Cardio- and Renoprotective Effect of Remote Ischemic Preconditioning in Patients Undergoing Percutaneous Coronary Intervention

Assiut University

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Other: Remote Ischemic Pre-Conditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT02313441

RIPC1

Details and patient eligibility

About

Myocyte necrosis occurs frequently in elective percutanious percutaneous coronary intervention (PCI) and is associated with subsequent cardiovascular events. This study assessed the cardio- and reno-protective effect of remote ischemic preconditioning (RIPC) in patients undergoing elective PCI. 200 patients were randomized into 2 groups: 100 patients received RIPC (created by three 5-minute inflations of a blood pressure cuff to 200 mm Hg around the upper arm, separated by 5-minute intervals of reperfusion) < 2 hours before the PCI procedure, and the control group (n = 100).

Enrollment: 200 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients between 18 and 85 years of age,
• scheduled to undergo an elective PCI and
• able to give an informed consent were eligible for enrollment in the study.
• Elective PCI was defined as any coronary revascularization in a low-risk patient who presents to the facility for a planned PCI or for a coronary angiogram followed by ad hoc PCI.

Exclusion criteria

• (1) emergency PCI, (2) baseline troponin value ≥ 0.04 ng/mL, (3) nicorandil or glibenclamide use (preconditioning-mimetic and preconditioning-blocking medication, respectively), (4) those who could not give informed consent, and (5) patients with severe renal impairment or on regular dialysis.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups, including a placebo group

RIPC (Remote Ischemic Pre-Conditioning)

Active Comparator group

Description:

Patients used RIPC had a blood pressure cuff placed around their upper arm at \< 2 hours before the PCI procedure. The blood pressure cuff was inflated to for 5 minutes, followed by 5 minutes of deflation. This procedure was repeated 3 times

Treatment:

Other: Remote Ischemic Pre-Conditioning

Control

Placebo Comparator group

Description:

Control participants did not experience this procedure of transient upper-limb ischemia.

Treatment:

Other: Remote Ischemic Pre-Conditioning