Protection of the Heart With Remote Ischemic Preconditioning During Heart Surgery: A Pilot Study

NCT00546390 | Completed Results

• 1 other identifier: Protect
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare a treatment called remote ischemic preconditioning (rIP) to no treatment. rIP is a simple treatment that is believed to help patients recover better after heart surgery. This treatment involves applying a large blood pressure cuff to one leg. The blood pressure cuffs will be inflated for 5 minutes and then deflated for 5 minutes. This will be done 4 times in a row.

Conditions

Remote Ischemic Preconditioning; Myocardial Protection

Outcome Measures

Primary Outcomes (1)

• Myocardial Protection Against Ischemic Injury

  High-sensitivity cardiac troponin T release as measured by peak hscTnT values and area-under-the-curve.

  72 hours post operatively

Secondary Outcomes (1)

• All-cause Death and Cardiovascular Long-term Outcome

  6-month cardiovascular outcome

Study Arms (2)

Ischemic Preconditioned Group (rIP)

EXPERIMENTAL

A 15-cm sterile blood pressure cuff was placed around the right thigh and connected to the inflating device, and the patient was draped obscuring the visibility of the cuff. Subsequently, the patient was randomly allocated (by opening of an envelope) to RIPC consisting of four 5-min cycles of lower limb ischemia-reperfusion induced by a tourniquet inflated to 300 mmHg

Device: Blood Pressure Cuff

No Cuff

NO INTERVENTION

No rIP

Interventions

Blood Pressure Cuff DEVICE

The blood pressure cuff will be inflated for 5 minutes and then deflated for 5 minutes. This will be done 4 times in a row.

Ischemic Preconditioned Group (rIP)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Age 18 through 80 years, inclusive
• Scheduled for heart surgery with CPB

You may not qualify if:

• Females of childbearing potential
• Emergency surgery
• Previous sternotomy
• Myocardial infarction within 48 hours prior to surgery
• Diabetes and/or BMI \>35
• Need for Alpha2-agonists perioperatively
• Peripheral Vascular Disease

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2G3, Canada

Location

Related Publications (1)

• Lucchinetti E, Bestmann L, Feng J, Freidank H, Clanachan AS, Finegan BA, Zaugg M. Remote ischemic preconditioning applied during isoflurane inhalation provides no benefit to the myocardium of patients undergoing on-pump coronary artery bypass graft surgery: lack of synergy or evidence of antagonism in cardioprotection? Anesthesiology. 2012 Feb;116(2):296-310. doi: 10.1097/ALN.0b013e318242349a.

  PMID: 22222469 RESULT

Related Links

• PubMed link

Results Point of Contact

• Title: Dr B Finegan
• Organization: University of Alb erta

bfinegan@ualberta.ca

7809701302

Study Officials

• Barry A Finegan, MB

  University of Alberta

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MB, FFARC, FRCPC

Study Record Dates

• First Submitted: October 16, 2007
• First Posted: October 18, 2007
• Study Start: November 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: February 15, 2019
• Results First Posted: February 15, 2019

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)