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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Royal Brompton & Harefield NHS Foundation Trust
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: May 29, 2013
Last verified: May 2013
  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: January 2014
Estimated Primary Completion Date: December 2013 (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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01172990

Contacts
Contact: Jean Booth 020 7351 8827 j.booth@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: Royal Brompton & 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: May 29, 2013
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 August 01, 2014