Evaluating the impact of angiography-based FFR after heart procedures
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
Medical University of Warsaw · NCT06255678
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 |
|---|---|
| Enrollment | 2005 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Warsaw (other) |
| Locations | 1 site (Warsaw) |
| Trial ID | NCT06255678 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 undergoing PCI for chronic or acute coronary syndromes with suitable angiogram quality.
Not a fit: Patients with severe hemodynamic instability, prior CABG, or significant non-cardiac comorbidities may not benefit from this study.
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 performed: Previous studies have shown promising results with similar approaches using vFFR, indicating potential for this study's success.
Eligibility criteria
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 this trial is running
Warsaw
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Coronary Syndrome, Non ST Segment Elevation Acute Coronary Syndrome, Chronic Coronary Syndrome, vFFR, ACS, NST-ACS, Angiography-based FFR, Quality of life