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NCT05818475Recruiting

Functional Coronary Angiography Guided Revascularization in STEMI

Functional Coronary Angiography to Indicate and Guide Revascularization in STEMI Patients With Multivessel Disease
University Hospital of FerraraClinicalTrials.govother
Study focus
Disease/Condition
Myocardial Infarction
Drug/Device/Intervention
Angiography-guided PCI
Study type
Interventional
Intervention type
other
Sponsor & location
Primary sponsor
University Hospital of Ferrara
Location
Bologna,Ferrara,Reggio Emilia, Italy
Timeline & enrollment
Phase
N/A
Start date
May 08, 2023
End date
May 08, 2028
Enrollment
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 infarctionAcute myocardial infarction, unspecifiedOld myocardial infarctionSubsequent myocardial infarctionObservation for suspected myocardial infarction
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05818475
Type
Non-Device Trial
About this record

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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