Remote Ischemic Preconditioning in ad Hoc Percutaneous Coronary Interventions
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Remote Ischemic Preconditioning in ad Hoc Percutaneous Coronary Interventions: a Randomized Clinical Study|
- Delta Cardiac Troponin I (ΔcTnI) [ Time Frame: 24 hours post PCI ] [ Designated as safety issue: Yes ]ΔcTnI is defined as cardiac troponin I (cTnI) at 24 hours post-PCI minus cTnI before coronary angiography
- Chest Pain During Coronary Balloon Occlusion [ Time Frame: During coronary balloon occlusion ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]ST-segment deviation as monitored during coronary balloon occlusion
|Study Start Date:||July 2011|
|Study Completion Date:||June 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
|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)
|No Intervention: Control|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01158716
|Athens, Attica, Greece, 11521|
|Study Chair:||Demosthenes G Katritsis, MD, PhD||Athens Euroclinic|