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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A01683-50 | Other Identifier | IDRCB |
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lack of recruitment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIC+ ICIC + | Experimental | Patients with remote ischemic conditioning and intracoronary ischemic conditioning |
|
| RCI - ICIC - | Other | Control group with no remote ischemic conditioning and no intracoronary ischemic conditioning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote ischemic conditioning and intracoronary ischemic conditioning | Device | 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. |
| Measure | Description | 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 |
| 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 |
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Inclusion Criteria:
Non inclusion Criteria:
Exclusion Criteria:
Patients with main occlusion localized on :
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| Name | Affiliation | Role |
|---|---|---|
| Gilles Rioufol, Pr | Hôpital Louis Pradel 28 avenue Doyen Lépine, BP Lyon-Montchat, 69394LYON cedex 03 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Algemeen Ziekenhuis Sint Jan | Bruges | Belgium | ||||
| CHU de Charleroi |
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| Patients with no remote ischemic conditioning and no intracoronary ischemic conditioning | Device | Brachial cuff is positioned during 40 minutes but not inflated. No intracoronary balloon inflation. |
|
| 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) | 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 |
| creatine kinase | 5 days |
| Measure hsCRP | 5 days |
| Rate of CRP | 5 days |
| Charleroi |
| Belgium |
| Universitair Ziekenhuis Antwerpen | Edegem | Belgium |
| Hopital Louis Pradel | Bron | France |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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