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

Not Applicable

Terminated

• Conditions: Acute Coronary Syndrome
• Interventions: Procedure: Conventional Management; Procedure: Immediate Invasive Management

• Registration Number: NCT01172990
• Lead Sponsor: Royal Brompton & Harefield NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-26
• Study First Submitted QC: 2010-07-29
• Study First Posted: 2010-07-30
• Study Start: 2010-10
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-15
• Last Update Posted: 2014-09-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Group	Conventional Management	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	Immediate 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 Percutaneous Coronary Intervention(PCI) will be performed according to local policy and guidelines

Primary Outcome Measures

Name	Time	Method
Ambulance recruitment rate per million of population (corrected for 9-5 recruitment)	12 months (duration of study)

Secondary Outcome Measures

Name	Time	Method
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
Recurrent non-fatal Myocardial Infarction (MI) (after 72 hours) at 30 days	at 30 days
Stroke at 30 days	at 30 days
Unplanned hospital stay (>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
Additional unplanned revascularisation at 30 days.	at 30 days
Death at 30 days	at 30 days
Major bleeding	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

Trial Locations

Locations (1)

Royal Brompton And Harefield NHS Trust; 🇬🇧 Harefield, Middlesex, United Kingdom