PROPHET-FFR: Post-Revascularization Optimization and PHysiological Evaluation of intermediaTe Lesions

Sponsor
Catholic University of the Sacred Heart (Other)
Overall Status
Recruiting
CT.gov ID
NCT05056662
Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
1,000
1
63.9
15.6

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Invasive functional evaluation with either Pd/Pa, FFR, iFR or contrast FFR

Detailed 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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Post-Revascularization Optimization and PHysiological Evaluation of intermediaTe Lesions: an FFR-based Single Center Registry
Actual Study Start Date :
Jun 4, 2020
Anticipated Primary Completion Date :
Jun 4, 2025
Anticipated Study Completion Date :
Oct 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Group 1

Patients with negative invasive functional evaluation

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.

Group 2

Patients with positive invasive functional evaluation undergoing PCI

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.

Group 3

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.

Outcome Measures

Primary Outcome Measures

  1. Rate of composite of Major Adverse Cardiovascular Events (MACE) [ Cardiac Death/Myocardial Infarction/Target Vessel Failure (TVF)] [2 years]

Secondary Outcome Measures

  1. Rate of any component of MACE (Cardiac Death/Myocardial Infarction/Target Vessel Failure (TVF)] [1 year, 3 years, 5 years]

  2. Rate of all-cause Death [1 year, 3 years, 5 years]

  3. Rate of recurrent or persistent angina [1 year, 3 years, 5 years]

  4. Percentage of change in angina intensity assessed by shortened Seattle Angina Questionnaire-7 [1 year, 3 years, 5 years]

    A score ranging from 0 to 100, with the higher values associated with less severe symptoms

  5. Rate of cardiac hospitalizations [1 year, 3 years, 5 years]

    Any hospitalization for cardiac causes

  6. absolute and relative change in functional indexes measured before and after any step of the study procedure [intraprocedural]

  7. post-procedural troponin level [24 hours and 48 hours]

    ng/L

  8. post-procedural creatinine level [24 hours and 48 hours]

    mg/dL

  9. procedural cost [intraprocedural]

    Euro

  10. fluoroscopy time [intraprocedural]

    minutes

  11. contrast dose [intraprocedural]

    mL

  12. number of stents implanted and balloon used for optimization [intraprocedural]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Policlinico Universitario Agostino Gemelli Rome RM Italy

Sponsors and Collaborators

  • Catholic University of the Sacred Heart
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Antonio Maria Leone, MD, Principal Investigator, Head of Chronic Coronary Syndromes Department at Fondazione Policlinico A. Gemelli, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier:
NCT05056662
Other Study ID Numbers:
  • 3237
First Posted:
Sep 24, 2021
Last Update Posted:
Sep 24, 2021
Last Verified:
Sep 1, 2021

Study Results

No Results Posted as of Sep 24, 2021