Post-Revascularization Optimization and PHysiological Evaluation of intermediaTe Lesions (PROPHET-FFR)

Post-Revascularization Optimization and PHysiological Evaluation of intermediaTe Lesions: an FFR-based Single Center Registry

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

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Antonio Maria Leone, PI; Phone Number: 0630155950; Email: antoniomarialeone@gmail.com

Study Locations

• Italy
  • RM
    • Rome, RM, Italy
      • Recruiting
      • Policlinico Universitario Agostino Gemelli
      • Contact: ANTONIO MARIA LEONE, PI; Email: antoniomarialeone@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients requiring invasive functional evaluation of epicardial stenosis to guide revascularization.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Patients with negative invasive functional evaluation	Diagnostic test: Invasive functional evaluation with either Pd/Pa, FFR, iFR or contrast FFR; 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.
Group 2; Patients with positive invasive functional evaluation undergoing PCI	Diagnostic test: Invasive functional evaluation with either Pd/Pa, FFR, iFR or contrast FFR; 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.
Group 3; Patients with positive invasive functional evaluation undergoing PCI and subsequent retest of functional indexes	Diagnostic test: Invasive functional evaluation with either Pd/Pa, FFR, iFR or contrast FFR; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	A score ranging from 0 to 100, with the higher values associated with less severe symptoms	1 year, 3 years, 5 years
Rate of cardiac hospitalizations	Any hospitalization for cardiac causes	1 year, 3 years, 5 years
absolute and relative change in functional indexes measured before and after any step of the study procedure		intraprocedural
post-procedural troponin level	ng/L	24 hours and 48 hours
post-procedural creatinine level	mg/dL	24 hours and 48 hours
procedural cost	Euro	intraprocedural
fluoroscopy time	minutes	intraprocedural
contrast dose	mL	intraprocedural
number of stents implanted and balloon used for optimization		intraprocedural

Collaborators and Investigators

• Sponsor: Catholic University of the Sacred Heart
• Collaborators: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2020
• Primary Completion (Estimated): June 4, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: July 22, 2021
• First Submitted That Met QC Criteria: September 23, 2021
• First Posted (Actual): September 24, 2021

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Chest Pain; Myocardial Infarction; Infarction; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; ST Elevation Myocardial Infarction; Angina Pectoris; Angina, Stable; Angina, Unstable; Non-ST Elevated Myocardial Infarction
• Other Study ID Numbers: 3237

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No