Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Purpose:
Hypothesis:
We hypothesize that rIP provides myocardial protection in patients presenting for heart surgery and that this protection is defined by a distinct gene expression profile with regards to genes involved in rIP and myocardial metabolism.
Study Design:
This proposal is for a randomized blinded pilot study on the use of rIP in patients requiring heart surgery.
Study Population:
The study will include 100 male and female patients undergoing elective heart surgery with cardiopulmonary bypass (CPB).
Randomization:
Patients will be randomized 1:1 to receive either rIP or no treatment.
Blinding Procedures:
The patient will be blinded as well as those performing the experimental analysis.
Interventions:
Remote Ischemic Preconditioning
rIP will be induced immediately following induction of anesthesia. Four 5 minute cycles of lower unilateral limb ischemia and reperfusion induced tourniquet inflation to 300 mmHg will constitute the preconditioning stimulus.
Blood sample collection/analysis
Other
ECG assessment on post-operative day 1, 2, and 3.
National Institute of Health stroke scale assessment will be conducted at screening and post operatively prior to hospital discharge.
Each patient will receive a telephone follow-up call at 30 days post operatively to collect adverse events and mortality data.
Experimental Methods:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| No Cuff | No Intervention | No rIP |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Barry A Finegan, MB | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta | Edmonton | Alberta | T6G 2G3 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22222469 | Result | 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. |
| Label | URL |
|---|---|
| PubMed link | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
2 patients were withdrawn for logistical reasons
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ischemic Preconditioned Group (rIP) | 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 Blood Pressure Cuff: 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. |
| FG001 | Placebo | No rIP - cuff placed but not used - actions by RA as if cuff inflated |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ischemic Preconditioned Group (rIP) | 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 Blood Pressure Cuff: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Myocardial Protection Against Ischemic Injury | High-sensitivity cardiac troponin T release as measured by peak hscTnT values and area-under-the-curve. | Posted | Mean | Standard Deviation | pg/ml | 72 hours post operatively |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ischemic Preconditioned Group (rIP) | 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 Blood Pressure Cuff: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart Failure | Cardiac disorders |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr B Finegan | University of Alb erta | 7809701302 | 780 | bfinegan@ualberta.ca |
Not provided
Not provided
Not provided
Not provided
Not provided
| BG001 | Placebo | No rIP as described for rIP group |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
No cuff inflation |
|
|
| 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 | Posted | Count of Participants | Participants | 6-month cardiovascular outcome |
|
|
|
| 0 |
| 27 |
| 3 |
| 27 |
| 0 |
| 27 |
| EG001 | No Cuff | No rIP | 1 | 28 | 3 | 28 | 0 | 28 |
| Renal Failure | Renal and urinary disorders |
|
| New Atrial Fib | Cardiac disorders |
|
Not provided
Not provided