Myocardial Infarction, Acute
Conditions
Keywords
ST-elevation myocardial infarction
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.
Interventions
DEVICERemote 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.
DEVICEPatients with no remote ischemic conditioning and no intracoronary ischemic conditioning
Brachial cuff is positioned during 40 minutes but not inflated. No intracoronary balloon inflation.
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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) | 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). |
| Peak of creatine kinase | 4-6 hours post-PCI | — |
| creatine kinase | 5 days | — |
| Measure hsCRP | 5 days | — |
| Rate of CRP | 5 days | — |
Countries
Belgium, France
Contacts
PRINCIPAL_INVESTIGATORGilles Rioufol, Pr
Hôpital Louis Pradel 28 avenue Doyen Lépine, BP Lyon-Montchat, 69394LYON cedex 03
Outcome results
None listed