Remote Ischaemic Postconditioning in the Clinical Setting of NSTEACS and Urgent PCI
NCT ID: NCT03726164
Last Updated: 2020-12-01
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
626 participants
INTERVENTIONAL
2008-06-30
2014-12-31
Brief Summary
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Detailed Description
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Eligible patients are approached, with patient information sheets and are consented for involvement into the study. Patients are randomised to intervention or control. Patients randomised to intervention will receive 3 x 5 minutes of forearm ischaemia (with the cuff inflated to 200 mmHg) separated by 5 minutes of reperfusion between each cuff inflation, prior coronary angiography.
This protocol of episodic forearm ischaemia/reperfusion has been demonstrated to confer remote ischaemic preconditioning-induced protection.
Prior to the intervention, a blood sample will be taken to measure serum troponin T and CK-MB (baseline level). Following PCI patients will be reviewed on the wards and their ongoing recovery will be assessed and reviewed prior to discharge from the study. Troponin T and CK-MB levels will be measured for the 24 hours after PCI, at various time points (6 hour, 12 hour, 24 hour) as a measure of the degree of myocardial damage, and levels compared between the different treatment groups.
Primary end point
Myocardial injury (Peri-procedural Myocardial Infarction and Injury) measured by cTnT and CK-MB release over 24 hours after primary PCI.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Interventions
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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.
Sham protocol
An un-inflated blood pressure cuff will be placed on the arm for 20 minutes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Known liver disease
* Peripheral vascular disease involving upper limbs
* Inability to consent
18 Years
90 Years
ALL
No
Sponsors
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University College London Hospitals
OTHER
Surrey and Sussex Healthcare NHS Trust
OTHER
University College, London
OTHER
Responsible Party
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Principal Investigators
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Derek M Yellon, PhD, FACC
Role: STUDY_DIRECTOR
University College, London
Other Identifiers
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05/0138
Identifier Type: -
Identifier Source: org_study_id