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| Name | Class |
|---|---|
| University College London Hospitals | OTHER |
| Surrey and Sussex Healthcare NHS Trust | OTHER |
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This study investigates the cardioprotective effect of remote ischaemic pre-/postconditioning in patients presenting with a NSTEMI/Unstable angina undergoing PCI.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote Conditioning group | Active Comparator | 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. |
|
| Control Group | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Conditioning | Device | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 hours post PCI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Derek M Yellon, PhD, FACC | University College, London | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | 24 hours post PCI |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Derek Hausenloy | University College London | +6584053767 | d.hausenloy@ucl.ac.uk |
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| Sham protocol | Device | An un-inflated blood pressure cuff will be placed on the arm for 20 minutes. |
|
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | 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.
|
|
| 0 |
| 99 |
| 0 |
| 99 |
| 0 |
| 99 |
| EG001 | 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. | 0 | 119 | 0 | 119 | 0 | 119 |
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