NCT01403337

Cardiac Remote Ischemic Preconditioning Before Elective Major Vascular Surgery

Cardiac Remote Ischemic Preconditioning Before Elective Major Vascular Surgery (CRIPES)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: Center for Veterans Research and Education · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Vascular surgery is considered a high-risk operation with an anticipated risk of major cardiovascular complications in excess of 5%. The occurrence of a cardiovascular complication after surgery carries a long-term higher mortality risk. The main objective of this investigation is to reduce the proportion of patients having major cardiovascular complications during surgery through a clinical protocol of remote preconditioning that is safe, effective and reproducible.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
OTHER	Ischemic preconditioning	The RIPC protocol will consist of three cycles of the following: 5-minute inflation of a blood pressure cuff around the right upper arm to 200 mmHg (or 20 above the systolic blood pressure if baseline BP \> 200 mmHg) to allow for external compression of the brachial artery resulting in transient arm ischemia, followed by a 5-minute interval of cuff deflation to allow for reperfusion. The total duration of the protocol is 30 minutes equally divided between ischemia and reperfusion. The protocol is to be applied in the patient room the morning of the operation.
OTHER	Control	A Blood Pressure cuff inflated to 40-50 mmHg

Timeline

• Start date: 2011-07-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2011-07-27
• Last updated: 2016-03-16

Locations

1 site across 1 country: United States