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

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Other: Remote Ischemic Pre-Conditioning

• Registration Number: NCT02313441
• Lead Sponsor: Assiut University

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Primary Completion: 2014-05
• Study Completion: 2014-12
• Study First Submitted: 2014-12-07
• Study First Submitted QC: 2014-12-07
• Study First Posted: 2014-12-10
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-16
• Last Update Posted: 2019-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RIPC (Remote Ischemic Pre-Conditioning)	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
Control	Remote Ischemic Pre-Conditioning	Control participants did not experience this procedure of transient upper-limb ischemia.

Primary Outcome Measures

Name	Time	Method
Incidence of PCI- related myocardial infarction (MI 4a) at 24 hours after PCI.	24 hours	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.

Secondary Outcome Measures

Name	Time	Method
incidence of contrast induced nephropathy (CIN) at 72 hours after contrast exposure	72 hours	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.

Trial Locations

Locations (1)

Assiut University Hospitals; 🇪🇬 Assiut, Egypt