Remote Ischemic Preconditioning in ad Hoc Percutaneous Coronary Interventions

Remote Ischemic Preconditioning in ad Hoc Percutaneous Coronary Interventions: a Randomized Clinical Study

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Other: Remote Ischemic Preconditioning

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 Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Attica
    • Athens, Attica, Greece, 11521
      • Athens Euroclinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control
ACTIVE_COMPARATOR: Remote Ischemic Preconditioning	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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cardiovascular Research Society, Greece
• Investigators: Study Chair: Demosthenes G Katritsis, MD, PhD, Athens Euroclinic

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (ACTUAL): May 1, 2012
• Study Completion (ACTUAL): June 1, 2012

Study Registration Dates

• First Submitted: July 7, 2010
• First Submitted That Met QC Criteria: July 7, 2010
• First Posted (ESTIMATE): July 8, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): April 9, 2014
• Last Update Submitted That Met QC Criteria: March 1, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; remote ischemic preconditioning
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 4.7.7.2010