Post-Revascularization Optimization and PHysiological Evaluation of intermediaTe Lesions

NCT ID: NCT05056662

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-04
• Study Completion Date: 2025-10-01

Brief Summary

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

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.

Conditions

Ischemic Heart Disease; Angina, Stable; Non ST Elevation Myocardial Infarction; ST Elevation Myocardial Infarction; Unstable Angina; Coronary Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

Patients with negative invasive functional evaluation

Invasive functional evaluation with either Pd/Pa, FFR, iFR or contrast FFR

Intervention Type: 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.

Group 2

Patients with positive invasive functional evaluation undergoing PCI

Invasive functional evaluation with either Pd/Pa, FFR, iFR or contrast FFR

Intervention Type: 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.

Group 3

Patients with positive invasive functional evaluation undergoing PCI and subsequent retest of functional indexes

Invasive functional evaluation with either Pd/Pa, FFR, iFR or contrast FFR

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: collaborator

Catholic University of the Sacred Heart

OTHER

Sponsor Role: lead

Responsible Party

Antonio Maria Leone, MD

Principal Investigator, Head of Chronic Coronary Syndromes Department at Fondazione Policlinico A. Gemelli

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Policlinico Universitario Agostino Gemelli

Rome, RM, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Antonio Maria Leone, PI

Role: CONTACT

antoniomarialeone@gmail.com

0630155950

Facility Contacts

ANTONIO MARIA LEONE, PI

Role: primary

antoniomarialeone@gmail.com

References

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.

Reference Type: DERIVED

PMID: 39139436 (View on PubMed)

Other Identifiers

3237

Identifier Type: -

Identifier Source: org_study_id