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ISRCTN
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ISRCTN60873148
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ClinicalTrials.gov identifier
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Public title
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RApid Diagnosis And Risk stratification of Acute Coronary Syndrome with novel biochip array
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Scientific title
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RApid Diagnosis And Risk stratification of Acute Coronary Syndrome with novel biochip array: an observational cohort study
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Acronym
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RADAR-ACS
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Serial number at source
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5.2
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Office for Research Ethics Committees Northern Ireland (ORECNI) approved on the 8th May 2009 (ref: 09/NIR01/22). Protocol revision (version 5.2) and subsequent favourable opinion given on the 11th November 2009.
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Study design
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Observational cohort study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Acute coronary syndrome
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Participants - inclusion criteria
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Consecutive male and female patients over 18 years of age with a clinical diagnosis of possible acute coronary syndrome.
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Participants - exclusion criteria
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1. Unable to provide informed consent
2. Terminal malignancy
3. Patient received anticogulant treatment or fibrinolysis prior to enrolment
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Anticipated start date
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27/10/2009
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Anticipated end date
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04/08/2012
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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650
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Interventions
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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.
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Primary outcome measure(s)
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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
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Secondary outcome measure(s)
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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
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Sources of funding
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1. Randox Laboratories (UK)
2. Southern Health and Social Care Trust (UK)
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Trial website
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Publications
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Contact name
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Mrs
Irene
Knox
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Address
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Craigavon Area Hospital
68 Lurgan Road
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City/town
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Portadown
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Zip/Postcode
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BT63 5QQ
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Country
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United Kingdom
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Sponsor
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Southern Health and Social Care Trust (UK)
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Address
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Craigavon Area Hospital
68 Lurgan Road
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City/town
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Portadown
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Zip/Postcode
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BT63 5QQ
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Country
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United Kingdom
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Sponsor website:
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http://www.southerntrust.hscni.net/
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Date applied
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08/04/2010
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Last edited
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09/02/2011
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Date ISRCTN assigned
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09/02/2011
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