Condition category
Circulatory System
Date applied
08/04/2010
Date assigned
09/02/2011
Last edited
11/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Irene Knox

ORCID ID

Contact details

Craigavon Area Hospital
68 Lurgan Road
Portadown
BT63 5QQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

5.2

Study information

Scientific title

RApid Diagnosis And Risk stratification of Acute Coronary Syndrome with novel biochip array: an observational cohort study

Acronym

RADAR-ACS

Study hypothesis

Measurement at 4 or 6 hours after symptom onset of a panel of early biomarkers of myocardial necrosis and plaque instability with a biochip assay array will be superior to measurement of the current gold standard diagnostic assay for myocardial infarction, Troponin T in patients presenting with acute coronary syndrome (ACS).

This biomarker array will also demonstrate greater independent predictive accuracy than troponin for recurrent cardiac events at 30 days and 1 year.

Ethics approval

Office for Research Ethics Committees Northern Ireland (ORECNI) approved on 08/05/2009 (ref: 09/NIR01/22). Protocol revision (version 5.2) and subsequent favourable opinion given on 11/11/2009.

Study design

Observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Acute coronary syndrome

Intervention

Patients will have blood sampled at admission then subsequently at time intervals 1, 2, 3, 6, 12 and 24 hours after admission. Blood will be spun and serum/plasma aliquoted then frozen at -80 degrees celsius until batch analysis. Analysis with a biochip panel consisting of Troponin I, Heart type fatty acid binding protein, Glycogenphosphorylase BB, Myoglobin, Carbonic anhydrase III and creatine kinase myocardial bands (CKMB) will be compared with 4th and 5th generation troponin T assays at each time point.

Intervention type

Device

Phase

Drug names

Primary outcome measures

1. Sensitivity and specificity of investigational biomarkers when compared to troponin T at two prespecified time points after symptom onset: 4 hours, 6 hours
2. Major adverse cardiac events (MACE) defined as in hospital reinfarction (defined as further clinical signs and/or symptoms and greater than or equal to 20% increase in Troponin value 6 - 9 hours after the event), stroke, revascularisation, further admission with ACS heart failure hospitalisation, death

Secondary outcome measures

1. Bleeding complications (assessed according to the TIMI bleeding classification)
2. In hospital revascularistion. Within this subset presenting coronary anatomy and revascularisation type will be assessed
3. Length of hospital stay

Overall trial start date

27/10/2009

Overall trial end date

04/08/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Consecutive male and female patients over 18 years of age with a clinical diagnosis of possible acute coronary syndrome.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

650

Participant exclusion criteria

1. Unable to provide informed consent
2. Terminal malignancy
3. Patient received anticogulant treatment or fibrinolysis prior to enrolment

Recruitment start date

27/10/2009

Recruitment end date

04/08/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Craigavon Area Hospital
Portadown
BT63 5QQ
United Kingdom

Sponsor information

Organisation

Southern Health and Social Care Trust (UK)

Sponsor details

Craigavon Area Hospital
68 Lurgan Road
Portadown
BT63 5QQ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.southerntrust.hscni.net/

Funders

Funder type

Industry

Funder name

Randox Laboratories (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Southern Health and Social Care Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes