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
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