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

Not Applicable

Active, not recruiting

• Conditions: Myocardial Infarction, Acute
• Interventions: Device: Remote ischemic conditioning and intracoronary ischemic conditioning; Device: Patients with no remote ischemic conditioning and no intracoronary ischemic conditioning

• Registration Number: NCT03155022
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-11
• Study First Submitted QC: 2017-05-15
• Study First Posted: 2017-05-16
• Study Start: 2018-04-12
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-22
• Last Update Posted: 2023-06-26
• Primary Completion: 2023-10
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 750

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RIC+ ICIC +	Remote ischemic conditioning and intracoronary ischemic conditioning	Patients with remote ischemic conditioning and intracoronary ischemic conditioning
RCI - ICIC -	Patients with no remote ischemic conditioning and no intracoronary ischemic conditioning	Control group with no remote ischemic conditioning and no intracoronary ischemic conditioning

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
creatine kinase	5 days
Measure hsCRP	5 days
Worsening of heart failure	6 months	Worsening of heart failure during initial hospitalization or re-hospitalization for heart failure at 6 months.
Cardiovascular death at 6 months.	6 months
Time to first event [all-cause mortality; worsening of heart failure during initial hospitalization or re-hospitalization for heart failure]	6 months
Rate of CRP	5 days
Peak of creatine kinase	4-6 hours post-PCI
Renal failure	6 months	Renal failure (+25% increase in serum creatinine at 6 months versus baseline).
Major Adverse Cardiac Events (MACE)	6 months	MACE at 6 months: \[all-cause mortality; worsening of heart failure during initial hospitalization or re-hospitalization for heart failure; malignant ventricular arrhythmias; recurrent infarction; unstable angina; unplanned revascularization; stroke\].

Trial Locations

Locations (4)

CHU de Charleroi; 🇧🇪 Charleroi, Belgium

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Belgium

Algemeen Ziekenhuis Sint Jan; 🇧🇪 Brugge, Belgium

Hopital Louis Pradel; 🇫🇷 Bron, France