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TERMINATED
NCT03155022
NA

Combined Application of Remote and Intra-Coronary Ischemic Conditioning in Acute Myocardial Infarction

Sponsor: Hospices Civils de Lyon

View on ClinicalTrials.gov

Summary

Infarct size is a major determinant of prognosis after AMI. Evidence indicates that the combination of intracoronary ischemic conditioning (ICIC) and remote ischemic conditioning (RIC) can significantly reduce infarct size in STEMI patients. Whether the combination of these two interventions may improve clinical outcome after STEMI remains unknown. The objective of the present study is to determine whether combination of ICIC and RIC can improve STEMI patients clinical outcome at 6 months.

Official title: Combined Application of Remote and Intra-Coronary Ischemic Conditioning in Acute Myocardial Infarction: A Multicenter, Randomized, Controlled Clinical Trial (CARIOCA Study)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

750

Start Date

2018-04-12

Completion Date

2023-10-03

Last Updated

2026-05-08

Healthy Volunteers

No

Interventions

DEVICE

Remote ischemic conditioning and intracoronary ischemic conditioning

RIC: Four cycles of \[5 min brachial cuff inflation at 200 mmHg followed by 5 min of cuff deflation\] started as soon as possible prior to PCI reperfusion. At least one full cycle (inflation + deflation) has to be completed before PCI reperfusion. ICIC: Four cycles of \[1 min balloon inflation followed by 1 min balloon deflation\] started as soon as possible after reopening of the culprit coronary artery (maximum within 3 minutes after reflow). The balloon will be placed carefully above the culprit lesion so as to minimize potential micro-embolization.

DEVICE

Patients with no remote ischemic conditioning and no intracoronary ischemic conditioning

Brachial cuff is positioned during 40 minutes but not inflated. No intracoronary balloon inflation.

Locations (4)

Algemeen Ziekenhuis Sint Jan

Bruges, Belgium

CHU de Charleroi

Charleroi, Belgium

Universitair Ziekenhuis Antwerpen

Edegem, Belgium

Hopital Louis Pradel

Bron, France