An observational study in Ischemic Heart Disease, Angina, Stable and Non ST Elevation Myocardial Infarction, sponsored by Catholic University of the Sacred Heart. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-30.
Sponsored by Catholic University of the Sacred Heart · Observational
PROPHET-FFR is a single center ambispective registry aiming to explore the impact of post-revascularization functional assessment on later outcomes.
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.
Patients requiring invasive functional evaluation of epicardial stenosis to guide revascularization.
Exclusion Criteria:
Patients with negative invasive functional evaluation
Diagnostic Test: Invasive functional evaluation with either Pd/Pa, FFR, iFR or contrast FFR
Patients with positive invasive functional evaluation undergoing PCI
Diagnostic Test: 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
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.
Rate of composite of Major Adverse Cardiovascular Events (MACE) [ Cardiac Death/Myocardial Infarction/Target Vessel Failure (TVF)]
Time frame: 2 years
Rate of any component of MACE (Cardiac Death/Myocardial Infarction/Target Vessel Failure (TVF)]
Time frame: 1 year, 3 years, 5 years
Rate of all-cause Death
Time frame: 1 year, 3 years, 5 years
Rate of recurrent or persistent angina
Time frame: 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
Time frame: 1 year, 3 years, 5 years
Rate of cardiac hospitalizations
Any hospitalization for cardiac causes
Time frame: 1 year, 3 years, 5 years
absolute and relative change in functional indexes measured before and after any step of the study procedure
Time frame: intraprocedural
post-procedural troponin level
ng/L
Time frame: 24 hours and 48 hours
post-procedural creatinine level
mg/dL
Time frame: 24 hours and 48 hours
procedural cost
Euro
Time frame: intraprocedural
fluoroscopy time
minutes
Time frame: intraprocedural
contrast dose
mL
Time frame: intraprocedural
number of stents implanted and balloon used for optimization
Time frame: intraprocedural
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Catholic University of the Sacred Heart