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

Catholic University of the Sacred Heart

Status

Enrolling

Conditions

Ischemic Heart Disease

ST Elevation Myocardial Infarction

Unstable Angina

Angina, Stable

Non ST Elevation Myocardial Infarction

Coronary Disease

Treatments

Diagnostic Test: Invasive functional evaluation with either Pd/Pa, FFR, iFR or contrast FFR

Study type

Observational

Funder types

Other

Identifiers

NCT05056662

3237

Details and patient eligibility

About

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

Full 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.

Enrollment

1,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.