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

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ClinicalTrials.gov Identifier: NCT03155022
Recruitment Status : Recruiting
First Posted : May 16, 2017
Last Update Posted : January 21, 2022
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction, Acute Device: Remote ischemic conditioning and intracoronary ischemic conditioning Device: Patients with no remote ischemic conditioning and no intracoronary ischemic conditioning Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 710 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combined Application of Remote and Intra-Coronary Ischemic Conditioning in Acute Myocardial Infarction: A Multicenter, Randomized, Controlled Clinical Trial (CARIOCA Study)
Actual Study Start Date : April 12, 2018
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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] [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Cardiovascular death at 6 months. [ Time Frame: 6 months ]
  2. Worsening of heart failure [ Time Frame: 6 months ]
    Worsening of heart failure during initial hospitalization or re-hospitalization for heart failure at 6 months.

  3. Major Adverse Cardiac Events (MACE) [ Time Frame: 6 months ]
    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].

  4. Renal failure [ Time Frame: 6 months ]
    Renal failure (+25% increase in serum creatinine at 6 months versus baseline).

  5. Measure NTproBNP > 1800pg/m/L [ Time Frame: 48 hours post MI ]
  6. Measure NTproBNP [ Time Frame: 6 months ]
  7. Peak of creatine kinase [ Time Frame: 4-6 hours post-PCI ]
  8. Post-reperfusion malignant ventricular arrhythmias (VF, VT) [ Time Frame: 3 months after MI. ]
  9. Measure hsCRP [ Time Frame: 5 days ]
  10. Rate of CRP [ Time Frame: 5 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03155022


Contacts
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Contact: Gilles Rioufol, Pr 472357421 ext +33 gilles.rioufol@chu-lyon.fr
Contact: Naoual EL JONHY 472356912 ext +3333 naoual.el-jonhy@chu-lyon.fr

Locations
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Belgium
Algemeen Ziekenhuis Sint Jan Not yet recruiting
Brugge, Belgium
Contact: Patrick COUSSEMENT         
Principal Investigator: Patrick COUSSEMENT         
CHU de Charleroi Not yet recruiting
Charleroi, Belgium
Contact: Philippe DUBOIS         
Principal Investigator: Philippe DUBOIS         
Universitair Ziekenhuis Antwerpen Recruiting
Edegem, Belgium
Contact: Marc CLAEYS         
Principal Investigator: Marc CLAEYS         
France
Hopital Louis Pradel Recruiting
Bron, France
Contact: Gilles Rioufol, Pr         
Principal Investigator: Gilles Rioufol         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Gilles Rioufol, Pr Hôpital Louis Pradel 28 avenue Doyen Lépine, BP Lyon-Montchat, 69394LYON cedex 03
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03155022    
Other Study ID Numbers: 69HCL17_0032
2017-A01683-50 ( Other Identifier: IDRCB )
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: January 21, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
ST-elevation myocardial infarction
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases