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

NCT ID: NCT03155022

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 750 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-12
• Study Completion Date: 2023-10-03

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.

Conditions

Myocardial Infarction, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

RIC+ ICIC +

Patients with remote ischemic conditioning and intracoronary ischemic conditioning

Group Type: EXPERIMENTAL

Remote ischemic conditioning and intracoronary ischemic conditioning

Intervention Type: 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.

RCI - ICIC -

Control group with no remote ischemic conditioning and no intracoronary ischemic conditioning

Group Type: OTHER

Patients with no remote ischemic conditioning and no intracoronary ischemic conditioning

Intervention Type: DEVICE

Brachial cuff is positioned during 40 minutes but not inflated. No intracoronary balloon inflation.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilles Rioufol, Pr

Role: PRINCIPAL_INVESTIGATOR

Hôpital Louis Pradel 28 avenue Doyen Lépine, BP Lyon-Montchat, 69394LYON cedex 03

Locations

Algemeen Ziekenhuis Sint Jan

Bruges, , Belgium

CHU de Charleroi

Charleroi, , Belgium

Universitair Ziekenhuis Antwerpen

Edegem, , Belgium

Hopital Louis Pradel

Bron, , France

Countries

Belgium; France

Other Identifiers

2017-A01683-50

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL17_0032

Identifier Type: -

Identifier Source: org_study_id