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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-12-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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RIPC (Remote Ischemic Pre-Conditioning)

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

Group Type ACTIVE_COMPARATOR

Remote Ischemic Pre-Conditioning

Intervention Type OTHER

The blood pressure cuff was inflated to a pressure of 200 mm Hg for 5 minutes, followed by 5 minutes of deflation to allow reperfusion. This procedure was repeated 3 times by the resident doctors in the pre-cath room

Control

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

Group Type PLACEBO_COMPARATOR

Remote Ischemic Pre-Conditioning

Intervention Type OTHER

The blood pressure cuff was inflated to a pressure of 200 mm Hg for 5 minutes, followed by 5 minutes of deflation to allow reperfusion. This procedure was repeated 3 times by the resident doctors in the pre-cath room

Interventions

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Remote Ischemic Pre-Conditioning

The blood pressure cuff was inflated to a pressure of 200 mm Hg for 5 minutes, followed by 5 minutes of deflation to allow reperfusion. This procedure was repeated 3 times by the resident doctors in the pre-cath room

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No