Medical University of Warsaw
Warsaw, 02-097, Poland
Location status: Recruiting
Recruiting
NCT Number: NCT06255678
Angio-based Final Functional Effect of PCI
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About 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:
- Diabetes/non-diabetes
- Glomerular filtration rate (GFR)≥60/GFR<60 [ml/min./1,73m2]
- Focal/diffuse atherosclerosis
- Multivessel/single-vessel disease
- CCS/NST-ACS/STEMI
- CCS/ACS
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Percutaneous coronary intervention (PCI) for chronic coronary syndromes (CCS) or acute coronary syndromes (ACS)
- Adequate quality of angiogram enabling vFFR analysis (available two angiographic views with ≥30° differences in rotation/angulation, the possibility of vessel contour selection, proper quality of the images, vessels without severe overlapping, tortuosity, foreshortening and poor vessel opacification)
- Age >18 years
- The patient's written informed consent has been obtained before the procedure
Exclusion criteria
- Cardiogenic shock, pulmonary oedema
- Severe hemodynamical instability
- Prior coronary artery bypass grafting (CABG)
- Active bleeding
- Acute and chronic inflammatory conditions
- Acute mechanical complications of myocardial infarction
- Congenital heart disease
- Heart transplantation
- Non-cardiac comorbidities with a life expectancy of less than 1 year
Treatment and study plan
Angiography-based vessel fractional flow reserve (vFFR) calculation
Diagnostic TestvFFR is calculated from routinely taken angiography images during PCI using a CAAS workstation (Pie Medical Imaging, Maastricht, the Netherlands)
Primary outcomes
-
Rate of MACE defined as all-cause death, target-vessel myocardial infarction (TVMI) and target vessel revascularization (TVR).
Time frame: 24 months
Secondary outcomes
-
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)
Time frame: 6 months, 12 months, 24 months
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.
-
Symptoms of angina and quality of life assessed by score of the Seattle Angina Questionnaire (SAQ)
Time frame: 6 months, 12 months, 24 months
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.
-
Correlation of post-percutaneous coronary intervention (PCI) vessel fractional flow reserve (vFFR) with score of Seattle Angina Questionnaire (SAQ).
Time frame: 6 months, 12 months, 24 months
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.
-
Correlation of ΔvFFR with score of Seattle Angina Questionnaire (SAQ).
Time frame: 6 months, 12 months, 24 months
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.
-
Correlation of post-percutaneous coronary intervention (PCI) vessel fractional flow reserve (vFFR) with score of EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L).
Time frame: 6 months, 12 months, 24 months
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.
-
Correlation of ΔvFFR with score of EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L).
Time frame: 6 months, 12 months, 24 months
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.
-
AUC for the optimal cutoff point for post-percutaneous coronary intervention (PCI) vessel fractional flow reserve (vFFR) for significant prediction of MACE
Time frame: 6 months, 12 months, 24 months
MACE defined as all-cause death, target-vessel myocardial infarction (TVMI) and target vessel revascularization (TVR).
-
AUC for the optimal cutoff point for ΔvFFR useful for prediction of MACE
Time frame: 6 months, 12 months, 24 months
MACE defined as all-cause death, target-vessel myocardial infarction (TVMI) and target vessel revascularization (TVR).
-
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.
Time frame: 6 months, 12 months, 24 months
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.
-
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.
Time frame: 6 months, 12 months, 24 months
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.
-
AUC for the optimal cutoff point for ΔvFFR useful for prediction of higher than median SAQ score.
Time frame: 6 months, 12 months, 24 months
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.
-
AUC for the optimal cutoff point for ΔvFFR useful for prediction of higher than median EQ-5D-5L score.
Time frame: 6 months, 12 months, 24 months
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.
-
Rate of revascularization of any vessel due to exacerbation of angina symptoms.
Time frame: 6 months, 12 months, 24 months
Decisions on the performance of revascularization will be made by the attending physician according to the clinical features and available methods.
-
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.
Time frame: 6 months, 12 months, 24 months
Decisions on the performance of invasive coronary angiography will be made by the attending physician according to the clinical features.
-
AUC for the value of in-stent vFFR gradient in predicting the rate of MACE
Time frame: 6 months, 12 months, 24 months
vFFR values are within the range 0-1, where higher values indicate better function.
-
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
Time frame: 6 months, 12 months, 24 months
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).
Study contacts
Contact information is provided by the study sponsor or research team.
Karol Sadowski
CONTACT
Mariusz Tomaniak, MD PhD
CONTACT
Sponsors and collaborators
Lead sponsor
Medical University of Warsaw
Other
Registry information
Official study title
Angio-based Final Functional Effect of PCI (AFFE PCI): a Prospective Multi-center Study of Post-PCI vFFR Impact on Clinical Outcomes and Residual Angina
Acronym: AFFE-PCI
Important dates
- Study start
- 2023
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Feb 13, 2024
- Registry last updated
- Feb 13, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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