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

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.

Study Overview

• Status: Terminated
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Procedure: Conventional Management; Procedure: Immediate Invasive Management

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Middlesex
    • Harefield, Middlesex, United Kingdom, UB9 6JH
      • Royal Brompton and Harefield NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ambulance recruitment rate per million of population (corrected for 9-5 recruitment)	12 months (duration of study)

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients recruited by the ambulance services ultimately manifesting a troponin positive Acute Coronary Syndrome(ACS) within 72 hours	within 72 hours
Percentage of ambulance recruited patients, excluded from the trial ultimately manifesting a troponin positive ACS within 72 hours	within 72 hours
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	within 7 days
Death at 30 days	at 30 days
Recurrent non-fatal Myocardial Infarction (MI) (after 72 hours) at 30 days	at 30 days
Additional unplanned revascularisation at 30 days.	at 30 days
Major bleeding	30 days
Stroke at 30 days	at 30 days
Unplanned hospital stay (>72 hours)	within 72 hours

Collaborators and Investigators

• Sponsor: Royal Brompton & Harefield NHS Foundation Trust
• Collaborators: Abbott Medical Devices; Daiichi Sankyo Co., Ltd.
• Investigators: Principal Investigator: Miles Dalby, Royal Brompton and Harefield NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: July 26, 2010
• First Submitted That Met QC Criteria: July 29, 2010
• First Posted (Estimate): July 30, 2010

Study Record Updates

• Last Update Posted (Estimate): September 16, 2014
• Last Update Submitted That Met QC Criteria: September 15, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: ST Depression
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Acute Coronary Syndrome
• Other Study ID Numbers: DANCE Pilot Study