NCT03233919

COmprehensive Remote Ischemic Conditioning in Myocardial Infarction

Evaluation of Comprehensive Remote Ischemic Conditioning in ST-elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the CORIC-MI trial is to evaluate whether comprehensive (per, post plus delayed) remote ischemic conditioning (CORIC) as an adjunctive therapy in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI) can improve left ventricular function and remodeling at 30 days assessed by cardiac magnetic resonance imaging (CMR) for a minimum follow-up period of 12 months.

Detailed description

ST-segment elevation myocardial infarction (STEMI) is a leading cause of mortality and morbidity worldwide. Rapid admission and acute interventional treatment combined with modern antithrombotic pharmacologic therapy frequently establish complete reperfusion and acutely stabilize the patient, but the reperfusion itself adds further to the damage in the myocardium compromising the long-term outcome. At present, remote ischemic conditioning (RIC) is the most promising adjuvant therapy to reduce reperfusion injury in patients with STEMI. However, myocardial remodeling continues for several weeks after a myocardial infarction. Recent animal studies have shown that RIC may also help the heart muscle recover if applied every day during the month after a heart attack. The CORIC-MI trial is a single-center, randomized, controlled, parallel group, and open-label trial, with blinded evaluation of the endpoints.The primary objective of the trial is to evaluate whether comprehensive (per, post plus delayed) remote ischemic conditioning (CORIC) as an adjunctive therapy in patients with STEMI undergoing primary percutaneous coronary intervention (PPCI) can improve left ventricular function and remodeling at 30 days assessed by cardiac magnetic resonance imaging (CMR) for a minimum follow-up period of 12 months.

Conditions

• Myocardial Infarction, Anterior Wall

Interventions

Type	Name	Description
DEVICE	comprehensive remote ischaemic conditioning	comprehensive remote ischaemic conditioning will be induced using an automated RIC device: Per-RIC consists of 5 cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on a lower limb. The first inflation began immediately following randomization after admission. In case 5 cycles of RIC were not fully completed when the first balloon inflation or thrombus aspiration was ready to be performed, PCI was not to be delayed. Post-RIC consists of 5 cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on a lower limb immediately after PPCI. Delayed-RIC consists of 5 cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on a lower limb once daily on 2-28 days after MI.

Timeline

• Start date: 2017-08-01
• Primary completion: 2019-01-30
• Completion: 2020-01-30
• First posted: 2017-07-31
• Last updated: 2018-04-24

Locations

1 site across 1 country: China