Trial Outcomes & Findings for Remote Ischemic Preconditioning Prior to Vascular Surgery (NCT NCT01558596)

NCT ID: NCT01558596

Last Updated: 2017-03-22

Results Overview

Troponin I is a biomarker of myocardial necrosis that may indicate myocardial damage or injury that occurs during the perioperative period

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 201 participants
• Primary outcome timeframe: Within 3 days of the vascular operation
• Results posted on: 2017-03-22

Participant Flow

Recruitment period: From June 2011 to September 2015

A total of 205 patients were randomized, of which 201 received treatment. 4 patients removed from study after randomization

Participant milestones

Measure	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	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.
Overall Study STARTED	104	101
Overall Study COMPLETED	101	100
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Measure	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	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.
Overall Study Withdrawal by Subject	1	0
Overall Study surgery elsewhere or cancelled	1	1
Overall Study Protocol Violation	1	0

Baseline Characteristics

Remote Ischemic Preconditioning Prior to Vascular Surgery

Baseline characteristics by cohort

Measure	Sham n=101 Participants 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	RIPC n=100 Participants 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.	Total n=201 Participants Total of all reporting groups
Age, Continuous	69 years STANDARD_DEVIATION 7 • n=5 Participants	69 years STANDARD_DEVIATION 7 • n=7 Participants	69 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	101 Participants n=5 Participants	100 Participants n=7 Participants	201 Participants n=5 Participants
Region of Enrollment United States	101 participants n=5 Participants	100 participants n=7 Participants	201 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Sham n=101 Participants Blood pressure cuff inflated to 40-50 mmHg over brachial artery	RIPC n=100 Participants Blood pressure cuff inflated to 200 mmHg over the brachial artery while confirming absence of radial and ulnar pulse. Total duration of protocol was 30 minutes, equally divided between reperfusion and ischemia.
Troponin I Elevation Above the Upper Reference Limit (URL)	25 participants	22 participants

Adverse Events

Sham

Serious events: 8 serious events

Other events: 0 other events

Deaths: 0 deaths

RIPC

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Sham n=101 participants at risk Blood pressure cuff inflated to 40 mmHg to mask controls	RIPC n=100 participants at risk 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)
Cardiac disorders Myocardial infarction	0.99% 1/101 • Number of events 2	1.0% 1/100 • Number of events 1
Surgical and medical procedures Cellulitis	5.0% 5/101 • Number of events 5	3.0% 3/100 • Number of events 3
Cardiac disorders Stroke	0.99% 1/101 • Number of events 1	0.00% 0/100
Cardiac disorders heart failure	0.00% 0/101	1.0% 1/100 • Number of events 1
Cardiac disorders pacemaker	0.99% 1/101 • Number of events 1	0.00% 0/100

Other adverse events

Adverse event data not reported

Additional Information

Santiago Garcia, MD

Minneapolis VA Medical Center

Phone: 6124673670

Email: santiago.garcia@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place