Evaluating the impact of angiography-based FFR after heart procedures
Official 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
Run by Medical University of Warsaw · NCT06255678 · Data updated 2026-11-12
This study is trying to see if measuring blood flow in heart arteries after a heart procedure can help predict serious heart problems and improve patients' quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2005 (estimated) |
| Sponsor | Medical University of Warsaw Academic / other |
| Locations | 1 site (Warsaw) |
| Status | Recruiting |
| Started | July 3, 2023 |
| Main results expected | January 1, 2027 |
| Study ends | January 1, 2027 |
| Registry record updated | February 13, 2024 |
| Trial ID | NCT06255678 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 undergoing PCI for chronic or acute coronary syndromes with suitable angiogram quality.
✕Probably not a fit
Patients with severe hemodynamic instability, prior CABG, or significant non-cardiac comorbidities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the relationship between angiography-based vessel fractional flow reserve (vFFR) after percutaneous coronary intervention (PCI) and adverse clinical outcomes, including major cardiovascular events and quality of life. It will involve a multicenter registry that tracks patients undergoing PCI for various coronary syndromes, utilizing validated questionnaires to measure health outcomes at 6 and 24 months post-procedure. The study will analyze data from coronary angiograms to determine the prognostic value of post-PCI vFFR and its changes from pre-PCI measurements.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of post-PCI patient outcomes and improve management strategies for coronary artery disease.
How similar studies have gone: Previous studies have shown promising results with similar approaches using vFFR, indicating potential for this study's success.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Medical University of Warsaw
Warsaw, Poland Recruiting
Study contacts
- Study coordinator: Mariusz Tomaniak, MD PhD
- Email: mariusz.tomaniak@wum.edu.pl
- Phone: +48 22 5991951
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This study is creating a registry to help doctors better understand and treat patients in South East Netherlands who have had heart procedures, aiming to reduce their risk of future heart problems.
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This trial tests starting Tafolecimab early in people with acute coronary syndrome who are having PCI to lower bad cholesterol quickly and see if it reduces heart problems after discharge.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.