Clinical trial NCT01172990: Direct Angioplasty for Non ST Elevation Acute Coronary Events: DANCE Pilot Study
Official title: Direct Angioplasty for Non ST Elevation Acute Coronary Events: DANCE Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: ST Depression
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Daiichi Sankyo Co., Ltd.
name: Abbott Medical Devices
First posted: 2010-07-30
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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.

Primary outcomes:
measure: Ambulance recruitment rate per million of population (corrected for 9-5 recruitment)
timeFrame: 12 months (duration of study)
Secondary outcomes:
measure: Percentage of patients recruited by the ambulance services ultimately manifesting a troponin positive Acute Coronary Syndrome(ACS) within 72 hours
timeFrame: within 72 hours
measure: Percentage of ambulance recruited patients, excluded from the trial ultimately manifesting a troponin positive ACS within 72 hours
timeFrame: within 72 hours
measure: 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
timeFrame: within 7 days
measure: Death at 30 days
timeFrame: at 30 days
measure: Recurrent non-fatal Myocardial Infarction (MI) (after 72 hours) at 30 days
timeFrame: at 30 days
measure: Additional unplanned revascularisation at 30 days.
timeFrame: at 30 days
measure: Major bleeding
timeFrame: 30 days
measure: Stroke at 30 days
timeFrame: at 30 days
measure: Unplanned hospital stay (>72 hours)
timeFrame: within 72 hours
Other outcomes:
Locations:
city: Harefield
country: United Kingdom
facility: Royal Brompton And Harefield NHS Trust
state: Middlesex
Study officials:
affiliation: Royal Brompton and Harefield NHS Foundation Trust
name: Miles Dalby
role: PRINCIPAL_INVESTIGATOR
References: