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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2014-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Conventional Management

Intervention Type PROCEDURE

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

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

Group Type ACTIVE_COMPARATOR

Immediate Invasive Management

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No