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

Civil Hospices of Lyon

Status: Completed

Conditions: Myocardial Infarction, Acute

Treatments: Device: Patients with no remote ischemic conditioning and no intracoronary ischemic conditioning; Device: Remote ischemic conditioning and intracoronary ischemic conditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT03155022

69HCL17_0032

2017-A01683-50 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 750 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All (male and female) patients, aged over 18,
• Presenting within 12 hours of the onset of chest pain,
• For whom the clinical decision was made to treat with percutaneous coronary intervention (PCI),
• ST segment elevation ≥ 0.2 mV in two contiguous ECG leads,
• Written informed consent obtained or oral informed consent certified by a third party.

Non inclusion Criteria:

• Patients with cardiogenic shock,
• Patients with uncontrolled (treated or untreated) hypertension (> 180/110 mmHg),
• Patients with loss of consciousness or confused,
• Patients without health coverage,
• Patient with any legal protection measure,
• Female patients currently pregnant (oral diagnosis) or women of childbearing age who were not using contraception.

Exclusion criteria

Patients with main occlusion localized on :

• LAD: distal or ostial segment,
• Non dominant RCA / CX: mid or distal segment,
• Dominant RCA / CX: distal segment,
• Any other arteries apart LAD/CX/RCA; Patients with evidence of coronary collaterals to the risk region (Rentrop score ≥ 2); Patients with an opened (TIMI > 1) culprit coronary artery on initial admission coronary angiography or a failed PCI (final TIMI=0).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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750 participants in 2 patient groups

RIC+ ICIC +

Experimental group

Description:

Patients with remote ischemic conditioning and intracoronary ischemic conditioning

Treatment:

Device: Remote ischemic conditioning and intracoronary ischemic conditioning

RCI - ICIC -

Other group

Description:

Control group with no remote ischemic conditioning and no intracoronary ischemic conditioning

Treatment:

Device: Patients with no remote ischemic conditioning and no intracoronary ischemic conditioning