Trial Outcomes & Findings for Remote Ischemic Postconditioning in Humans (NCT NCT01113008)

NCT ID: NCT01113008

Last Updated: 2015-01-21

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 266 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2015-01-21

Participant Flow

Participant milestones

Measure	Control Group Control group : In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.	Remote Postcondtioning Patients assigned to remote ischemic postconditioning (randomized controlled trial) Remote ischemic postconditioning : Patients assigned to remote ischemic postconditioning will undergo three 5-minute cycles of ischemia using a blood-pressure cuff at 200 mmHg, placed on the non-dominant arm, interrupted twice for 5 minutes with the cuff deflated
Overall Study STARTED	133	133
Overall Study COMPLETED	133	133
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Remote Ischemic Postconditioning in Humans

Baseline characteristics by cohort

Measure	Remote Postcondtioning n=118 Participants Patients assigned to remote ischemic postconditioning (randomized controlled trial) Remote ischemic postconditioning: Patients assigned to remote ischemic postconditioning will undergo three 5-minute cycles of ischemia using a blood-pressure cuff at 200 mmHg, placed on the non-dominant arm, interrupted twice for 5 minutes with the cuff deflated	Control Group n=114 Participants Control group: In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.	Total n=232 Participants Total of all reporting groups
Age, Continuous	64.8 years STANDARD_DEVIATION 10.1 • n=5 Participants	64.4 years STANDARD_DEVIATION 9.3 • n=7 Participants	64.6 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	39 Participants n=7 Participants	74 Participants n=5 Participants
Sex: Female, Male Male	83 Participants n=5 Participants	75 Participants n=7 Participants	158 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Outcome measures

Measure	Control Group n=114 Participants Control group : In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.	Remote Postcondtioning n=118 Participants Patients assigned to remote ischemic postconditioning (randomized controlled trial) Remote ischemic postconditioning : Patients assigned to remote ischemic postconditioning will undergo three 5-minute cycles of ischemia using a blood-pressure cuff at 200 mmHg, placed on the non-dominant arm, interrupted twice for 5 minutes with the cuff deflated
Maximum Increase of Troponin at 24 Hours	0.478 ng/ml Interval 0.2839 to 0.6726	0.476 ng/ml Interval 0.2842 to 0.6686

SECONDARY outcome

Timeframe: 12 month

Outcome measures

Measure	Control Group n=133 Participants Control group : In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.	Remote Postcondtioning n=133 Participants Patients assigned to remote ischemic postconditioning (randomized controlled trial) Remote ischemic postconditioning : Patients assigned to remote ischemic postconditioning will undergo three 5-minute cycles of ischemia using a blood-pressure cuff at 200 mmHg, placed on the non-dominant arm, interrupted twice for 5 minutes with the cuff deflated
Readmission Due to Acute Coronary Syndrome	1 participants	4 participants

SECONDARY outcome

Timeframe: 12 month

Outcome measures

Measure	Control Group n=133 Participants Control group : In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.	Remote Postcondtioning n=133 Participants Patients assigned to remote ischemic postconditioning (randomized controlled trial) Remote ischemic postconditioning : Patients assigned to remote ischemic postconditioning will undergo three 5-minute cycles of ischemia using a blood-pressure cuff at 200 mmHg, placed on the non-dominant arm, interrupted twice for 5 minutes with the cuff deflated
Cardiovascular Mortality	0 participants	2 participants

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Remote Postcondtioning

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Control Group n=133 participants at risk Control group : In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.	Remote Postcondtioning n=133 participants at risk Patients assigned to remote ischemic postconditioning (randomized controlled trial) Remote ischemic postconditioning : Patients assigned to remote ischemic postconditioning will undergo three 5-minute cycles of ischemia using a blood-pressure cuff at 200 mmHg, placed on the non-dominant arm, interrupted twice for 5 minutes with the cuff deflated
Cardiac disorders Mortality	0.00% 0/133	1.5% 2/133 • Number of events 2

Other adverse events

Adverse event data not reported

Additional Information

Dr Manuel Jiménez Navarro

H Virgen de la Victoria

Phone: 951 032 354

Email: jimeneznavarro@secardiologia.es

Results disclosure agreements

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