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

Myocardial Infarction, Acute Clinical Trial

— CARIOCA  

Official title:

Combined Application of Remote and Intra-Coronary Ischemic Conditioning in Acute Myocardial Infarction: A Multicenter, Randomized, Controlled Clinical Trial (CARIOCA Study)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03155022
• Other study ID #: 69HCL17_0032
• Secondary ID: 2017-A01683-50
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 12, 2018
• Est. completion date: October 2023

Study information

• Verified date: June 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 750
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Myocardial Infarction, Acute

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
Belgium	Algemeen Ziekenhuis Sint Jan	Brugge
Belgium	CHU de Charleroi	Charleroi
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
France	Hopital Louis Pradel	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cardiovascular death at 6 months.		6 months
Secondary	Worsening of heart failure	Worsening of heart failure during initial hospitalization or re-hospitalization for heart failure at 6 months.	6 months
Secondary	Time to first event [all-cause mortality; worsening of heart failure during initial hospitalization or re-hospitalization for heart failure]		6 months
Secondary	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
Secondary	Renal failure	Renal failure (+25% increase in serum creatinine at 6 months versus baseline).	6 months
Secondary	Peak of creatine kinase		4-6 hours post-PCI
Secondary	creatine kinase		5 days
Secondary	Measure hsCRP		5 days
Secondary	Rate of CRP		5 days