Cardiac Remote Ischemic Preconditioning Before Elective Major Vascular Surgery

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Minneapolis VA Medical Center

Minneapolis, Minnesota, 55417, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Eligible patients would be those undergoing elective major vascular surgery at the Minneapolis VA Medical Center for an expanding abdominal aortic aneurysm, obstructive carotid disease, and/or chronic limb ischemia during the study period. All patients must be ≥ 18 years of age and provide written informed consent.

Exclusion criteria

Exclusion criteria include hypertensive crisis, acute coronary syndrome in the preceding 6 weeks, severe valvular heart disease, peripheral arterial disease of the upper extremities, manifested by a systolic blood pressure difference greater than 20 mmHg, pregnant women, patients unable to understand the consent process due to mental illness, advanced malignancy with limited life expectancy (<1 year), and hemodialysis with a fistula in the upper extremity.

Treatment and study plan

Ischemic Preconditioning

Other

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.

Control

Other

A Blood Pressure cuff inflated to 40-50 mmHg

Primary outcomes

Troponin I elevation above the URL

Time frame: Within 1 week after surgery

Sponsors and collaborators

Lead sponsor

Center for Veterans Research and Education

Other

Registry information

Official study title

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

Acronym: CRIPES

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2015
First posted: Jul 27, 2011
Registry last updated: Mar 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed