Remote Ischemic Preconditioning in ad Hoc Percutaneous Coronary Interventions
Recruitment status was Not yet recruiting
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 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|
- Cardiac troponin I at 24 hours post PCI [ Time Frame: 24 hours post PCI ] [ Designated as safety issue: Yes ]
- Major adverse cardiac events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||December 2010|
|Estimated Primary Completion Date:||November 2010 (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.
|Contact: Demosthenes G Katritsis, MD, PhDemail@example.com|
|Contact: Theodoros A Zografos, MDfirstname.lastname@example.org|
|Athens Euroclinic||Not yet recruiting|
|Athens, Attica, Greece, 11521|
|Contact: Demosthenes G Katritsis, MD, PhD email@example.com|
|Study Chair:||Demosthenes G Katritsis, MD, PhD||Athens Euroclinic|