Post-Revascularization Optimization and PHysiological Evaluation of intermediaTe Lesions
PROPHET-FFR
1 other identifier
observational
1,000
1 country
1
Brief Summary
PROPHET-FFR is a single center ambispective registry aiming to explore the impact of post-revascularization functional assessment on later outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 4, 2020
CompletedFirst Submitted
Initial submission to the registry
July 22, 2021
CompletedFirst Posted
Study publicly available on registry
September 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 4, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedAugust 30, 2023
August 1, 2023
5 years
July 22, 2021
August 29, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of composite of Major Adverse Cardiovascular Events (MACE) [ Cardiac Death/Myocardial Infarction/Target Vessel Failure (TVF)]
2 years
Secondary Outcomes (12)
Rate of any component of MACE (Cardiac Death/Myocardial Infarction/Target Vessel Failure (TVF)]
1 year, 3 years, 5 years
Rate of all-cause Death
1 year, 3 years, 5 years
Rate of recurrent or persistent angina
1 year, 3 years, 5 years
Percentage of change in angina intensity assessed by shortened Seattle Angina Questionnaire-7
1 year, 3 years, 5 years
Rate of cardiac hospitalizations
1 year, 3 years, 5 years
- +7 more secondary outcomes
Study Arms (3)
Group 1
Patients with negative invasive functional evaluation
Group 2
Patients with positive invasive functional evaluation undergoing PCI
Group 3
Patients with positive invasive functional evaluation undergoing PCI and subsequent retest of functional indexes
Interventions
Enrolled patients will undergo invasive functional evaluation of coronary stenosis followed by percutaneous revascularization if appropriate. Patients in Group 3 will have target lesion re-assessed using either PdPa, FFR, iFR or contrast FFR.
Eligibility Criteria
Patients requiring invasive functional evaluation of epicardial stenosis to guide revascularization.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Policlinico Universitario Agostino Gemelli
Rome, RM, Italy
Related Publications (1)
Galante D, Migliaro S, Di Giusto F, Anastasia G, Petrolati E, Vicere A, Zimbardo G, Cialdella P, Romagnoli E, Aurigemma C, Burzotta F, Trani C, Martin-Reyes R, Baptista SB, Faria D, Amabile N, Raposo L, Crea F, Leone AM. Age and Vasodilator Response to Different Hyperemic Agents: Adenosine versus Contrast Medium. Rev Cardiovasc Med. 2024 Jul 2;25(7):239. doi: 10.31083/j.rcm2507239. eCollection 2024 Jul.
PMID: 39139436DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Head of Chronic Coronary Syndromes Department at Fondazione Policlinico A. Gemelli
Study Record Dates
First Submitted
July 22, 2021
First Posted
September 24, 2021
Study Start
June 4, 2020
Primary Completion
June 4, 2025
Study Completion
October 1, 2025
Last Updated
August 30, 2023
Record last verified: 2023-08