Remote Ischemic Preconditioning Clinical Trial
Official title:
Protection of the Heart With Remote Ischemic Preconditioning During Heart Surgery: A Pilot Study
NCT number | NCT00546390 |
Other study ID # | Protect |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2007 |
Est. completion date | April 2010 |
Verified date | October 2018 |
Source | University of Alberta |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 57 |
Est. completion date | April 2010 |
Est. primary completion date | April 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Written informed consent - Age 18 through 80 years, inclusive - Scheduled for heart surgery with CPB Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | University of Alberta | Edmonton | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Alberta |
Canada,
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 surger — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | All-cause Death and Cardiovascular Long-term Outcome | Death and re-hospitalization due to any cause including heart and renal failure and new atrial fibrillation | 6-month cardiovascular outcome |
Status | Clinical Trial | Phase | |
---|---|---|---|
Suspended |
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