Remote Ischemic Preconditioning in ad Hoc Percutaneous Coronary Interventions

Overview

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.

Full Title of Study: “Remote Ischemic Preconditioning in ad Hoc Percutaneous Coronary Interventions: a Randomized Clinical Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: May 2012

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.

Interventions

  • Other: Remote Ischemic Preconditioning
    • Patients are subjected to a 5-minute ischemia of the non-dominant arm with the use of a blood pressure cuff (inflated at 200mm Hg)

Arms, Groups and Cohorts

  • Active Comparator: Remote Ischemic Preconditioning
  • No Intervention: Control

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Chest Pain During Coronary Balloon Occlusion
    • Time Frame: 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
    • Time Frame: During coronary balloon occlusion
    • ST-segment deviation as monitored during coronary balloon occlusion

Participating in This Clinical Trial

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%

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cardiovascular Research Society, Greece
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr D Katritsis, Head of Department of Cardiology, Athens Euroclinic – Cardiovascular Research Society, Greece
  • Overall Official(s)
    • Demosthenes G Katritsis, MD, PhD, Study Chair, Athens Euroclinic

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