NCT03155022

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 750 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myocardial Infarction, Acute

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-04-12
• Primary completion: 2023-10-03
• Completion: 2023-10-03
• First posted: 2017-05-16
• Last updated: 2025-08-28

Locations

4 sites across 2 countries: Belgium, France