Remote Ischemic Preconditioning in ad Hoc Percutaneous Coronary Interventions

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Other: Remote Ischemic Preconditioning


Participation Criteria
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Eligibility Criteria
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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%

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Remote Ischemic Preconditioning<br> | Other: Remote Ischemic Preconditioning<br>* 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)<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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percutaneous coronary intervention, remote ischemic preconditioning