NCT01172990

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 30, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

September 16, 2014

Status Verified

September 1, 2014

Enrollment Period

3.3 years

First QC Date

July 26, 2010

Last Update Submit

September 15, 2014

Conditions

Acute Coronary Syndrome

Keywords

ST Depression

Outcome Measures

Primary Outcomes (1)

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

    12 months (duration of study)

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (2)

Conventional Group

EXPERIMENTAL

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

Immediate Invasive Group

ACTIVE COMPARATOR

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

Interventions

Immediate Invasive ManagementPROCEDURE

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

Immediate Invasive Group
Conventional ManagementPROCEDURE

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

Conventional Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • ≤ 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Brompton And Harefield NHS Trust

Harefield, Middlesex, UB9 6JH, United Kingdom

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Miles Dalby

    Royal Brompton and Harefield NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2010

First Posted

July 30, 2010

Study Start

October 1, 2010

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

September 16, 2014

Record last verified: 2014-09

Locations

GB(1)