Clinical trial NCT03155022: Combined Application of Remote and Intra-Coronary Ischemic Conditioning in Acute Myocardial Infarction
Official title: Combined Application of Remote and Intra-Coronary Ischemic Conditioning in Acute Myocardial Infarction: A Multicenter, Randomized, Controlled Clinical Trial (CARIOCA Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myocardial Infarction, Acute
Keywords: ST-elevation myocardial infarction
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-05-16
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

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).

Primary outcomes:
measure: 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]
timeFrame: 6 months
Secondary outcomes:
measure: Cardiovascular death at 6 months.
timeFrame: 6 months
measure: Worsening of heart failure
timeFrame: 6 months
measure: Time to first event [all-cause mortality; worsening of heart failure during initial hospitalization or re-hospitalization for heart failure]
timeFrame: 6 months
measure: Major Adverse Cardiac Events (MACE)
timeFrame: 6 months
measure: Renal failure
timeFrame: 6 months
measure: Peak of creatine kinase
timeFrame: 4-6 hours post-PCI
measure: creatine kinase
timeFrame: 5 days
measure: Measure hsCRP
timeFrame: 5 days
measure: Rate of CRP
timeFrame: 5 days
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: Algemeen Ziekenhuis Sint Jan
city: Charleroi
country: Belgium
facility: CHU de Charleroi
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Bron
country: France
facility: Hopital Louis Pradel
Study officials:
affiliation: Hôpital Louis Pradel 28 avenue Doyen Lépine, BP Lyon-Montchat, 69394LYON cedex 03
name: Gilles Rioufol, Pr
role: PRINCIPAL_INVESTIGATOR
References: