Cardiac Remote Ischemic Preconditioning Before Elective Major Vascular Surgery - Full Text View

Sponsor:	Minnesota Veterans Research Institute
Information provided by:	Minnesota Veterans Research Institute
ClinicalTrials.gov Identifier:	NCT01403337

Purpose

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.

Condition	Intervention	Phase
Peripheral Arterial Disease	Other: Ischemic preconditioning Other: Control	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Cardiac Remote Ischemic Preconditioning Before Elective Major Vascular Surgery (CRIPES)

Resource links provided by NLM:

MedlinePlus related topics: Peripheral Arterial Disease

U.S. FDA Resources

Further study details as provided by Minnesota Veterans Research Institute:

Primary Outcome Measures:

Troponin I elevation above the URL [ Time Frame: Within 1 week after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	July 2011
Estimated Study Completion Date:	July 2015
Estimated Primary Completion Date:	July 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Control Blood pressure cuff inflated in the right or left arm to 40-50 mmHg	Other: Control A Blood Pressure cuff inflated to 40-50 mmHg
Active Comparator: 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: 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.

Arms

Assigned Interventions

Placebo Comparator: Control

Blood pressure cuff inflated in the right or left arm to 40-50 mmHg

Other: Control

A Blood Pressure cuff inflated to 40-50 mmHg

Active Comparator: 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: 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01403337

Contacts

Contact: Stacy McNabb, RN

6124675977

Stacy.McNabb@va.gov

Locations

United States, Minnesota
Minneapolis VA Medical Center	Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Stacy McNabb, RN 612-467-5977 Stacy.McNabb@va.gov
Principal Investigator: Santiago Garcia, MD

Sponsors and Collaborators

Minnesota Veterans Research Institute

Investigators

Principal Investigator:

Santiago A Garcia, MD

Minneapolis VA Medical Center and The University of Minnesota

More Information

No publications provided

Responsible Party:	Santiago Garcia, MD, Minneapolis VA Medical Center
ClinicalTrials.gov Identifier:	NCT01403337 History of Changes
Other Study ID Numbers:	411652941
Study First Received:	July 26, 2011
Last Updated:	July 26, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Minnesota Veterans Research Institute:

peripheral arterial disease
myocardial infarction

Additional relevant MeSH terms:

Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis

Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2012