Coronary Disease Clinical Trial
— PROPHET-FFROfficial title:
Post-Revascularization Optimization and PHysiological Evaluation of intermediaTe Lesions: an FFR-based Single Center Registry
NCT number | NCT05056662 |
Other study ID # | 3237 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 4, 2020 |
Est. completion date | October 1, 2025 |
PROPHET-FFR is a single center ambispective registry aiming to explore the impact of post-revascularization functional assessment on later outcomes.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | October 1, 2025 |
Est. primary completion date | June 4, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | Policlinico Universitario Agostino Gemelli | Rome | RM |
Lead Sponsor | Collaborator |
---|---|
Catholic University of the Sacred Heart | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of composite of Major Adverse Cardiovascular Events (MACE) [ Cardiac Death/Myocardial Infarction/Target Vessel Failure (TVF)] | 2 years | ||
Secondary | Rate of any component of MACE (Cardiac Death/Myocardial Infarction/Target Vessel Failure (TVF)] | 1 year, 3 years, 5 years | ||
Secondary | Rate of all-cause Death | 1 year, 3 years, 5 years | ||
Secondary | Rate of recurrent or persistent angina | 1 year, 3 years, 5 years | ||
Secondary | 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 | |
Secondary | Rate of cardiac hospitalizations | Any hospitalization for cardiac causes | 1 year, 3 years, 5 years | |
Secondary | absolute and relative change in functional indexes measured before and after any step of the study procedure | intraprocedural | ||
Secondary | post-procedural troponin level | ng/L | 24 hours and 48 hours | |
Secondary | post-procedural creatinine level | mg/dL | 24 hours and 48 hours | |
Secondary | procedural cost | Euro | intraprocedural | |
Secondary | fluoroscopy time | minutes | intraprocedural | |
Secondary | contrast dose | mL | intraprocedural | |
Secondary | number of stents implanted and balloon used for optimization | intraprocedural |
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