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

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

Conditions
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Myocardial Infarction, Acute

Intervention / Treatment
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* Device: Remote ischemic conditioning and intracoronary ischemic conditioning
* Device: Patients with no remote ischemic conditioning and no intracoronary ischemic conditioning


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RIC+ ICIC +<br>Patients with remote ischemic conditioning and intracoronary ischemic conditioning | Device: Remote ischemic conditioning and intracoronary ischemic conditioning<br>* 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.<br>|
| Other: RCI - ICIC -<br>Control group with no remote ischemic conditioning and no intracoronary ischemic conditioning | Device: Patients with no remote ischemic conditioning and no intracoronary ischemic conditioning<br>* Brachial cuff is positioned during 40 minutes but not inflated. No intracoronary balloon inflation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined incidence of [all-cause mortality; worsening of heart failure during initial hospitalization or re-hospitalization for heart failure at 6 months after MI, large infarct defined as CK peak at 6 hours > 4500 UI/L] |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular death at 6 months. |  | 6 months | 
| Worsening of heart failure | Worsening of heart failure during initial hospitalization or re-hospitalization for heart failure at 6 months. | 6 months | 
| Time to first event [all-cause mortality; worsening of heart failure during initial hospitalization or re-hospitalization for heart failure] |  | 6 months | 
| Major Adverse Cardiac Events (MACE) | MACE at 6 months: [all-cause mortality; worsening of heart failure during initial hospitalization or re-hospitalization for heart failure; malignant ventricular arrhythmias; recurrent infarction; unstable angina; unplanned revascularization; stroke]. | 6 months | 
| Renal failure | Renal failure (+25% increase in serum creatinine at 6 months versus baseline). | 6 months | 
| Peak of creatine kinase |  | 4-6 hours post-PCI | 
| creatine kinase |  | 5 days | 
| Measure hsCRP |  | 5 days | 
| Rate of CRP |  | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ST-elevation myocardial infarction