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

Primary Purpose

Acute Coronary Syndrome

Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Immediate Invasive Management
Conventional Management
Sponsored by
Royal Brompton & Harefield NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acute Coronary Syndrome focused on measuring ST Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Royal Brompton And Harefield NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Conventional Group

Immediate Invasive Group

Arm 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

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

Outcomes

Primary Outcome Measures

Ambulance recruitment rate per million of population (corrected for 9-5 recruitment)

Secondary Outcome Measures

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

Full Information

First Posted
July 26, 2010
Last Updated
September 15, 2014
Sponsor
Royal Brompton & Harefield NHS Foundation Trust
Collaborators
Daiichi Sankyo Co., Ltd., Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT01172990
Brief Title
Direct Angioplasty for Non ST Elevation Acute Coronary Events: DANCE Pilot Study
Acronym
DANCE
Official Title
Direct Angioplasty for Non ST Elevation Acute Coronary Events: DANCE Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment
Study Start Date
October 2010 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Brompton & Harefield NHS Foundation Trust
Collaborators
Daiichi Sankyo Co., Ltd., Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
ST Depression

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Group
Arm Type
Experimental
Arm 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
Arm Title
Immediate Invasive Group
Arm Type
Active Comparator
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Immediate Invasive Management
Intervention 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 PCI will be performed according to local policy and guidelines
Intervention Type
Procedure
Intervention Name(s)
Conventional Management
Intervention Description
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
Primary Outcome Measure Information:
Title
Ambulance recruitment rate per million of population (corrected for 9-5 recruitment)
Time Frame
12 months (duration of study)
Secondary Outcome Measure Information:
Title
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
Title
Percentage of ambulance recruited patients, excluded from the trial ultimately manifesting a troponin positive ACS within 72 hours
Time Frame
within 72 hours
Title
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
Title
Death at 30 days
Time Frame
at 30 days
Title
Recurrent non-fatal Myocardial Infarction (MI) (after 72 hours) at 30 days
Time Frame
at 30 days
Title
Additional unplanned revascularisation at 30 days.
Time Frame
at 30 days
Title
Major bleeding
Time Frame
30 days
Title
Stroke at 30 days
Time Frame
at 30 days
Title
Unplanned hospital stay (>72 hours)
Time Frame
within 72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 ≤ 18 years of age Previous Coronary Artery Bypass Grafting surgery ST elevation myocardial infarction Left bundle branch block (LBBB) ST depression seen in patients during paced mode only Heart rate ≥ 150bpm Cardiogenic shock or other catastrophic state If in the opinion of the physician the patient is not suitable for revascularisation due to co-morbidity Patient participating in another clinical trial such that randomisation to DANCE would result in deviation from the protocol stipulations of either trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miles Dalby
Organizational Affiliation
Royal Brompton and Harefield NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Brompton And Harefield NHS Trust
City
Harefield
State/Province
Middlesex
ZIP/Postal Code
UB9 6JH
Country
United Kingdom

12. IPD Sharing Statement

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

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