Direct Angioplasty for Non ST Elevation Acute Coronary Events: DANCE Pilot Study

Study Overview
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Brief Summary
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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.

Official Title
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Direct Angioplasty for Non ST Elevation Acute Coronary Events: DANCE Pilot Study

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Procedure: Immediate Invasive Management
* Procedure: Conventional Management


Participation Criteria
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Eligibility Criteria
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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 ≤ 18 years of age Previous Coronary Artery Bypass Grafting surgery ST elevation myocardial infarction Left bundle branch block (LBBB) ST depression seen in patients during paced mode only Heart rate ≥ 150bpm Cardiogenic shock or other catastrophic state If in the opinion of the physician the patient is not suitable for revascularisation due to co-morbidity Patient participating in another clinical trial such that randomisation to DANCE would result in deviation from the protocol stipulations of either trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional Group<br>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 | Procedure: Conventional Management<br>* 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<br>|
| Active Comparator: Immediate Invasive Group<br>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 | Procedure: Immediate Invasive Management<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ambulance recruitment rate per million of population (corrected for 9-5 recruitment) |  | 12 months (duration of study) | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ST Depression