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

This study has been terminated.
(Slow recruitment)
Sponsor:
Collaborators:
Daiichi Sankyo Co., Ltd.
Abbott Vascular
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01172990
First received: July 26, 2010
Last updated: September 15, 2014
Last verified: September 2014

July 26, 2010
September 15, 2014
October 2010
February 2014   (final data collection date for primary outcome measure)
Ambulance recruitment rate per million of population (corrected for 9-5 recruitment) [ Time Frame: 12 months (duration of study) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01172990 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Percentage of patients recruited by the ambulance services ultimately manifesting a troponin positive 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 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 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 ]
Not Provided
Not Provided
 
Direct Angioplasty for Non ST Elevation Acute Coronary Events: DANCE Pilot Study
Direct Angioplasty for Non ST Elevation Acute Coronary Events: DANCE Pilot Study

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Acute Coronary Syndrome
  • 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
  • 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
  • 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
    Intervention: Procedure: Conventional Management
  • 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
    Intervention: Procedure: Immediate Invasive Management
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
108
February 2014
February 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01172990
DANCE Pilot Study
Yes
Royal Brompton & Harefield NHS Foundation Trust
Royal Brompton & Harefield NHS Foundation Trust
  • Daiichi Sankyo Co., Ltd.
  • Abbott Vascular
Principal Investigator: Miles Dalby Royal Brompton and Harefield NHS Foundation Trust
Royal Brompton & Harefield NHS Foundation Trust
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP