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

Study Overview
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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).

Official Title
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Cardio- and Reno-protective Effect of Remote Ischemic Preconditioning in Patients Undergoing Percutaneous Coronary Intervention. A Prospective, Non-randomized Controlled Trial.

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Other: Remote Ischemic Pre-Conditioning


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RIPC (Remote Ischemic Pre-Conditioning)<br>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 | Other: Remote Ischemic Pre-Conditioning<br>* 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<br>|
| Placebo Comparator: Control<br>Control participants did not experience this procedure of transient upper-limb ischemia. | Other: Remote Ischemic Pre-Conditioning<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of PCI- related myocardial infarction (MI 4a) at 24 hours after PCI. | PCI-related myocardial infarction (MI 4a) was defined as cardiac Troponin I (cTnI) elevation >0.20ng/mL (5 times the upper reference limit) 24 hr. post PCI. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of contrast induced nephropathy (CIN) at 72 hours after contrast exposure | CIN was defined as an increase in the serum creatinine level of more than 0.5 mg/dl or more than 25 % from baseline within 3 days after procedure without any other identifiable cause of acute kidney injury. | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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remote ischemic preconditioning