Post-Revascularization Optimization and PHysiological Evaluation of intermediaTe Lesions

Coronary Disease Clinical Trial

— PROPHET-FFR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05056662
• Other study ID #: 3237
• Status: Recruiting
• Start date: June 4, 2020
• Est. completion date: October 1, 2025

Study information

• Verified date: August 2023
• Source: Catholic University of the Sacred Heart
• Contact: Antonio Maria Leone, PI
• Phone: 0630155950
• Email: antoniomarialeone[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: October 1, 2025
• Est. primary completion date: June 4, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Angina, Unstable
• Coronary Artery Disease
• Coronary Disease
• Infarction
• Ischemic Heart Disease
• Myocardial Infarction
• Myocardial Ischemia
• Non ST Elevation Myocardial Infarction
• Non-ST Elevated Myocardial Infarction
• ST Elevation Myocardial Infarction
• Unstable Angina

Intervention

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.

Locations

Country	Name	City	State
Italy	Policlinico Universitario Agostino Gemelli	Rome	RM

Sponsors (2)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart	Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of composite of Major Adverse Cardiovascular Events (MACE) [ Cardiac Death/Myocardial Infarction/Target Vessel Failure (TVF)]		2 years
Secondary	Rate of any component of MACE (Cardiac Death/Myocardial Infarction/Target Vessel Failure (TVF)]		1 year, 3 years, 5 years
Secondary	Rate of all-cause Death		1 year, 3 years, 5 years
Secondary	Rate of recurrent or persistent angina		1 year, 3 years, 5 years
Secondary	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
Secondary	Rate of cardiac hospitalizations	Any hospitalization for cardiac causes	1 year, 3 years, 5 years
Secondary	absolute and relative change in functional indexes measured before and after any step of the study procedure		intraprocedural
Secondary	post-procedural troponin level	ng/L	24 hours and 48 hours
Secondary	post-procedural creatinine level	mg/dL	24 hours and 48 hours
Secondary	procedural cost	Euro	intraprocedural
Secondary	fluoroscopy time	minutes	intraprocedural
Secondary	contrast dose	mL	intraprocedural
Secondary	number of stents implanted and balloon used for optimization		intraprocedural