomisation groups.
Time frame: 3 months and 12 months
Multistep Diagnostic Pathway Rate
Proportion of patients undergoing more than one sequential non-therapeutic diagnostic tests (e.g., CTA → stress imaging → ICA) in the two randomisation groups.
Time frame: 3 and 12 months
Initiation or Intensification of Statin Therapy
Proportion of patients in whom lipid-lowering therapy is newly initiated or escalated (dose increase or switch to high-intensity statin) following diagnostic evaluation.
Time frame: 3 months, 12 months, and 5 years
No-Show Rate
Proportion of scheduled diagnostic imaging appointments (CTA or ICA) not attended by the patient without prior cancellation.
Time frame: 3 months and 12 months
Structured Reporting
Proportion of structured quantitative CTA reports according to QCI consensus statement and the results of the ISCHEMIA trial (no CAD-RADS) in the two randomisation groups.
Time frame: 3 months and 12 months
Inclusion of Patient-Friendly Summary in Imaging Report
Proportion of CTA reports that include a standardised patient-friendly summary explaining results, cardiovascular risk implications, and recommended next steps in plain language in the two randomisation groups.
Time frame: 3 months and 12 months
Patient acceptance of informed consent, preparation and procedural aspects of the test performed
Patient acceptance of informed consent, preparation, procedural aspects of the tests performed and patient acceptance of the management recommendations.
Time frame: 3 months and 12 months
Gender differences regarding all aspects of medical history
Gender differences regarding all aspects of medical history will be collected at baseline and follow-up. Data will be analysed in regards to occurrence of MACE and MICE in all genders.
Time frame: Baseline, 3 months and 12 months
Geographic Subgroup Analysis of All Study Outcomes by Cluster Region
All primary, secondary, and pre-specified study outcomes will be analysed according to predefined cluster regions within the stepped-wedge design to assess regional heterogeneity of intervention effects in the two randomisation groups.
Time frame: 3 months, 12 months and 5 years
Geographic Subgroup Analysis of All Study Outcomes by Federal State (Bundesland)
All primary, secondary, and pre-specified study outcomes will be analysed across German federal states (Bundesländer) to assess regional heterogeneity of intervention effects in the two randomisation groups.
Time frame: 3 months, 12 months and 5 years
Geographic Subgroup Analysis of All Study Outcomes by Cardinal Region (North, South, East, West)
All primary, secondary, and pre-specified study outcomes will be analysed according to aggregated cardinal regions of Germany (North (Hamburg, Kiel/Lübeck, Göttingen), South (Augsburg, Erlangen, Würzburg/Bad Neustadt, Ulm, Tübingen), East (Rostock/Greifswald, Berlin/Brandenburg, Jena, and Leipzig), and West (Düsseldorf, Wiesbaden/Frankfurt, Marburg/Gießen, Köln) to explore broad geographic variation of intervention effects in the two randomisation groups..
Time frame: 3 months, 12 months and 5 years
Process Evaluation - Context Description
Questionnaire for sociodemographic and characteristics of primary care and CT centres. Interviews regarding contextual factors that shape how the intervention works; and that affect (or may be affected by) implementation, intervention mechanisms and outcomes. Causal mechanisms present within the context which act to sustain the status quo or potentiate effects by comparing the two randomisation groups.
Time frame: Questionnaire at initiation; Interview/Focusgroup-discussion
Process Evaluation - Intervention (TIDieR Checklist)
TIDieR Checklist is used to describe the complex intervention
Time frame: Study beginning (planned intervention); End of study (potentially shaped intervention)
Process Evaluation - Implementation (Delivery)
How is delivery achieved; training, resources, etc. Participation of at least 1 person/clinic; Positive online-evaluation (emotion, readiness to present again in the clinic, grading (as in school grades), open feedback, self-evaluated competency in the two randomisation groups.
Time frame: Ongoing documentation; Online questionnaire after training
Process Evaluation - Implementation/Normalization (Sustainability)
NoMad-survey for long-term implementation (normalisation); Implementation questionnaire and interviews with Elements: Integration in every-day routine, knowledge of guideline, involvement of cardiologists in the two randomisation groups.
Time frame: End of intervention phase
Process Evaluation - Mechanisms of Impact
Multiple provenances of data and acquisition time-points to test mechanisms of impact: Questionnaire on the use of a pre-test probability calculator; Questionnaire on use of decision aids; Questionnaires on structure of radiology reports; Qualitative experiences of all involved person-groups in the two randomisation groups.
Time frame: Ongoing
Time to Imaging
Time from first clinical presentation with stable chest pain (recruitment) to first documented diagnostic imaging procedure.
Time frame: 3 months and 12 months
Quantitative coronary artery plaque quantification using AI assisted software
Development and/or testing of an automated coronary artery plaque quantification tool for total plaque volume, calcified plaque volume, and noncalcified plaque volume with high diagnostic accuracy and predictive value for MACE.
Time frame: 3 months, 12 months, and 5 years
Automated High Risk Plaque Quantification
Development and/or testing of an automated high risk plaque (HRP) quantification tool with high diagnostic accuracy and predictive value for MACE.
Time frame: baseline, 3 and 12 months
Automated cardiac and multi-organ Total Segmentator for imaging biomarker quantification
Development and/or testing of an automated Total Segmentator tool for quantitative imaging biomarker extraction, aiming to achieve high diagnostic accuracy and predictive value for major adverse cardiovascular events (MACE). This includes the development and validation of a dedicated cardiac Total Segmentator for detailed segmentation of cardiac structures, as well as a complementary multi-organ segmentation model to enable integrated assessment of cardiac and extracardiac imaging biomarkers relevant to cardiovascular risk. The approach will evaluate the performance of these models in terms of segmentation accuracy, robustness, and their ability to improve prediction of MACE.
Time frame: baseline, 3 and 12 months
Interobserver variability in quantitative coronary artery plaque analysis
We aim to determine if the elements of the NVF have an impact on interobserver variability in CT in the intervention phase compared to the control phase by comparing the two randomisation groups.
Time frame: baseline, 3 and 12 months
Automated segment-based tool for coronary artery calcium (CAC) quantification
Fully automated quantification of coronary artery calcium on CT on the vessel- and segment level, and its prognostic ability for major adverse cardiovascular events (MACE).
Time frame: baseline, 3 and 12 months
Rate of CABG procedures planned on CT versus planned on ICA
Are there more coronary artery bypass grafting (CABG) procedures being planned on CT (rather than ICA) in the intervention phase compared to the control phase? This will be assessed by the proportion of patients undergoing ICA after CT for planning of CABG.
Time frame: baseline, 3 and 12 months
Plan to share: Yes — Data sharing will be performed through with the GUIDE-IT platform (Guide to Data Sharing of Imaging Trials, www.guideit.org), which will allow access for researcher according to the GUIDE-IT data sharing rules and governance as well as application processes. After completion of the study, pseudonymised data will be made available for scientific reuse. This will comprise clinical data, including clinical endpoints at 3 and 12 months as well as 5 years, and imaging data (cardiac CT scans in DICOM format). Specifically: Demographic data: age category, gender, weight, height. Health data: Clinical data (diagnoses, medical history, physical examinations, vital signs, concomitant medication, laboratory parameters, cardiological parameters: ECG, etc.) Image data: Computed tomography scans Questionnaire data (quality of life (EQ-5-DL), angina (SAQ-7))
Supporting information: Study protocol
Time frame: Data will be shared after completion of the IMPRO study for a maximum period of 30 years.
Access criteria: Access to pseudonymized data will only be granted to those who submit an application to the dissemination committee (members of the consortium leadership of the participating studies). The provided pseudonymized data comprise both clinical data, including clinical endpoints at 3 and 12 months as well as at 5 years, and imaging data (cardiac CT scans in DICOM format). The study proposal must include: The proposed study's overview, rationale, aims and analysis methods, plans for dissemination of results and names of those wishing to access data, and how is the data going to be stored and for how long.
Data sharing details ↗ · www.guideit.org
Started Apr 2026 (actual). Primary completion is estimated for Mar 2028, 23 months after the start.
Of 753 non-industry interventional studies with no phase under Coronary Artery Disease, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 53. This study's planned 23 months is below that.
Counting every sponsor, half of 930 studies reached it within 30 months; a quarter within 15 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
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