An interventional study of Stress Dynamic MPI SPECT and Stress Static MPI SPECT in Coronary Artery Disease, Coronary Computed Tomography Angiography and SPECT, sponsored by Semmelweis University. Recruiting at 1 site in Hungary. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-25.
Sponsored by Semmelweis University · Not applicable, Interventional, and Diagnostic
This prospective study aims to compare functional abnormalities detected using myocardial perfusion SPECT imaging (MPI SPECT) with the extent and severity of anatomical findings on coronary computed tomography angiography (coronary CTA). Additionally, the investigators aim to enhance the diagnostic value of MPI SPECT by quantifying myocardial blood flow and utilizing myocardial flow reserve calculated from dynamic SPECT images.
50 patients with suspected coronary artery disease are anticipated to be enrolled. Pharmacological stress and rest-phase dynamic and static MPI SPECT following an additional coronary CTA scan are to be performed. The obtained multimodality imaging data (functional and anatomical parameters) are planned to be compared and subjected to statistical analysis. The results of this study are expected to improve risk assessment for patients with moderate cardiovascular risk and enhance the diagnostic performance of MPI SPECT.
Diagnostic management of patients with moderate clinical likelihood of obstructive coronary artery disease (CAD) remains challenging. Myocardial perfusion SPECT imaging (MPI SPECT) is a widely available and cost-effective modality that provides functional information on segmental perfusion defects. However, conventional static MPI SPECT has moderate diagnostic performance in identifying subclinical coronary atherosclerosis.
The novel multi-pinhole (MPH) collimator technology with a three-detector SPECT camera (AnyScan® TRIO SPECT/CT, Mediso Ltd., Hungary) enables temporal and spatial resolution, absolute quantification of stress and rest myocardial blood flow (sMBF and rMBF), and calculated myocardial flow reserve (MFR), overcoming the difficulties of semi-quantitative evaluation.
This study aims to investigate the association between quantitative MFR, semi-quantitative functional parameters of dynamic, static MPI SPECT, and coronary CTA-based plaque metrics. Flow parameters of myocardial wall segments will be corresponded to the appropriate coronary artery based on the CT-assessed anatomy. Furthermore, the investigators aim to build statistical models representative of clinical scenarios to test the diagnostic accuracy of the MPH collimator.
In this prospective study, 50 patients with moderate cardiovascular pre-test probability (PTP) referred to either coronary CTA or MPI SPECT are anticipated to be enrolled. Cardiovascular PTP is estimated according to the CAD consortium based on age, sex, type of chest pain, and cardiovascular risk factors. Patients with a history of coronary artery bypass graft implantation, left or right bundle branch block, and atrial fibrillation will be excluded. Participants will be subjected (1) to dynamic and (2) static MPI SPECT (pharmacological stress and rest) and (3) to coronary CTA within 30 days. Patients undergoing pharmacological stress (dipyridamole or adenosine) dynamic MPI SPECT, which will be performed with AnyScan® TRIO SPECT/CT (Mediso Ltd.). Imaging will be started at the time of the radiopharmaceutical administration both in stress and rest, captured for 15 minutes in list mode. BMI-standardized doses of 99m-Tc will be used, with a same-day acquisition protocol, resulting in a three-fold increase for the rest phase compared to stress. Following each phase of dynamic acquisition in 30-60 minutes, an ECG-gated static MPI SPECT will be performed using a conventional LEHR collimator.
Data, such as sMBF, rMBF, MFR, summed stress score (SSS), summed rest score (SRS), summed difference score (SDS), as well as visually evaluated perfusion defect severity and extent will be determined from MPI SPECT. Within 30 days of MPI SPECT, coronary CTA with Calcium Score assessment will also be performed using a photon-counting detector CT (NAEOTON Alpha, Siemens Healthineers, Germany). Coronary CTA will be analyzed as follows: coronary artery calcium score (CACS), the severity of luminal stenosis, total plaque volume, quantitative plaque composition, and CT-derived fractional flow reserve (FFR). The following additional anamnestic covariants will be used: age, sex, and cardiovascular risk factors such as type of chest pain, diabetes mellitus, hypertension, smoking, obesity, and dyslipidemia.
The investigators hypothesized that dynamic MPI SPECT may prove to be superior to semi-quantitative static MPI SPECT in detecting CAD. Furthermore, MFR data combined with CACS may improve the diagnostic accuracy of MPI SPECT and guide the selection of patients for invasive coronary angiography.
MPI SPECT and coronary CTA data will be analyzed on-site at Semmelweis University, Hungary. The results will be available after the completion of patient enrollment.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 50 is below the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Semmelweis University is the lead sponsor of 140 studies on the registry; 56 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
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.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergo dynamic and static MPI SPECT and cardiac CT within 30-days.
Diagnostic Test: Stress Dynamic MPI SPECT · Diagnostic Test: Stress Static MPI SPECT · Diagnostic Test: Rest Dynamic MPI SPECT · Diagnostic Test: Rest Static MPI SPECT · Diagnostic Test: Cardiac CT
BMI standardized radiopharmaceutical injection in pharmacological stress (dipyridamole or adenosine) is performed under the SPECT camera to record the temporal distribution of the activity. A one-day protocol and multi-pinhole collimator are used.
30-60 minutes after stress dynamic SPECT imaging is performed, an ECG-gated static SPECT MPI is conducted with a conventional LEHR collimator.
3 hours after the stress phase, the rest phase is also recorded. A radiopharmaceutical injection with a three-fold dose at rest is performed under the SPECT camera to record the temporal distribution of the activity. A one-day protocol and multi-pinhole collimator are used.
30-60 minutes after rest, dynamic SPECT imaging is performed, and an ECG-gated static SPECT MPI is conducted with a conventional LEHR collimator.
Within 30 days of MPI SPECT imaging, a cardiac CT is performed for every patient, including a native calcium-scoring scan and a coronary CT angiography as a reference standard. A photon-counting detector CT is used.
The association between Myocardial Flow Reserve (MFR) and total non-calcified plaque volume as assessed by coronary CTA.
Predictive value of MFR on vessel and participant level, expressed as the ratio of Stress/Rest Myocardial Blood Flow (sMBF/rMBF). The total non-calcified plaque volume will be measured by PCD-CT.
Time frame: As soon as all required data is available but not later than study completion, an avarage of one year.
Predictive Value of Myocardial Flow Reserve (MFR) to CT-derived Fractional Flow Reserve (FFR-CT)
The predictive value of MFR on vessel and participant levels is expressed as the ratio of stress/rest myocardial blood flow (sMBF/rMBF) to FFR-CT of 0.8 or less in any coronary artery. FFR-CT values are defined as follows: greater than 0.8 is normal, 0.76-0.8 is borderline, and 0.75 or less is abnormal.
Time frame: As soon as all required data is available but not later than study completion, an avarage of one year.
Predictive Value of stress Myocardial Blood Flow (sMBF) to lumen stenosis extent on coronary CTA
The predictive value of sMBF on vessel and participant level, derived from dynamic MPI SPECT, expressed in unit of ml/min/g to luminal stenosis extent. The severity of luminal stenosis is defined as follows: no stenosis, 1-24% minimal, 25-49% mild, 50-69% moderate, 70-99% severe, occlusion.
Time frame: As soon as all required data is available but not later than study completion, an avarage of one year.
Predictive Value of stress Myocardial Blood Flow (sMBF) to CT-derived Fractional Flow Reserve (FFR-CT)
The predictive value of sMBF on vessel and participant levels, derived from dynamic MPI SPECT, is expressed in a unit of ml/min/g to FFR-CT of 0.8 or less in any coronary artery. FFR-CT values are defined as follows: greater than 0.8 is normal, 0.76-0.8 is borderline, and 0.75 or less is abnormal.
Time frame: As soon as all required data is available but not later than study completion, an avarage of one year.
Correlation of Myocardial Flow Reserve (MFR) and quantitative plaque composition
Correlation of MFR on vessel level, expressed as the ratio of Stress/Rest Myocardial Blood Flow (sMBF/rMBF) and plaque composition. Plaque components are defined based on the following Hounsfield Unit (HU) threshold ranges: Low-attenuation plaque: - 100 to 30 HU; Non-calcified plaque: 30 to 350 HU; Calcified plaque: above 350 HU.
Time frame: As soon as all required data is available but not later than study completion, an avarage of one year.
Predictive Value of Summed Stress Score (SSS) to lumen stenosis extent on coronary CTA.
The predictive value of semi-quantitative SSS derived from static MPI SPECT using a dedicated software on vessel and participant level to lumen stenosis extent. Classification of SSS is as follows: 0-3 normal, 4-8 mildly abnormal, 8-13 moderately abnormal, and above 13 severely abnormal. The severity of luminal stenosis is defined as follows: no stenosis, 1-24% minimal, 25-49% mild, 50-69% moderate, 70-99% severe, occlusion.
Time frame: As soon as all required data is available but not later than study completion, an avarage of one year.
Predictive Value of Summed Stress Score (SSS) to CT-derived Fractional Flow Reserve (FFR-CT)
The predictive value of semi-quantitative SSS derived from static MPI SPECT using a dedicated software on vessel and participant level to FFR-CT of 0.8 or less in any coronary artery. Classification of SSS is as follows: 0-3 normal, 4-8 mildly abnormal, 8-13 moderately abnormal, and above 13 severely abnormal. FFR-CT values are defined as follows: greater than 0.8 is normal, 0.76-0.8 is borderline, and 0.75 or less is abnormal.
Time frame: As soon as all required data is available but not later than study completion, an avarage of one year.
Predictive Value of Summed Difference Score (SDS) to lumen stenosis extent on coronary CTA.
The predictive value of semi-quantitative SDS derived from static MPI SPECT using a dedicated software on vessel and participant level to lumen stenosis extent. of 50% or more in the left main coronary artery or 70% or more in any coronary artery. Classification of SDS is as follows: 0-3 normal, 4-8 mildly abnormal, 8-13 moderately abnormal, and above 13 severely abnormal. The severity of luminal stenosis is defined as follows: no stenosis, 1-24% minimal, 25-49% mild, 50-69% moderate, 70-99% severe, occlusion.
Time frame: As soon as all required data is available but not later than study completion, an avarage of one year.
Predictive Value of Summed Difference Score (SDS) to CT-derived Fractional Flow Reserve (FFR-CT)
The predictive value of semi-quantitative SDS derived from static MPI SPECT using a dedicated software on vessel and participant level to FFR-CT of 0.8 or less in any coronary artery. Classification of SDS is as follows: 0-3 normal, 4-8 mildly abnormal, 8-13 moderately abnormal, and above 13 severely abnormal. FFR-CT values are defined as follows: greater than 0.8 is normal, 0.76-0.8 is borderline, and 0.75 or less is abnormal.
Time frame: As soon as all required data is available but not later than study completion, an avarage of one year.
Comparison of visual assessment of static MPI SPECT to luminal stenosis extent on coronary CTA.
Static MPI SPECT images will be evaluated by a nuclear medicine specialist. Results will be compared to luminal stenosis extent on coronary CTA. The severity of luminal stenosis is defined as follows: no stenosis, 1-24% minimal, 25-49% mild, 50-69% moderate, 70-99% severe, occlusion.
Time frame: As soon as all required data is available but not later than study completion, an avarage of one year.
Comparison of visual assessment of static MPI SPECT to CT-derived Fractional Flow Reserve (FFR-CT)
Static MPI SPECT images will be evaluated by a nuclear medicine specialist. Results will be compared to FFR-CT. FFR-CT values are defined as follows: greater than 0.8 is normal, 0.76-0.8 is borderline, and 0.75 or less is abnormal.
Time frame: As soon as all required data is available but not later than study completion, an avarage of one year.
Predictive Models of Myocardial Flow Reserve (MFR) and Other Covariants to Coronary Artery Disease (CAD) Severity Identified by Coronary CTA
Composite endpoint: model 1: type of chest pain, sex, age model 2: model 1 + static MPI SPECT (SSS, SRS, SDS with the following classification: 0-3 normal, 4-8 mildly abnormal, 8-13 moderately abnormal, and above 13 severely abnormal) model 3: model 2 + MFR (expressed as a sMBF/rMBF ratio) model 4: model 3 + CACS (The following classification is used for CACS: 0, 1-9, 10-99, 100-399, 400-1000, \>1000)
Time frame: As soon as all required data is available but not later than study completion, an avarage of one year.
Predictive Value of Myocardial Flow Reserve (MFR) to stenosis extent on coronary CTA.
Predictive value of MFR on vessel and participant level, expressed as the ratio of Stress/Rest Myocardial Blood Flow (sMBF/rMBF) to luminal stenosis extent. The severity of luminal stenosis is defined as follows: no stenosis, 1-24% minimal, 25-49% mild, 50-69% moderate, 70-99% severe, occlusion.
Time frame: As soon as all required data is available but not later than study completion, an avarage of one year.
Plan to share: Yes — A secure platform will be used to share clinical and imaging data after the results are published.
Time frame: Clinical and imaging data will be available after the results have been published.
Access criteria: Access request needs to be made directly to the PI.
No publications or documents are linked to this record.
Started Mar 2024 (actual). Primary completion is estimated for Aug 2025, 17 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 17 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.
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