Post-Revascularization Optimization and PHysiological Evaluation of intermediaTe Lesions

Recruiting

• Conditions: Angina, Stable; Ischemic Heart Disease; Coronary Disease; Non ST Elevation Myocardial Infarction; Unstable Angina; ST Elevation Myocardial Infarction
• Interventions: Diagnostic Test: Invasive functional evaluation with either Pd/Pa, FFR, iFR or contrast FFR

• Registration Number: NCT05056662
• Lead Sponsor: Catholic University of the Sacred Heart

Brief Summary

PROPHET-FFR is a single center ambispective registry aiming to explore the impact of post-revascularization functional assessment on later outcomes.

Detailed Description

PROPHET-FFR is a ambispective observational study enrolling patients that need invasive functional evaluation in the diagnostic workup of coronary artery disease.

Clinical outcomes of patients that undergo functional assessment after PCI will be compared both to patients undergoing PCI without further evaluations and both to patients that will be deferred due to to negative functional evaluation.

Since the observational nature of the study the decision to perform post-PCI physiological assessment will be left to operator's discretion.

In case of post-PCI functional evaluation results that will be deemed as unsatisfactory by the operator further actions can be taken in order to optimize procedural result. The decision on this opportunity as well as the choice of the strategy to adopt are left to operator's discretion.

The primary endpoint of the study is the rate of MACE defined as the composite of spontaneous MI, target vessel failure, cardiac deaths at 24 months. Follow up will be performed by telephone contact and medical records screening at 12, 24 and 36 months.

Moreover data about in-hospital events will be collected including the release of myocardial damage markers, change in Creatinine, and lenght of hospital stay.

Study Timeline

• Study Start: 2020-06-04
• Study First Submitted: 2021-07-22
• Study First Submitted QC: 2021-09-23
• Study First Posted: 2021-09-24
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-08-30
• Primary Completion: 2025-06-04
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2	Invasive functional evaluation with either Pd/Pa, FFR, iFR or contrast FFR	Patients with positive invasive functional evaluation undergoing PCI
Group 3	Invasive functional evaluation with either Pd/Pa, FFR, iFR or contrast FFR	Patients with positive invasive functional evaluation undergoing PCI and subsequent retest of functional indexes
Group 1	Invasive functional evaluation with either Pd/Pa, FFR, iFR or contrast FFR	Patients with negative invasive functional evaluation

Primary Outcome Measures

Name	Time	Method
Rate of composite of Major Adverse Cardiovascular Events (MACE) [ Cardiac Death/Myocardial Infarction/Target Vessel Failure (TVF)]	2 years

Secondary Outcome Measures

Name	Time	Method
Rate of recurrent or persistent angina	1 year, 3 years, 5 years
contrast dose	intraprocedural	mL
Rate of cardiac hospitalizations	1 year, 3 years, 5 years	Any hospitalization for cardiac causes
absolute and relative change in functional indexes measured before and after any step of the study procedure	intraprocedural
post-procedural creatinine level	24 hours and 48 hours	mg/dL
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
procedural cost	intraprocedural	Euro
post-procedural troponin level	24 hours and 48 hours	ng/L
Percentage of change in angina intensity assessed by shortened Seattle Angina Questionnaire-7	1 year, 3 years, 5 years	A score ranging from 0 to 100, with the higher values associated with less severe symptoms
fluoroscopy time	intraprocedural	minutes
number of stents implanted and balloon used for optimization	intraprocedural

Trial Locations

Locations (1)

Policlinico Universitario Agostino Gemelli; 🇮🇹 Rome, RM, Italy