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
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|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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||710 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- 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 ]
- Cardiovascular death at 6 months. [ Time Frame: 6 months ]
- Worsening of heart failure [ Time Frame: 6 months ]Worsening of heart failure during initial hospitalization or re-hospitalization for heart failure at 6 months.
- 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].
- Renal failure [ Time Frame: 6 months ]Renal failure (+25% increase in serum creatinine at 6 months versus baseline).
- Measure NTproBNP > 1800pg/m/L [ Time Frame: 48 hours post MI ]
- Measure NTproBNP [ Time Frame: 6 months ]
- Peak of creatine kinase [ Time Frame: 4-6 hours post-PCI ]
- Post-reperfusion malignant ventricular arrhythmias (VF, VT) [ Time Frame: 3 months after MI. ]
- Measure hsCRP [ Time Frame: 5 days ]
- Rate of CRP [ Time Frame: 5 days ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
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).
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
|Contact: Gilles Rioufol, Pr||472357421 ext +email@example.com|
|Contact: Naoual EL JONHY||472356912 ext +firstname.lastname@example.org|
|Algemeen Ziekenhuis Sint Jan||Not yet recruiting|
|Contact: Patrick COUSSEMENT|
|Principal Investigator: Patrick COUSSEMENT|
|CHU de Charleroi||Not yet recruiting|
|Contact: Philippe DUBOIS|
|Principal Investigator: Philippe DUBOIS|
|Universitair Ziekenhuis Antwerpen||Recruiting|
|Contact: Marc CLAEYS|
|Principal Investigator: Marc CLAEYS|
|Hopital Louis Pradel||Recruiting|
|Contact: Gilles Rioufol, Pr|
|Principal Investigator: Gilles Rioufol|
|Principal Investigator:||Gilles Rioufol, Pr||Hôpital Louis Pradel 28 avenue Doyen Lépine, BP Lyon-Montchat, 69394LYON cedex 03|
|Responsible Party:||Hospices Civils de Lyon|
|Other Study ID Numbers:||
2017-A01683-50 ( Other Identifier: IDRCB )
|First Posted:||May 16, 2017 Key Record Dates|
|Last Update Posted:||January 21, 2022|
|Last Verified:||January 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
ST-elevation myocardial infarction