Trial Outcomes & Findings for Remote Ischaemic Postconditioning in the Clinical Setting of NSTEACS and Urgent PCI (NCT NCT03726164)
NCT ID: NCT03726164
Last Updated: 2020-12-01
Results Overview
Peri-Procedural Myocardial Injury will be assessed by the number of patients with peak troponin-T\>3x 99th percentile upper reference limit
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
626 participants
Primary outcome timeframe
24 hours post PCI
Results posted on
2020-12-01
Participant Flow
Participant milestones
| Measure |
Remote Conditioning Group
Patients will receive a standard remote ischaemia preconditioning protocol comprising a blood pressure cuff placed on arm and inflated to 200mmHg for 5 minutes and then deflated for 5 minutes, a cycle repeated three times, prior to the PCI procedure.
Remote Conditioning: A Blood pressure cuff will be placed on the arm and inflated to 200mm hg for 5 minutes, and then deflated for 5 minutes, a cycle repeated 3 times.
|
Control Group
Patients will receive a standard sham remote ischaemia preconditioning protocol with an un-inflated cuff be placed on the arm in this group of patients for 30 minutes. This is the sham intervention for this group.
Sham protocol: An un-inflated blood pressure cuff will be placed on the arm for 20 minutes.
|
|---|---|---|
|
Overall Study
STARTED
|
310
|
316
|
|
Overall Study
COMPLETED
|
99
|
119
|
|
Overall Study
NOT COMPLETED
|
211
|
197
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Remote Conditioning Group
n=99 Participants
Patients will receive a standard remote ischaemia preconditioning protocol comprising a blood pressure cuff placed on arm and inflated to 200mmHg for 5 minutes and then deflated for 5 minutes, a cycle repeated three times, prior to the PCI procedure.
Remote Conditioning: A Blood pressure cuff will be placed on the arm and inflated to 200mm hg for 5 minutes, and then deflated for 5 minutes, a cycle repeated 3 times.
|
Control Group
n=119 Participants
Patients will receive a standard sham remote ischaemia preconditioning protocol with an un-inflated cuff be placed on the arm in this group of patients for 30 minutes. This is the sham intervention for this group.
Sham protocol: An un-inflated blood pressure cuff will be placed on the arm for 20 minutes.
|
Total
n=218 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.1 years
STANDARD_DEVIATION 11.3 • n=99 Participants
|
63.7 years
STANDARD_DEVIATION 11.0 • n=119 Participants
|
62.9 years
STANDARD_DEVIATION 11.1 • n=218 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
30 Participants
n=119 Participants
|
44 Participants
n=218 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=99 Participants
|
89 Participants
n=119 Participants
|
174 Participants
n=218 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
99 participants
n=99 Participants
|
119 participants
n=119 Participants
|
218 participants
n=218 Participants
|
PRIMARY outcome
Timeframe: 24 hours post PCIPeri-Procedural Myocardial Injury will be assessed by the number of patients with peak troponin-T\>3x 99th percentile upper reference limit
Outcome measures
| Measure |
Remote Conditioning Group
n=99 Participants
Patients will receive a standard remote ischaemia preconditioning protocol comprising a blood pressure cuff placed on arm and inflated to 200mmHg for 5 minutes and then deflated for 5 minutes, a cycle repeated three times, prior to the PCI procedure.
Remote Conditioning: A Blood pressure cuff will be placed on the arm and inflated to 200mm hg for 5 minutes, and then deflated for 5 minutes, a cycle repeated 3 times.
|
Control Group
n=119 Participants
Patients will receive a standard sham remote ischaemia preconditioning protocol with an un-inflated cuff be placed on the arm in this group of patients for 30 minutes. This is the sham intervention for this group.
Sham protocol: An un-inflated blood pressure cuff will be placed on the arm for 20 minutes.
|
|---|---|---|
|
Peri-Procedural Myocardial Injury
|
23 Participants
|
29 Participants
|
Adverse Events
Remote Conditioning Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place