Trial Outcomes & Findings for Protection of the Heart With Remote Ischemic Preconditioning During Heart Surgery: A Pilot Study (NCT NCT00546390)

NCT ID: NCT00546390

Last Updated: 2019-02-15

Results Overview

High-sensitivity cardiac troponin T release as measured by peak hscTnT values and area-under-the-curve.

Recruitment status

COMPLETED

Study phase

Target enrollment

57 participants

Primary outcome timeframe

72 hours post operatively

Results posted on

2019-02-15

Participant Flow

2 patients were withdrawn for logistical reasons

Participant milestones

Participant milestones
Measure	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.	Placebo No rIP - cuff placed but not used - actions by RA as if cuff inflated
Overall Study STARTED	27	28
Overall Study COMPLETED	27	28
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ischemic Preconditioned Group (rIP) n=27 Participants 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.	Placebo n=28 Participants No rIP as described for rIP group	Total n=55 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=27 Participants	0 Participants n=28 Participants	0 Participants n=55 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=27 Participants	15 Participants n=28 Participants	28 Participants n=55 Participants
Age, Categorical >=65 years	14 Participants n=27 Participants	13 Participants n=28 Participants	27 Participants n=55 Participants
Age, Continuous	59 Years STANDARD_DEVIATION 7 • n=27 Participants	62 Years STANDARD_DEVIATION 10 • n=28 Participants	61 Years STANDARD_DEVIATION 8 • n=55 Participants
Sex: Female, Male Female	1 Participants n=27 Participants	4 Participants n=28 Participants	5 Participants n=55 Participants
Sex: Female, Male Male	26 Participants n=27 Participants	24 Participants n=28 Participants	50 Participants n=55 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	27 participants n=27 Participants	28 participants n=28 Participants	55 participants n=55 Participants

PRIMARY outcome

Timeframe: 72 hours post operatively

High-sensitivity cardiac troponin T release as measured by peak hscTnT values and area-under-the-curve.

Outcome measures

Outcome measures
Measure	Ischemic Preconditioned Group (rIP) n=27 Participants 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.	Placebo n=28 Participants No cuff inflation
Myocardial Protection Against Ischemic Injury	298 pg/ml Standard Deviation 266	231 pg/ml Standard Deviation 133

SECONDARY outcome

Timeframe: 6-month cardiovascular outcome

Death and re-hospitalization due to any cause including heart and renal failure and new atrial fibrillation

Outcome measures

Outcome measures
Measure	Ischemic Preconditioned Group (rIP) n=27 Participants 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.	Placebo n=28 Participants No cuff inflation
All-cause Death and Cardiovascular Long-term Outcome	0 Participants	1 Participants

Adverse Events

Ischemic Preconditioned Group (rIP)

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

No Cuff

Serious events: 3 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Ischemic Preconditioned Group (rIP) n=27 participants at risk 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.	No Cuff n=28 participants at risk No rIP
Cardiac disorders Heart Failure	11.1% 3/27 • Number of events 3	3.6% 1/28
Renal and urinary disorders Renal Failure	0.00% 0/27	3.6% 1/28
Cardiac disorders New Atrial Fib	0.00% 0/27	3.6% 1/28

Other adverse events

Adverse event data not reported

Additional Information

Dr B Finegan

University of Alb erta

Phone: 7809701302

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place