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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date August 2023
Source Catholic University of the Sacred Heart
Contact Antonio Maria Leone, PI
Phone 0630155950
Email antoniomarialeone@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Italy Policlinico Universitario Agostino Gemelli Rome RM

Sponsors (2)

Lead Sponsor Collaborator
Catholic University of the Sacred Heart Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

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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