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The investigators have previously shown that elective vascular surgery is a high-risk operation with an anticipated risk of either death or heart attack of 15%. This study is testing whether a protocol of remote ischemic preconditioning (RIPC) applied 24 hours prior to the operation is safe, feasible and reduces the incidence of an adverse, perioperative cardiac complication.
The proposed investigation has a single blind, randomized design and plans to enroll 180-205 patients who are scheduled to have major, elective vascular surgery for occlusive carotid disease, expanding abdominal aortic aneurysm (AAA), occlusive lower extremity disease and/or critical limb ischemia at the Minneapolis VA Health Care Center. 24 hours prior to the patient's scheduled vascular operation, RIPC therapy will be applied to one of the participant's upper arms to cause forearm ischemia. Clinically collected, pre-operative troponins, creatine kinase MBs (CK-MBs), EKGs along with troponins, CK-MBs and EKGs collected on day 1, 2, 3 and day 7 (if still hospitalized) will be utilized to evaluate the occurrence of perioperative, adverse cardiac events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham | Placebo Comparator | Blood pressure cuff inflated to 40-50 mmHg in the upper extremity |
|
| RIPC | Experimental | Blood pressure cuff inflated to 200 mmHg in the upper extremity for 5 minutes to cause forearm ischemia by external compression of the brachial artery. This will be followed by 5 minutes of cuff deflation to allow for preperfusion. The ischemia-reperfusion cycle will be repeated 3 times for a total duration of 30 minutes, equally divided between ischemia and reperfusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preconditioning | Procedure | Blood pressure cuff inflated to 200 mmHg in the upper extremity for 5 minutes to cause forearm ischemia by external compression of the brachial artery. This will be followed by 5 minutes of cuff deflation to allow for preperfusion. The ischemia-reperfusion cycle will be repeated 3 times for a total duration of 30 minutes, equally divided between ischemia and reperfusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Troponin I Elevation Above the Upper Reference Limit (URL) | Troponin I is a biomarker of myocardial necrosis that may indicate myocardial damage or injury that occurs during the perioperative period | Within 3 days of the vascular operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Santiago A Garcia, MD | Minneapolis VA Health Care System, Minneapolis, MN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minneapolis VA Health Care System, Minneapolis, MN | Minneapolis | Minnesota | 55417 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27688236 | Result | Garcia S, Rector TS, Zakharova M, Herrmann RR, Adabag S, Bertog S, Sandoval Y, Santilli S, Brilakis ES, McFalls EO. Cardiac Remote Ischemic Preconditioning Prior to Elective Vascular Surgery (CRIPES): A Prospective, Randomized, Sham-Controlled Phase II Clinical Trial. J Am Heart Assoc. 2016 Sep 29;5(10):e003916. doi: 10.1161/JAHA.116.003916. | |
| 36645250 |
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A total of 205 patients were randomized, of which 201 received treatment. 4 patients removed from study after randomization
Recruitment period: From June 2011 to September 2015
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham | Blood pressure cuff inflated to 40-50 mmHg in the upper extremity Control: Blood pressure cuff inflated to 40-50 mmHg in the upper extremity |
| FG001 | RIPC | Blood pressure cuff inflated to 200 mmHg in the upper extremity for 5 minutes to cause forearm ischemia by external compression of the brachial artery. This will be followed by 5 minutes of cuff deflation to allow for preperfusion. The ischemia-reperfusion cycle will be repeated 3 times for a total duration of 30 minutes, equally divided between ischemia and reperfusion. Preconditioning: Blood pressure cuff inflated to 200 mmHg in the upper extremity for 5 minutes to cause forearm ischemia by external compression of the brachial artery. This will be followed by 5 minutes of cuff deflation to allow for preperfusion. The ischemia-reperfusion cycle will be repeated 3 times for a total duration of 30 minutes, equally divided between ischemia and reperfusion. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sham | Blood pressure cuff inflated to 40-50 mmHg in the upper extremity Control: Blood pressure cuff inflated to 40-50 mmHg in the upper extremity |
| BG001 | RIPC | Blood pressure cuff inflated to 200 mmHg in the upper extremity for 5 minutes to cause forearm ischemia by external compression of the brachial artery. This will be followed by 5 minutes of cuff deflation to allow for preperfusion. The ischemia-reperfusion cycle will be repeated 3 times for a total duration of 30 minutes, equally divided between ischemia and reperfusion. Preconditioning: Blood pressure cuff inflated to 200 mmHg in the upper extremity for 5 minutes to cause forearm ischemia by external compression of the brachial artery. This will be followed by 5 minutes of cuff deflation to allow for preperfusion. The ischemia-reperfusion cycle will be repeated 3 times for a total duration of 30 minutes, equally divided between ischemia and reperfusion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Troponin I Elevation Above the Upper Reference Limit (URL) | Troponin I is a biomarker of myocardial necrosis that may indicate myocardial damage or injury that occurs during the perioperative period | Posted | Number | participants | Within 3 days of the vascular operation |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sham | Blood pressure cuff inflated to 40 mmHg to mask controls |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Santiago Garcia, MD | Minneapolis VA Medical Center | 6124673670 | santiago.garcia@va.gov |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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|
| Control | Procedure | Blood pressure cuff inflated to 40-50 mmHg in the upper extremity |
|
| Liang F, Liu S, Liu G, Liu H, Wang Q, Song B, Yao L. Remote ischaemic preconditioning versus no remote ischaemic preconditioning for vascular and endovascular surgical procedures. Cochrane Database Syst Rev. 2023 Jan 16;1(1):CD008472. doi: 10.1002/14651858.CD008472.pub3. |
| Protocol Violation |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 8 |
| 101 |
| 0 |
| 101 |
| EG001 | RIPC | Blood pressure cuff inflated above systolic blood pressure (200 mmHg) over brachial artery to induce forearm ischemia. Total duration of protocol 30 minutes equally divided between ischemia ( 5 minutes x 3) and reperfusion ( 5 minutes x3) | 5 | 100 | 0 | 100 |
| Cellulitis | Surgical and medical procedures | Cellulitis/surgical site infection |
|
| Stroke | Cardiac disorders |
|
| heart failure | Cardiac disorders |
|
| pacemaker | Cardiac disorders |
|
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |