Post Procedural Myocardial Infarction
Conditions
Brief summary
This study investigates the cardioprotective effect of remote ischaemic pre-/postconditioning in patients presenting with a NSTEMI/Unstable angina undergoing PCI.
Detailed description
Patients presenting with Non ST elevation acute coronary syndromes (NSTEACS) - NSTEMI and Unstable angina patients are enrolled in this study. 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.
Interventions
DEVICERemote 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.
DEVICESham protocol
An un-inflated blood pressure cuff will be placed on the arm for 20 minutes.
Sponsors
University College London Hospitals
Surrey and Sussex Healthcare NHS Trust
University College, London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients admitted with NSTEMI/ Unstable angina undergoing percutaneous intervention
Exclusion criteria
* Known renal failure * Known liver disease * Peripheral vascular disease involving upper limbs * Inability to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peri-Procedural Myocardial Injury | 24 hours post PCI | Peri-Procedural Myocardial Injury will be assessed by the number of patients with peak troponin-T\>3x 99th percentile upper reference limit |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 99 |
| 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. | 119 |
| Total | 218 |
Baseline characteristics
| Characteristic | Control Group | Total | Remote Conditioning Group |
|---|---|---|---|
| Age, Continuous | 63.7 years STANDARD_DEVIATION 11 | 62.9 years STANDARD_DEVIATION 11.1 | 62.1 years STANDARD_DEVIATION 11.3 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United Kingdom | 119 participants | 218 participants | 99 participants |
| Sex: Female, Male Female | 30 Participants | 44 Participants | 14 Participants |
| Sex: Female, Male Male | 89 Participants | 174 Participants | 85 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 99 | 0 / 119 |
| other Total, other adverse events | 0 / 99 | 0 / 119 |
| serious Total, serious adverse events | 0 / 99 | 0 / 119 |
Outcome results
Primary
Peri-Procedural Myocardial Injury
Peri-Procedural Myocardial Injury will be assessed by the number of patients with peak troponin-T\>3x 99th percentile upper reference limit
Time frame: 24 hours post PCI
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Remote Conditioning Group | Peri-Procedural Myocardial Injury | 23 Participants |
| Control Group | Peri-Procedural Myocardial Injury | 29 Participants |