Single-cycle Remote Ischemic Preconditioning and Postconditioning (SCRIP) Trial

Phramongkutklao College of Medicine and Hospital

Status: Unknown

Conditions: Ischemic Reperfusion Injury

Treatments: Procedure: RIPost; Procedure: Sham-Post; Procedure: Sham-Pre; Procedure: RIPre

Study type: Interventional

Funder types: Other

Identifiers

NCT02649309

PMK-SCRIP

Details and patient eligibility

About

This trial is a 2 x 2 factorial design, double-blinded, randomized controlled trial to evaluate efficacy and safety of remote ischemic preconditioning and postconditioning in patient undergoing coronary angioplasty.

Enrollment: 370 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Eligible for percutaneous coronary intervention (elective and emergency cases)
• Age > 18-year-old
• Informed consent

Exclusion criteria

• Previous CABG
• Previous PCI in 1 week / treatment with thrombolysis within 30 days
• Peripheral arterial disease / A-V shunt of upper extremities (AVF for hemodialysis)
• Paresis of upper limb
• Unstable patient such as cardiogenic shock / vasopressor / IABP / cooling (hypothermia)
• Fatal cardiac arrhythmia (VT / VF)
• Chronic hypoxia

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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370 participants in 4 patient groups

RIPre + RIPost

Experimental group

Description:

Intervention: RIPre 200 mmHg + RIPost 200 mmHg

Treatment:

Procedure: RIPost

Procedure: RIPre

RIPre + Sham

Experimental group

Description:

Intervention: RIPre 200 mmHg + Sham 10 mmHg

Treatment:

Procedure: Sham-Post

Procedure: RIPre

Sham + RIPost

Experimental group

Description:

Intervention: Sham 10 mmHg + RIPost 200 mmHg

Treatment:

Procedure: RIPost

Procedure: Sham-Pre

Sham + Sham

Sham Comparator group

Description:

Intervention: Sham 10 mmHg + Sham 10 mmHg

Treatment:

Procedure: Sham-Pre

Procedure: Sham-Post