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

NCT03155022 | Completed DMC

• 2 other identifiers: 69HCL17_00322017-A01683-50
• Study Type: interventional
• Target: 750
• Locations: 2 countries
• Sites: 4

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

Keywords

ST-elevation myocardial infarction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Cardiovascular death at 6 months.

  6 months

• Worsening of heart failure

  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

• Renal failure

  6 months

Study Arms (2)

RIC+ ICIC +

EXPERIMENTAL

Patients with remote ischemic conditioning and intracoronary ischemic conditioning

Device: Remote ischemic conditioning and intracoronary ischemic conditioning

RCI - ICIC -

OTHER

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

Device: Patients with no remote ischemic conditioning and no intracoronary ischemic conditioning

Interventions

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.

RIC+ ICIC +

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.

RCI - ICIC -

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (4)

Algemeen Ziekenhuis Sint Jan

Bruges, Belgium

Location

CHU de Charleroi

Charleroi, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, Belgium

Location

Hopital Louis Pradel

Bron, France

Location

MeSH Terms

Conditions

Myocardial Infarction; ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Gilles Rioufol, Pr

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: May 16, 2017
• Study Start: April 12, 2018
• Primary Completion: October 3, 2023
• Study Completion: October 3, 2023
• Last Updated: August 28, 2025

Record last verified: 2025-08

Locations

FR (1); BE (3)