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| Name | Class |
|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Patients with negative invasive functional evaluation |
| |
| Group 2 | Patients with positive invasive functional evaluation undergoing PCI |
| |
| Group 3 | Patients with positive invasive functional evaluation undergoing PCI and subsequent retest of functional indexes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Invasive functional evaluation with either Pd/Pa, FFR, iFR or contrast FFR | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of composite of Major Adverse Cardiovascular Events (MACE) [ Cardiac Death/Myocardial Infarction/Target Vessel Failure (TVF)] | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of any component of MACE (Cardiac Death/Myocardial Infarction/Target Vessel Failure (TVF)] | 1 year, 3 years, 5 years | |
| Rate of all-cause Death | 1 year, 3 years, 5 years | |
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Inclusion Criteria:
Exclusion Criteria:
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Patients requiring invasive functional evaluation of epicardial stenosis to guide revascularization.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio Maria Leone, PI | Contact | 0630155950 | antoniomarialeone@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico Universitario Agostino Gemelli | Recruiting | Rome | RM | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39139436 | Derived | Galante D, Migliaro S, Di Giusto F, Anastasia G, Petrolati E, Vicere A, Zimbardo G, Cialdella P, Romagnoli E, Aurigemma C, Burzotta F, Trani C, Martin-Reyes R, Baptista SB, Faria D, Amabile N, Raposo L, Crea F, Leone AM. Age and Vasodilator Response to Different Hyperemic Agents: Adenosine versus Contrast Medium. Rev Cardiovasc Med. 2024 Jul 2;25(7):239. doi: 10.31083/j.rcm2507239. eCollection 2024 Jul. |
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|
| Rate of recurrent or persistent angina |
| 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 | 1 year, 3 years, 5 years |
| Rate of cardiac hospitalizations | Any hospitalization for cardiac causes | 1 year, 3 years, 5 years |
| absolute and relative change in functional indexes measured before and after any step of the study procedure | intraprocedural |
| post-procedural troponin level | ng/L | 24 hours and 48 hours |
| post-procedural creatinine level | mg/dL | 24 hours and 48 hours |
| procedural cost | Euro | intraprocedural |
| fluoroscopy time | minutes | intraprocedural |
| contrast dose | mL | intraprocedural |
| number of stents implanted and balloon used for optimization | intraprocedural |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D060050 | Angina, Stable |
| D000072658 | Non-ST Elevated Myocardial Infarction |
| D000072657 | ST Elevation Myocardial Infarction |
| D000789 | Angina, Unstable |
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D000787 | Angina Pectoris |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009203 | Myocardial Infarction |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D009336 | Necrosis |
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