Remote Ischemic Preconditioning in ad Hoc Percutaneous Coronary Interventions
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|ClinicalTrials.gov Identifier: NCT01158716|
Recruitment Status : Completed
First Posted : July 8, 2010
Results First Posted : April 9, 2014
Last Update Posted : April 9, 2014
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Other: Remote Ischemic Preconditioning||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||94 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Remote Ischemic Preconditioning in ad Hoc Percutaneous Coronary Interventions: a Randomized Clinical Study|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||June 2012|
|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|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01158716
|Athens, Attica, Greece, 11521|
|Study Chair:||Demosthenes G Katritsis, MD, PhD||Athens Euroclinic|