An observational study in Acute Coronary Syndrome, Non ST Segment Elevation Acute Coronary Syndrome and Chronic Coronary Syndrome, sponsored by Medical University of Warsaw. Recruiting at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-13.
Sponsored by Medical University of Warsaw · Observational
Fractional flow reserve (FFR) has revolutionized the diagnosis and treatment of coronary artery disease (CAD), and more recently, post percutaneous coronary intervention (post-PCI) FFR has emerged as an independent predictor of cardiovascular events, enabling the identification of cases requiring additional optimization of the implanted stent. Modern technologies allow less invasive alternatives to traditional FFR measurement - angiography-based vessel fractional flow reserve (vFFR) and derivative ΔvFFR, which is calculated by a difference between the post-PCI vFFR and pre-PCI vFFR. In large clinical studies, the good accuracy between vFFR and FFR - measured before and after PCI - has been confirmed. However, insufficient data is available about the value of post-vFFR and ΔvFFR as prognostic values and indicators of patient health.
This is a prospective multicenter register study analyzing the association between the value of ΔvFFR, vFFR after PCI and adverse clinical outcomes, residual angina and quality of life using the validated Seattle Angina Questionnaire (SAQ) and EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L). Patients undergoing PCI for chronic coronary syndromes (CCS), non-ST-segment elevation acute coronary syndromes (NST-ACS) or ST-Segment Elevation Myocardial Infarction (STEMI) will be enrolled in this study.
The primary goal of this prospective multicenter register study is to evaluate the association between the value of vFFR after PCI and adverse clinical outcomes, residual angina and quality of life using the validated Seattle Angina Questionnaire (SAQ) and EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L) at 6 and 24 months following PCI. The primary composite endpoint is defined as a major adverse cardiovascular event (MACE) including all-cause death, target-vessel myocardial infarction (TVMI), and target vessel revascularization (TVR)] at 6, 12 and 24-month follow-ups. Patients undergoing PCI for chronic coronary syndromes (CCS), non-ST-segment elevation acute coronary syndromes (NST-ACS) or or ST-Segment Elevation Myocardial Infarction (STEMI) will be enrolled in this study. The analyses of the primary endpoint will be stratified according to the following subgroups:
The patients' coronary angiograms will be analyzed using a CAAS workstation (Pie Medical Imaging, Maastricht, the Netherlands) enrolled at the Invasive Cardiology Unit of the 1st Department of Cardiology, Medical University of Warsaw (Poland) and other centers in Poland.
1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.
This study's planned enrollment of 2,005 is above the median of 500 across 561 observational studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →Medical University of Warsaw is the lead sponsor of 316 studies on the registry; 87 are open to participants now.
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Patients with percutaneous coronary intervention (PCI) for chronic coronary syndromes (CCS) or acute coronary syndromes (ACS)
Exclusion Criteria:
Assessment of ΔvFFR and vFFR after PCI and adverse clinical outcomes, residual angina and quality of life using the validated Seattle Angina Questionnaire (SAQ) and EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L) in patients with CCS or ACS.
Diagnostic Test: Angiography-based vessel fractional flow reserve (vFFR) calculation
vFFR is calculated from routinely taken angiography images during PCI using a CAAS workstation (Pie Medical Imaging, Maastricht, the Netherlands)
Rate of MACE defined as all-cause death, target-vessel myocardial infarction (TVMI) and target vessel revascularization (TVR).
Time frame: 24 months
Rate of MACE defined as all-cause death, target-vessel myocardial infarction (TVMI) and target vessel revascularization (TVR).
Time frame: 6 months, 12 months
Rate of all-cause death
Time frame: 6 months, 12 months, 24 months
Rate of target-vessel myocardial infarction (TVMI)
Time frame: 6 months, 12 months, 24 months
Rate of target-vessel target vessel revascularization (TVR)
Time frame: 6 months, 12 months, 24 months
Symptoms of angina and quality of life assessed by the score of EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L)
The EQ-5D-5L scale asses the patient's self-rated health in five categories (each category 1-5) - higher values indicate worse performance. Additionally, the patient fulfill vertical visual analog scale from 0 to 100, where higher scores indicate better function.
Time frame: 6 months, 12 months, 24 months
Symptoms of angina and quality of life assessed by score of the Seattle Angina Questionnaire (SAQ)
The SAQ provides results for 6 categories. The patient can receive between 0 and 100 points in each category, where 100 represents the best score.
Time frame: 6 months, 12 months, 24 months
Correlation of post-percutaneous coronary intervention (PCI) vessel fractional flow reserve (vFFR) with score of Seattle Angina Questionnaire (SAQ).
The SAQ provides results for 6 categories. The patient can receive between 0 and 100 points in each category, where 100 represents the best score. vFFR values are within the range 0-1, where higher values indicate better function.
Time frame: 6 months, 12 months, 24 months
Correlation of ΔvFFR with score of Seattle Angina Questionnaire (SAQ).
The SAQ provides results for 6 categories. The patient can receive between 0 and 100 points in each category, where 100 represents the best score.
Time frame: 6 months, 12 months, 24 months
Correlation of post-percutaneous coronary intervention (PCI) vessel fractional flow reserve (vFFR) with score of EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L).
The EQ-5D-5L scale asses the patient's self-rated health in five categories (each category 1-5) - higher values indicate worse performance. Additionally, the patient fulfill vertical visual analog scale from 0 to 100, where higher scores indicate better function. vFFR values are within the range 0-1, where higher values indicate better function.
Time frame: 6 months, 12 months, 24 months
Correlation of ΔvFFR with score of EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L).
The EQ-5D-5L scale asses the patient's self-rated health in five categories (each category 1-5) - higher values indicate worse performance. Additionally, the patient fulfill vertical visual analog scale from 0 to 100, where higher scores indicate better function.
Time frame: 6 months, 12 months, 24 months
AUC for the optimal cutoff point for post-percutaneous coronary intervention (PCI) vessel fractional flow reserve (vFFR) for significant prediction of MACE
MACE defined as all-cause death, target-vessel myocardial infarction (TVMI) and target vessel revascularization (TVR).
Time frame: 6 months, 12 months, 24 months
AUC for the optimal cutoff point for ΔvFFR useful for prediction of MACE
MACE defined as all-cause death, target-vessel myocardial infarction (TVMI) and target vessel revascularization (TVR).
Time frame: 6 months, 12 months, 24 months
AUC for the optimal cutoff point for post-percutaneous coronary intervention (PCI) vessel fractional flow reserve (vFFR) useful for prediction of higher than median SAQ score.
The SAQ provides results for 6 categories. The patient can receive between 0 and 100 points in each category, where 100 represents the best score. vFFR values are within the range 0-1, where higher values indicate better function.
Time frame: 6 months, 12 months, 24 months
AUC for the optimal cutoff point for post-percutaneous coronary intervention (PCI) vessel fractional flow reserve (vFFR) useful for prediction of higher than median EQ-5D-5L score.
The scale asses the patient's self-rated health in five categories (each category 1-5) - higher values indicate worse performance. Additionally, the patient fulfill vertical visual analog scale from 0 to 100, where higher scores indicate better function. vFFR values are within the range 0-1, where higher values indicate better function.
Time frame: 6 months, 12 months, 24 months
AUC for the optimal cutoff point for ΔvFFR useful for prediction of higher than median SAQ score.
The SAQ provides results for 6 categories. The patient can receive between 0 and 100 points in each category, where 100 represents the best score.
Time frame: 6 months, 12 months, 24 months
AUC for the optimal cutoff point for ΔvFFR useful for prediction of higher than median EQ-5D-5L score.
The scale asses the patient's self-rated health in five categories (each category 1-5) - higher values indicate worse performance. Additionally, the patient fulfill vertical visual analog scale from 0 to 100, where higher scores indicate better function.
Time frame: 6 months, 12 months, 24 months
Rate of revascularization of any vessel due to exacerbation of angina symptoms.
Decisions on the performance of revascularization will be made by the attending physician according to the clinical features and available methods.
Time frame: 6 months, 12 months, 24 months
Rate of definite and probable stent thrombosis.
Time frame: 6 months, 12 months, 24 months
Rate of clinically driven invasive coronary angiography due to exacerbation of angina symptoms.
Decisions on the performance of invasive coronary angiography will be made by the attending physician according to the clinical features.
Time frame: 6 months, 12 months, 24 months
AUC for the value of in-stent vFFR gradient in predicting the rate of MACE
vFFR values are within the range 0-1, where higher values indicate better function.
Time frame: 6 months, 12 months, 24 months
AUC for the value of 3-vessel post-PCI vFFR burden (sum of the vFFR estimated in the three main epicardial arteries) in predicting the rate of MACE
3-vessel post-PCI vFFR will be defined as the sum of the post-PCI vFFR values derived for each vessel (left anterior descending, circumflex, right coronary artery).
Time frame: 6 months, 12 months, 24 months
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