CARIOCA: Combined Application of Remote and Intra-Coronary Ischemic Conditioning in Acute Myocardial Infarction
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- 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
- Cardiovascular death at 6 months. [6 months]
- Worsening of heart failure [6 months]
Worsening of heart failure during initial hospitalization or re-hospitalization for heart failure at 6 months.
- Major Adverse Cardiac Events (MACE) [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 [6 months]
Renal failure (+25% increase in serum creatinine at 6 months versus baseline).
- Measure NTproBNP > 1800pg/m/L [48 hours post MI]
- Measure NTproBNP [6 months]
- Peak of creatine kinase [4-6 hours post-PCI]
- Post-reperfusion malignant ventricular arrhythmias (VF, VT) [3 months after MI.]
- Measure hsCRP [5 days]
- Rate of CRP [5 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
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All (male and female) patients, aged over 18,
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Presenting within 12 hours of the onset of chest pain,
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For whom the clinical decision was made to treat with percutaneous coronary intervention (PCI),
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ST segment elevation ≥ 0.2 mV in two contiguous ECG leads,
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Written informed consent obtained or oral informed consent certified by a third party.
Non inclusion Criteria:
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Patients with cardiogenic shock,
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Patients with uncontrolled (treated or untreated) hypertension (> 180/110 mmHg),
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Patients with loss of consciousness or confused,
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Patients without health coverage,
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Patient with any legal protection measure,
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Female patients currently pregnant (oral diagnosis) or women of childbearing age who were not using contraception.
Exclusion Criteria:
Patients with main occlusion localized on :
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LAD: distal or ostial segment,
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Non dominant RCA / CX: mid or distal segment,
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Dominant RCA / CX: distal segment,
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Algemeen Ziekenhuis Sint Jan | Brugge | Belgium | ||
| 2 | CHU de Charleroi | Charleroi | Belgium | ||
| 3 | Universitair Ziekenhuis Antwerpen | Edegem | Belgium | ||
| 4 | Hopital Louis Pradel | Bron | France |
Sponsors and Collaborators
- Hospices Civils de Lyon
Investigators
- Principal Investigator: Gilles Rioufol, Pr, Hôpital Louis Pradel 28 avenue Doyen Lépine, BP Lyon-Montchat, 69394LYON cedex 03
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 69HCL17_0032
- 2017-A01683-50