Evaluating heart function after revascularization procedures
Post-Revascularization Optimization and PHysiological Evaluation of intermediaTe Lesions: an FFR-based Single Center Registry
This study is testing whether doing extra heart function checks after a procedure to open blocked arteries helps people with coronary artery disease avoid serious heart problems in the following two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Catholic University of the Sacred Heart Academic / other |
| Locations | 1 site (Rome, RM) |
| Trial ID | NCT05056662 on ClinicalTrials.gov |
What this trial studies
PROPHET-FFR is an ambispective observational registry that aims to assess the impact of post-revascularization functional evaluations on patient outcomes in those with coronary artery disease. The study will enroll patients requiring invasive functional assessment and compare clinical outcomes between those who undergo further evaluations after percutaneous coronary intervention (PCI) and those who do not. The primary endpoint is the rate of major adverse cardiac events (MACE) over 24 months, with follow-up conducted through telephone contacts and medical record reviews. The decision to perform additional evaluations will be at the operator's discretion, allowing for tailored patient management.
Who should consider this trial
Good fit: Ideal candidates are patients requiring coronary angiography with at least one intermediate coronary stenosis needing functional assessment.
Not a fit: Patients with severe uncontrolled pulmonary disease, hemodynamic instability, or life expectancy of less than one year may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve patient outcomes by optimizing treatment strategies based on functional assessments after heart procedures.
How similar studies have performed: Other studies have shown promise in using functional assessments post-PCI, suggesting this approach may yield beneficial insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * requiring coronary angiography to assess coronary artery disease; * having at least one angiographically intermediate coronary stenosis (eg. 40%-80%) on any vessel requiring invasive functional assessment using FFR (and/or any other surrogate index) * being able and legally entitled to give informed consent Exclusion Criteria: * history of severe poorly uncontrolled pulmonary disease * hemodynamic instability during the diagnostic or therapeutic procedures; * known adenosine intolerance * need of mechanical circulatory or ventilatory support; * stage IV chronic kidney disease. * life expectancy \<1 year * patients gaining indication to surgical revascularization; * major procedural complications during percutaneous revascularization (cardiac arrest needing cardiopulmonary resuscitation, major bleeding , large iatrogenic coronary dissection, coronary embolization in a main vessel, suspected stroke) making post-PCI functional evaluation unsafe or impossible.
Where this trial is running
Rome, RM
- Policlinico Universitario Agostino Gemelli — Rome, Rm, Italy (Recruiting)
Study contacts
- Study coordinator: Antonio Maria Leone, PI
- Email: antoniomarialeone@gmail.com
- Phone: 0630155950
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.