Effect of Remote Ischaemic Conditioning on Clinical Outcomes in STEMI Patients Undergoing PPCI (CONDI2/ERIC-PPCI)

University College London (UCL)

Status: Completed

Conditions: Myocardial Reperfusion Injury; STEMI

Treatments: Device: Remote ischemic conditioning; Device: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT02342522

CS/14/3/31002

Details and patient eligibility

About

The purpose of this study is to determine whether remote ischemic conditioning can reduce cardiac death and hospitalization for heart failure at 12 months in patients presenting with a ST-elevation myocardial infarction and treated by percutaneous coronary intervention.

Full description

The CONDI2/ERIC-PPCI trial is a randomised controlled clinical trial investigating whether remote ischemic conditioning (RIC) can reduce cardiac death and hospitalization for heart failure at 12 months in 5400 patients presenting with a ST-elevation myocardial infarction (STEMI) and treated by percutaneous coronary intervention (PPCI).

Enrollment: 5,413 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Onset of STEMI symptoms within 12 hours, lasting for more than 30 minutes
2. Patients older than 18 years
3. Suspected STEMI (ST-elevation at the J-point in two contiguous leads with the cutoff points: ≥0.2 millivolt (mV) in men or ≥0.15 mV in women in leads V2-V3 and/or ≥0.1 mV in other leads)

Exclusion criteria

1. Previous coronary artery bypass graft surgery
2. Myocardial infarction within the previous 30 days
3. Treatment with thrombolysis within the previous 30 days
4. Left bundle branch block
5. Patients treated with therapeutic hypothermia
6. Conditions precluding use of RIC (paresis of upper limb, use of an a-v shunt)
7. Life expectancy of less than 1 year due to non-cardiac pathology

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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5,413 participants in 2 patient groups

Remote ischemic conditioning

Active Comparator group

Description:

AutoRIC device will be placed on the upper arm and an active RIC protocol will be delivered (4x5 min cycles of inflation to 200mmHg and deflation) prior to PPCI.

Treatment:

Device: Remote ischemic conditioning

Sham control

Sham Comparator group

Description:

Sham AutoRIC device will be placed on the upper arm and a sham RIC protocol will be delivered prior to PPCI.

Treatment:

Device: Control