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Slow recruitment
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| Name | Class |
|---|---|
| Daiichi Sankyo Co., Ltd. | INDUSTRY |
| Abbott Medical Devices | INDUSTRY |
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This is a pilot feasibility study to evaluate if patients with ST depression Acute Coronary Syndrome who are taken directly to the catheter laboratory for angiogram and angioplasty +/- stents will fare better that patients who are taken to the ward area and managed with drug therapy and stabilised for 24 hours before being taken to the catheter laboratory.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Group | Experimental | Patients allocated to the conventional management group will have medical stabilisation and will undergo angiogram +/- Percutaneous Coronary Intervention PCI between 24 to 48 hours from randomisation according to local policy and guidelines |
|
| Immediate Invasive Group | Active Comparator | Patients allocated to the immediate invasive strategy will be taken to the catheter lab immediately (< 90 minutes from randomisation) in accordance with local primary angioplasty policy. Angiogram +/- same sitting Percutaneous Coronary Intervention(PCI) will be performed according to local policy and guidelines |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate Invasive Management | Procedure | Patients allocated to the immediate invasive strategy will be taken to the catheter lab immediately (< 90 minutes from randomisation) in accordance with local primary angioplasty policy. Angiogram +/- same sitting PCI will be performed according to local policy and guidelines |
| Measure | Description | Time Frame |
|---|---|---|
| Ambulance recruitment rate per million of population (corrected for 9-5 recruitment) | 12 months (duration of study) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients recruited by the ambulance services ultimately manifesting a troponin positive Acute Coronary Syndrome(ACS) within 72 hours | within 72 hours | |
| Percentage of ambulance recruited patients, excluded from the trial ultimately manifesting a troponin positive ACS within 72 hours |
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Inclusion Criteria Patients presenting with symptoms (onset of symptoms ≤ 12 hours) of a suspected acute coronary syndrome (unstable angina or MI without persistent ST elevation) characterised as follows
Clinical history consistent with ongoing ischaemic chest pain and/or symptoms AND
>1mm ST depression AND/OR ≥2mm T wave inversion in at least two adjacent ECG leads Pathological T wave inversion in leads 1+4 suggesting 'LAD Syndrome' Or Ischaemic ST depression/T wave inversion not fulfilling the above criteria that is felt in the opinion of the attending physician to represent an acute coronary syndrome. AND
Written informed consent Main exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Miles Dalby | Royal Brompton and Harefield NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Brompton And Harefield NHS Trust | Harefield | Middlesex | UB9 6JH | United Kingdom |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Conventional Management | Procedure | Patients allocated to the conventional management group will have medical stabilisation and will undergo angiogram +/- PCI between 24 to 48 hours from randomisation according to local policy and guidelines |
|
| within 72 hours |
| The extent of myocardial damage will be evaluated using the area under the curve (AUC) for release of cardiac markers Creatinine Kinase Myocardial Band(CKMB) and troponin | within 7 days |
| Death at 30 days | at 30 days |
| Recurrent non-fatal Myocardial Infarction (MI) (after 72 hours) at 30 days | at 30 days |
| Additional unplanned revascularisation at 30 days. | at 30 days |
| Major bleeding | 30 days |
| Stroke at 30 days | at 30 days |
| Unplanned hospital stay (>72 hours) | within 72 hours |