Acute Coronary Syndrome
Conditions
Keywords
ST Depression
Brief summary
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.
Interventions
PROCEDUREImmediate Invasive Management
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
PROCEDUREConventional Management
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
Sponsors
Daiichi Sankyo Co., Ltd.
Abbott Medical Devices
Royal Brompton & Harefield NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
1. ≤ 18 years of age 2. Previous Coronary Artery Bypass Grafting surgery 3. ST elevation myocardial infarction 4. Left bundle branch block (LBBB) 5. ST depression seen in patients during paced mode only 6. Heart rate ≥ 150bpm 7. Cardiogenic shock or other catastrophic state 8. If in the opinion of the physician the patient is not suitable for revascularisation due to co-morbidity 9. Patient participating in another clinical trial such that randomisation to DANCE would result in deviation from the protocol stipulations of either trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ambulance recruitment rate per million of population (corrected for 9-5 recruitment) | 12 months (duration of study) |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of ambulance recruited patients, excluded from the trial ultimately manifesting a troponin positive ACS within 72 hours | 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 |
| Percentage of patients recruited by the ambulance services ultimately manifesting a troponin positive Acute Coronary Syndrome(ACS) within 72 hours | within 72 hours |
| Major bleeding | 30 days |
| Stroke at 30 days | at 30 days |
| Unplanned hospital stay (>72 hours) | within 72 hours |
| Additional unplanned revascularisation at 30 days. | at 30 days |
Countries
United Kingdom
Outcome results
None listed