Peripheral Arterial Disease, Vascular Surgery
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREPreconditioning
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.
PROCEDUREControl
Blood pressure cuff inflated to 40-50 mmHg in the upper extremity
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Undergoing elective major vascular surgery at the Minneapolis VA Medical Center for abdominal aortic aneurysm, carotid disease or limb ischemia. * Age \> 18. * Provides informed consent.
Exclusion criteria
* Hypertensive crisis * Peripheral arterial disease of the upper extremities * Arteriovenous (AV) fistula * Acute Coronary Syndrome (ACS) in the last 6 months * Severe valvular heart disease * Pregnant women * Unable to provide consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Troponin I Elevation Above the Upper Reference Limit (URL) | Within 3 days of the vascular operation | Troponin I is a biomarker of myocardial necrosis that may indicate myocardial damage or injury that occurs during the perioperative period |
Countries
United States
Participant flow
Recruitment details
Recruitment period: From June 2011 to September 2015
Pre-assignment details
A total of 205 patients were randomized, of which 201 received treatment. 4 patients removed from study after randomization
Participants by arm
| Arm | Count |
|---|---|
| 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 | 101 |
| 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. | 100 |
| Total | 201 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | surgery elsewhere or cancelled | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Sham | RIPC | Total |
|---|---|---|---|
| Age, Continuous | 69 years STANDARD_DEVIATION 7 | 69 years STANDARD_DEVIATION 7 | 69 years STANDARD_DEVIATION 7 |
| Region of Enrollment United States | 101 participants | 100 participants | 201 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 101 Participants | 100 Participants | 201 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 101 | 0 / 100 |
| serious Total, serious adverse events | 8 / 101 | 5 / 100 |
Outcome results
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
Time frame: Within 3 days of the vascular operation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sham | Troponin I Elevation Above the Upper Reference Limit (URL) | 25 participants |
| RIPC | Troponin I Elevation Above the Upper Reference Limit (URL) | 22 participants |