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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01403337
First Posted: July 27, 2011
Last Update Posted: March 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Santiago Garcia, Minneapolis Veterans Affairs Medical Center
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Cardiac Remote Ischemic Preconditioning Before Elective Major Vascular Surgery (CRIPES)

Resource links provided by NLM:


Further study details as provided by Santiago Garcia, Minneapolis Veterans Affairs Medical Center:

Primary Outcome Measures:
  • Troponin I elevation above the URL [ Time Frame: Within 1 week after surgery ]

Enrollment: 205
Study Start Date: July 2011
Study Completion Date: September 2015
Primary Completion Date: September 2015 (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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01403337


Locations
United States, Minnesota
Minneapolis VA Medical Center
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
Minnesota Veterans Medical Research and Education Foundation
Investigators
Principal Investigator: Santiago A Garcia, MD Minneapolis VA Medical Center and The University of Minnesota
  More Information

Responsible Party: Santiago Garcia, Staff Cardiologist, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT01403337     History of Changes
Other Study ID Numbers: 411652941
First Submitted: July 26, 2011
First Posted: July 27, 2011
Last Update Posted: March 16, 2016
Last Verified: March 2016

Keywords provided by Santiago Garcia, Minneapolis Veterans Affairs Medical Center:
peripheral arterial disease
myocardial infarction

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases