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NCT Number: NCT01558596

Remote Ischemic Preconditioning Prior to Vascular Surgery

The investigators have previously shown that elective vascular surgery is a high-risk operation with an anticipated risk of either death or heart attack of 15%. This study is testing whether a protocol of remote ischemic preconditioning (RIPC) applied 24 hours prior to the operation is safe, feasible and reduces the incidence of an adverse, perioperative cardiac complication.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases Vascular Surgery

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417, United States

About this study

The proposed investigation has a single blind, randomized design and plans to enroll 180-205 patients who are scheduled to have major, elective vascular surgery for occlusive carotid disease, expanding abdominal aortic aneurysm (AAA), occlusive lower extremity disease and/or critical limb ischemia at the Minneapolis VA Health Care Center. 24 hours prior to the patient's scheduled vascular operation, RIPC therapy will be applied to one of the participant's upper arms to cause forearm ischemia. Clinically collected, pre-operative troponins, creatine kinase MBs (CK-MBs), EKGs along with troponins, CK-MBs and EKGs collected on day 1, 2, 3 and day 7 (if still hospitalized) will be utilized to evaluate the occurrence of perioperative, adverse cardiac events.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Undergoing elective major vascular surgery at the Minneapolis VA Medical Center for abdominal aortic aneurysm, carotid disease or limb ischemia.
  • Age > 18.
  • Provides informed consent.

Exclusion criteria

  • Hypertensive crisis
  • Peripheral arterial disease of the upper extremities
  • Arteriovenous (AV) fistula
  • Acute Coronary Syndrome (ACS) in the last 6 months
  • Severe valvular heart disease
  • Pregnant women
  • Unable to provide consent

Treatment and study plan

Preconditioning

Procedure

Blood pressure cuff inflated to 200 mmHg in the upper extremity for 5 minutes to cause forearm ischemia by external compression of the brachial artery. This will be followed by 5 minutes of cuff deflation to allow for preperfusion. The ischemia-reperfusion cycle will be repeated 3 times for a total duration of 30 minutes, equally divided between ischemia and reperfusion.

Control

Procedure

Blood pressure cuff inflated to 40-50 mmHg in the upper extremity

Primary outcomes

  1. Troponin I Elevation Above the Upper Reference Limit (URL)

    Time frame: Within 3 days of the vascular operation

    Troponin I is a biomarker of myocardial necrosis that may indicate myocardial damage or injury that occurs during the perioperative period

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Cardiac Remote Ischemic Preconditioning Prior to Elective Major Vascular Surgery

Acronym: CRIPES

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Mar 20, 2012
Registry last updated
Mar 22, 2017

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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