Remote Ischemic Preconditioning in ad Hoc Percutaneous Coronary Interventions

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Other: Remote Ischemic Preconditioning

• Registration Number: NCT01158716
• Lead Sponsor: Cardiovascular Research Society, Greece

Brief Summary

Elective percutaneous coronary intervention (PCI) is associated with troponin release in approximately one third of cases. Myocardial necrosis may result from downstream embolization of atheromatous material, coronary side-branch occlusion and may involve ischemia/reperfusion injury. The investigators hypothesized that a single remote ischemic preconditioning cycle would reduce peri-procedural troponin release.

Detailed Description

Elective percutaneous coronary intervention (PCI) is associated with troponin release in approximately one third of cases, which is a sensitive and specific marker of myocyte necrosis. Myocardial necrosis may result from downstream embolization of atheromatous material, coronary side-branch occlusion and may involve ischemia/reperfusion injury. A number of studies have demonstrated that procedure-related troponin release is associated with subsequent cardiovascular events and a worst prognosis, especially in those patients with the most marked elevation in troponin concentration.

Recently, 3 cycles of 5-minute ischemia followed by 5-minute reperfusion of the upper extremities were shown to reduce troponin release in elective PCI. However, this ischemic preconditioning (IPC) protocol requires 30 minutes and is of limited use in the context of PCI at the time of initial cardiac catheterization (ad hoc coronary intervention).

Since experimental evidence suggests that IPC is a graded than an "all-or-nothing" phenomenon, and even a short, single IPC cycle may have protective effects in the myocardium, the investigators hypothesized that patients undergoing ad hoc coronary intervention would have reduced peri-procedural troponin release if subjected to a single, remote IPC cycle, between diagnostic catheterization and coronary intervention.

Study Timeline

• Study First Submitted: 2010-07-07
• Study First Submitted QC: 2010-07-07
• Study First Posted: 2010-07-08
• Study Start: 2011-07
• Primary Completion: 2012-05
• Study Completion: 2012-06
• Status Verified: 2014-03
• Results First Submitted: 2014-03-01
• Results First Submitted QC: 2014-03-01
• Last Update Submitted: 2014-03-01
• Results First Posted: 2014-04-09
• Last Update Posted: 2014-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

• Patients with a significant stenosis as documented in coronary angiography eligible for PCI
• Patients ≥ 18 of age and able to give informed consent

Exclusion Criteria

• Severe comorbidity (estimated life expectancy <6 months)
• Use of nicorandil or glibenclamide
• Elevated baseline cTnI before PCI
• Renal disease as documented by serum creatinine before PCI
• LVEF<35%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remote Ischemic Preconditioning	Remote Ischemic Preconditioning	-

Primary Outcome Measures

Name	Time	Method
Delta Cardiac Troponin I (ΔcTnI)	24 hours post PCI	ΔcTnI is defined as cardiac troponin I (cTnI) at 24 hours post-PCI minus cTnI before coronary angiography

Secondary Outcome Measures

Name	Time	Method
Chest Pain During Coronary Balloon Occlusion	During coronary balloon occlusion	Chest pain severity was assessed with a 10 point scale (0: no pain, 10: most severe discomfort ever experienced)
ECG Evidence of Ischemia During Coronary Balloon Occlusion	During coronary balloon occlusion	ST-segment deviation as monitored during coronary balloon occlusion

Trial Locations

Locations (1)

Athens Euroclinic; 🇬🇷 Athens, Attica, Greece