Clinical trial NCT05056662: Post-Revascularization Optimization and PHysiological Evaluation of intermediaTe Lesions
Official title: Post-Revascularization Optimization and PHysiological Evaluation of intermediaTe Lesions: an FFR-based Single Center Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Heart Disease
Angina, Stable
Non ST Elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Unstable Angina
Coronary Disease
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
Collaborators: name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
First posted: 2021-09-24
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring invasive functional evaluation of epicardial stenosis to guide revascularization.

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.

Eligibility 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.

Primary outcomes:
measure: Rate of composite of Major Adverse Cardiovascular Events (MACE) [ Cardiac Death/Myocardial Infarction/Target Vessel Failure (TVF)]
timeFrame: 2 years
Secondary outcomes:
measure: Rate of any component of MACE (Cardiac Death/Myocardial Infarction/Target Vessel Failure (TVF)]
timeFrame: 1 year, 3 years, 5 years
measure: Rate of all-cause Death
timeFrame: 1 year, 3 years, 5 years
measure: Rate of recurrent or persistent angina
timeFrame: 1 year, 3 years, 5 years
measure: Percentage of change in angina intensity assessed by shortened Seattle Angina Questionnaire-7
timeFrame: 1 year, 3 years, 5 years
measure: Rate of cardiac hospitalizations
timeFrame: 1 year, 3 years, 5 years
measure: absolute and relative change in functional indexes measured before and after any step of the study procedure
timeFrame: intraprocedural
measure: post-procedural troponin level
timeFrame: 24 hours and 48 hours
measure: post-procedural creatinine level
timeFrame: 24 hours and 48 hours
measure: procedural cost
timeFrame: intraprocedural
measure: fluoroscopy time
timeFrame: intraprocedural
measure: contrast dose
timeFrame: intraprocedural
measure: number of stents implanted and balloon used for optimization
timeFrame: intraprocedural
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Policlinico Universitario Agostino Gemelli
state: RM
Study officials:
References: