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

Royal Brompton & Harefield NHS Foundation Trust

Status: Terminated

Conditions: Acute Coronary Syndrome

Treatments: Procedure: Conventional Management; Procedure: Immediate Invasive Management

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01172990

DANCE Pilot Study

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

Conventional Group

Experimental group

Description:

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

Treatment:

Procedure: Conventional Management

Immediate Invasive Group

Active Comparator group

Description:

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

Treatment:

Procedure: Immediate Invasive Management