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Functional Coronary Angiography Guided Revascularization in STEMI - Trial NCT05818475

Access comprehensive clinical trial information for NCT05818475 through Pure Global AI's free database. This phase not specified trial is sponsored by University Hospital of Ferrara and is currently Recruiting. The study focuses on Myocardial Infarction. Target enrollment is 1800 participants.

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NCT05818475
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Trial Details
ClinicalTrials.gov โ€ข NCT05818475
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Functional Coronary Angiography Guided Revascularization in STEMI
Functional Coronary Angiography to Indicate and Guide Revascularization in STEMI Patients With Multivessel Disease

Study Focus

Myocardial Infarction

Angiography-guided PCI

Interventional

other

Sponsor & Location

University Hospital of Ferrara

Bologna,Ferrara,Reggio Emilia, Italy

Timeline & Enrollment

N/A

May 08, 2023

May 08, 2028

1800 participants

Primary Outcome

Primary Efficacy Outcome: Patient Oriented Composite Outcome,Primary Safety Outcome: Major Bleeding and Contrast - Associated Acute Kidney Injury

Summary

The goal of this multicenter randomized clinical trial is to test the superiority in terms of
 efficacy of the Angiography-derived fractional flow reserve (AIR) over that based on
 conventional angiography (ANGIO) strategy in the management of non-culprit lesions in STEMI
 patients with multivessel disease.
 
 The main questions it aims to answer are:
 
 - is an Angiography-derived fractional flow reserve strategy superior to a conventional
 angiography strategy in reducing the occurrence of the composite efficacy endpoint of
 all-cause death, myocardial infarction, cerebrovascular accident, or ischemia-driven
 revascularization.
 
 - is an Angiography-derived fractional flow reserve strategy superior to a conventional
 angiography strategy in reducing the occurrence of the composite safety endpoint of of
 contrast-associated acute kidney injury and Bleeding Academic Research Consortium (BARC)
 type 3-5.
 
 Participants will be randomized after the successful treatment of the culprit lesion to one
 of the two strategies and prospectively followed-up.

ICD-10 Classifications

Acute myocardial infarction
Acute myocardial infarction, unspecified
Old myocardial infarction
Subsequent myocardial infarction
Observation for suspected myocardial infarction

Data Source

ClinicalTrials.gov

NCT05818475

Non-Device Trial