Cardiac Remote Ischemic Preconditioning Before Elective Major Vascular Surgery

NCT01403337 | Completed Phase 1 DMC

• 1 other identifier: 411652941
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

peripheral arterial disease; myocardial infarction

Outcome Measures

Primary Outcomes (1)

• Troponin I elevation above the URL

  Within 1 week after surgery

Study Arms (2)

Control

PLACEBO COMPARATOR

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

Other: Control

Preconditioning

ACTIVE COMPARATOR

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

Interventions

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.

Preconditioning

Control OTHER

A Blood Pressure cuff inflated to 40-50 mmHg

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Center for Veterans Research and Education: lead

Study Sites (1)

Minneapolis VA Medical Center

Minneapolis, Minnesota, 55417, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Myocardial Infarction

Interventions

Ischemic Preconditioning

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Study Officials

• Santiago A Garcia, MD

  Minneapolis VA Medical Center and The University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Cardiologist

Study Record Dates

• First Submitted: July 26, 2011
• First Posted: July 27, 2011
• Study Start: July 1, 2011
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: March 16, 2016

Record last verified: 2016-03

Locations

US (1)