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Main Research Questions:
2. What regimen (i.e. how many times and in which limb) provides the best protection?
What is Being Studied:
A simple procedure known as remote ischemic preconditioning. The procedure is performed by inflating a pressurized cuff around either the arm and/or the thigh to temporarily stop blood flow to the arm or leg. This procedure causes the body to have a stress response that, at the cellular level, may protect major organs like the heart and kidney from the damage caused to them by cardiac surgery. Reducing this damage may improve patient's recovery after surgery and help them live longer.
Why is this study important?:
This research is important because 1 in every 20 patients that undergo heart surgery die before even leaving hospital. Preventing heart and kidney damage at the time of surgery with remote ischemic preconditioning may reduce patient deaths.
Annually, 2 million patients worldwide undergo heart surgery. Although this procedure can prolong life, 1 in 20 patients will not survive their hospital stay. Acute heart and kidney injuries are important causes of death after heart surgery. Remote ischemic preconditioning (RIPC) is a promising and simple therapy that may simultaneously reduce heart and kidney damage. RIPC involves the inflation of a tourniquet or blood pressure cuff on a limb to briefly stop blood flow to that limb. This period of no blood flow activates the body's own protective systems and releases protective chemicals into the blood that also protect the heart and kidneys. RIPC is a particularly attractive potential treatment because it may impact several organs at once, it has no known adverse effects and costs almost nothing. RIPC could therefore very easily be used globally to improve outcomes for all patients undergoing heart surgery. Although RIPC appears very promising in several small studies using different RIPC regimens there are no studies large enough to definitively evaluate whether RIPC improves patient important outcomes (e.g. survival). Before performing a large trial that determines whether RIPC improves patient-important outcomes, the optimal regimen of RIPC must be identified. We will determine the effect of RIPC on heart and kidney injury and determine what regimen of RIPC is most effective in our pilot randomized control trial. This trial will enroll 700 patients in 6 different RIPC regimens and compare them to a group that receives only a sham procedure (i.e. no real RIPC). We call this trial the Remote IscheMia Preconditioning in cArdiaC surgery Trial (Remote IMPACT).
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Remote Ischemic Preconditioning, Sham
Not yet recruiting
Published on BioPortfolio: 2014-07-23T21:10:24-0400
The purpose of this study is to evaluate the effects of Remote Ischemic Preconditioning on cardiac function in patients undergoing cardiac surgery compared to control intervention.
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The application of repeated, brief periods of vascular occlusion at the onset of REPERFUSION to reduce REPERFUSION INJURY that follows a prolonged ischemic event. The techniques are similar to ISCHEMIC PRECONDITIONING but the time of application is after the ischemic event instead of before.
A technique in which tissue is rendered resistant to the deleterious effects of prolonged ischemia and reperfusion by prior exposure to brief, repeated periods of vascular occlusion. (Am J Physiol 1995 May;268(5 Pt 2):H2063-7, Abstract)
Procedures that avoid use of open invasive surgery in favor of closed or local surgery. These generally involve use of laparoscopic devices and remote-control manipulation of instruments with indirect observation of the surgical field through an endoscope or similar device. With the reduced trauma associated with minimally invasive surgery, long hospital stays may be reduced with increased rates of short stay or day surgery.
Consultation via remote telecommunications, generally for the purpose of diagnosis or treatment of a patient at a site remote from the patient or primary physician.
Procedures that avoid use of open, invasive surgery in favor of closed or local surgery. These generally involve use of laparoscopic devices and remote-controlled manipulation of instruments with indirect observation of the surgical field through an endoscope or similar device.
Cardiovascular disease (CVD)
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Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...
Cardiology is a specialty of internal medicine. Cardiac electrophysiology : Study of the electrical properties and conduction diseases of the heart. Echocardiography : The use of ultrasound to study the mechanical function/physics of the h...