Trial Outcomes & Findings for Remote Ischemic Preconditioning in ad Hoc Percutaneous Coronary Interventions (NCT NCT01158716)

Results Overview

ΔcTnI is defined as cardiac troponin I (cTnI) at 24 hours post-PCI minus cTnI before coronary angiography

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

94 participants

Primary outcome timeframe

24 hours post PCI

Results posted on

2014-04-09

Participant Flow

Participant milestones

Participant milestones
Measure	Remote Ischemic Preconditioning Remote Ischemic Preconditioning: Patients are subjected to a 5-minute ischemia of the non-dominant arm with the use of a blood pressure cuff (inflated at 200mm Hg)	Control
Overall Study STARTED	48	48
Overall Study COMPLETED	47	47
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Remote Ischemic Preconditioning in ad Hoc Percutaneous Coronary Interventions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Remote Ischemic Preconditioning n=47 Participants Remote Ischemic Preconditioning: Patients are subjected to a 5-minute ischemia of the non-dominant arm with the use of a blood pressure cuff (inflated at 200mm Hg)	Control n=47 Participants	Total n=94 Participants Total of all reporting groups
Age, Continuous	60.8 years STANDARD_DEVIATION 10.4 • n=99 Participants	60.2 years STANDARD_DEVIATION 10.9 • n=107 Participants	60.5 years STANDARD_DEVIATION 10.6 • n=206 Participants
Sex: Female, Male Female	5 Participants n=99 Participants	6 Participants n=107 Participants	11 Participants n=206 Participants
Sex: Female, Male Male	42 Participants n=99 Participants	41 Participants n=107 Participants	83 Participants n=206 Participants

PRIMARY outcome

Timeframe: 24 hours post PCI

ΔcTnI is defined as cardiac troponin I (cTnI) at 24 hours post-PCI minus cTnI before coronary angiography

Outcome measures

Outcome measures
Measure	Remote Ischemic Preconditioning n=47 Participants Remote Ischemic Preconditioning: Patients are subjected to a 5-minute ischemia of the non-dominant arm with the use of a blood pressure cuff (inflated at 200mm Hg)	Control n=47 Participants
Delta Cardiac Troponin I (ΔcTnI)	0.04 ng/mL Interval 0.01 to 0.14	0.19 ng/mL Interval 0.18 to 0.59

SECONDARY outcome

Timeframe: During coronary balloon occlusion

Chest pain severity was assessed with a 10 point scale (0: no pain, 10: most severe discomfort ever experienced)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During coronary balloon occlusion

ST-segment deviation as monitored during coronary balloon occlusion

Outcome measures

Outcome data not reported

Adverse Events

Remote Ischemic Preconditioning

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Theodoros Zografos

Cardiovasular RS

Phone: +306956161001

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place