Direct Angioplasty for Non ST Elevation Acute Coronary Events: DANCE Pilot Study
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Royal Brompton & Harefield NHS Foundation Trust.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Royal Brompton & Harefield NHS Foundation Trust
Collaborators:
Daiichi Sankyo Co., Ltd.
Abbott Vascular
Information provided by:
Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01172990
First received: July 26, 2010
Last updated: February 11, 2011
Last verified: February 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Acute Coronary Syndrome |
Procedure: Immediate Invasive Management Procedure: Conventional Management |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Direct Angioplasty for Non ST Elevation Acute Coronary Events: DANCE Pilot Study |
Resource links provided by NLM:
Further study details as provided by Royal Brompton & Harefield NHS Foundation Trust:
Primary Outcome Measures:
- Ambulance recruitment rate per million of population (corrected for 9-5 recruitment) [ Time Frame: 12 months (duration of study) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Percentage of patients recruited by the ambulance services ultimately manifesting a troponin positive Acute Coronary Syndrome(ACS) within 72 hours [ Time Frame: within 72 hours ] [ Designated as safety issue: No ]
- Percentage of ambulance recruited patients, excluded from the trial ultimately manifesting a troponin positive ACS within 72 hours [ Time Frame: within 72 hours ] [ Designated as safety issue: No ]
- 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 [ Time Frame: within 7 days ] [ Designated as safety issue: No ]
- Death at 30 days [ Time Frame: at 30 days ] [ Designated as safety issue: Yes ]
- Recurrent non-fatal Myocardial Infarction (MI) (after 72 hours) at 30 days [ Time Frame: at 30 days ] [ Designated as safety issue: Yes ]
- Additional unplanned revascularisation at 30 days. [ Time Frame: at 30 days ] [ Designated as safety issue: No ]
- Major bleeding [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Stroke at 30 days [ Time Frame: at 30 days ] [ Designated as safety issue: Yes ]
- Unplanned hospital stay (>72 hours) [ Time Frame: within 72 hours ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 200 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Conventional Group
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
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
|
|
Active Comparator: Immediate Invasive Group
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
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria Patients presenting to the ambulance service with symptoms (onset of symptoms ≤ 6 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 in at least two electrocardiograph leads AND
Written informed consent Main exclusion criteria
- ≤ 18 years of age
- Previous Coronary Artery By-pass Graft(CABG) 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01172990
Contacts
| Contact: Marcus Flather | 020 7351 8827 | m.flather@rbht.nhs.uk |
| Contact: Elizabeth Cruddas | 020 7351 8869 | e.cruddas@rbht.nhs.uk |
Locations
| United Kingdom | |
| Royal Brompton And Harefield NHS Trust | Recruiting |
| Harefield, Middlesex, United Kingdom, UB9 6JH | |
| Contact: Miles Dalby, MBBS MD MRCP +441895 823737 m.dalby@rbht.nhs.uk | |
| Principal Investigator: Miles Dalby, MBBS MD MRCP | |
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Daiichi Sankyo Co., Ltd.
Abbott Vascular
Investigators
| Principal Investigator: | Miles Dalby | Royal Brompton and Harefield NHS Foundation Trust |
More Information
Additional Information:
No publications provided
| Responsible Party: | Dr Miles Dalby, Royal Brompton And Harefield NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT01172990 History of Changes |
| Other Study ID Numbers: | DANCE Pilot Study |
| Study First Received: | July 26, 2010 |
| Last Updated: | February 11, 2011 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
|
ST Depression |
Additional relevant MeSH terms:
|
Acute Coronary Syndrome Myocardial Ischemia Heart Diseases Cardiovascular Diseases Angina Pectoris |
Vascular Diseases Chest Pain Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on May 21, 2013