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.
1,123 studies on the registry are indexed under Myocardial Ischemia; 177 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 318 across 398 observational studies indexed under Myocardial Ischemia.
Browse Myocardial Ischemia studies →Catholic University of the Sacred Heart is the lead sponsor of 237 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients requiring invasive functional evaluation of epicardial stenosis to guide revascularization.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Started Jun 2020 (actual). Primary completion is estimated for Jun 2025, 60 months after the start.
Of 165 non-industry observational studies under Myocardial Ischemia, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 127. This study's planned 60 months is above that.
Counting every sponsor, half of 204 studies reached it within 40 months; a quarter within 21 and three quarters within 90.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Catholic University of the Sacred Heart →