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

Acute Coronary Syndrome Clinical Trial

— DANCE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01172990
• Other study ID #: DANCE Pilot Study
• Status: Terminated
• Phase: N/A
• First received: July 26, 2010
• Last updated: September 15, 2014
• Start date: October 2010
• Est. completion date: February 2014

Study information

• Verified date: September 2014
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 108
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Intervention

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
• 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

Locations

Country	Name	City	State
United Kingdom	Royal Brompton And Harefield NHS Trust	Harefield	Middlesex

Sponsors (3)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust	Abbott Vascular, Daiichi Sankyo Co., Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ambulance recruitment rate per million of population (corrected for 9-5 recruitment)		12 months (duration of study)	No
Secondary	Percentage of patients recruited by the ambulance services ultimately manifesting a troponin positive Acute Coronary Syndrome(ACS) within 72 hours		within 72 hours	No
Secondary	Percentage of ambulance recruited patients, excluded from the trial ultimately manifesting a troponin positive ACS within 72 hours		within 72 hours	No
Secondary	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	No
Secondary	Death at 30 days		at 30 days	Yes
Secondary	Recurrent non-fatal Myocardial Infarction (MI) (after 72 hours) at 30 days		at 30 days	Yes
Secondary	Additional unplanned revascularisation at 30 days.		at 30 days	No
Secondary	Major bleeding		30 days	Yes
Secondary	Stroke at 30 days		at 30 days	Yes
Secondary	Unplanned hospital stay (>72 hours)		within 72 hours	Yes

External Links

•   DANCE Pilot Study Web Site