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

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

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.

Study Overview

• Status: Terminated
• Conditions: Myocardial Infarction, Acute
• Intervention / Treatment: Device: Remote ischemic conditioning and intracoronary ischemic conditioning; Device: Patients with no remote ischemic conditioning and no intracoronary ischemic conditioning

• Study Type: Interventional
• Enrollment (Actual): 750
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Bruges, Belgium
    • Algemeen Ziekenhuis Sint Jan
  • Charleroi, Belgium
    • CHU de Charleroi
  • Edegem, Belgium
    • Universitair Ziekenhuis Antwerpen
• France
  • Bron, France
    • Hôpital Louis Pradel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RIC+ ICIC +; Patients with remote ischemic conditioning and intracoronary ischemic conditioning	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.
Other: RCI - ICIC -; Control group with no remote ischemic conditioning and no intracoronary ischemic conditioning	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
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
Measure hsCRP		5 days
Rate of CRP		5 days
Time to first event [all-cause mortality; worsening of heart failure during initial hospitalization or re-hospitalization for heart failure]		6 months
creatine kinase		5 days

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Gilles Rioufol, Pr, Hôpital Louis Pradel 28 avenue Doyen Lépine, BP Lyon-Montchat, 69394LYON cedex 03

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2018
• Primary Completion (Actual): October 3, 2023
• Study Completion (Actual): October 3, 2023

Study Registration Dates

• First Submitted: May 11, 2017
• First Submitted That Met QC Criteria: May 15, 2017
• First Posted (Actual): May 16, 2017

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: ST-elevation myocardial infarction
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; ST Elevation Myocardial Infarction; Myocardial Infarction
• Other Study ID Numbers: 69HCL17_0032; 2017-A01683-50 (Other Identifier: IDRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No