Status:
TERMINATED
Direct Angioplasty for Non ST Elevation Acute Coronary Events: DANCE Pilot Study
Lead Sponsor:
Royal Brompton & Harefield NHS Foundation Trust
Collaborating Sponsors:
Daiichi Sankyo Co., Ltd.
Abbott Medical Devices
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
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 far...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT01172990
Start Date
October 1 2010
End Date
February 1 2014
Last Update
September 16 2014
Active Locations (1)
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1
Royal Brompton And Harefield NHS Trust
Harefield, Middlesex, United Kingdom, UB9 6JH