RApid Diagnosis And Risk stratification of Acute Coronary Syndrome with novel biochip array

ISRCTN ISRCTN60873148
DOI https://doi.org/10.1186/ISRCTN60873148
Secondary identifying numbers 5.2
Submission date
08/04/2010
Registration date
09/02/2011
Last edited
04/10/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Irene Knox
Scientific

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

Study information

Study designObservational cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleRApid Diagnosis And Risk stratification of Acute Coronary Syndrome with novel biochip array: an observational cohort study
Study acronymRADAR-ACS
Study objectivesMeasurement 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(s)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.
Health condition(s) or problem(s) studiedAcute coronary syndrome
InterventionPatients 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 typeDevice
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure1. 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 measures1. 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 study start date27/10/2009
Completion date04/08/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants650
Key inclusion criteriaConsecutive male and female patients over 18 years of age with a clinical diagnosis of possible acute coronary syndrome.
Key exclusion criteria1. Unable to provide informed consent
2. Terminal malignancy
3. Patient received anticogulant treatment or fibrinolysis prior to enrolment
Date of first enrolment27/10/2009
Date of final enrolment04/08/2012

Locations

Countries of recruitment

  • Northern Ireland
  • United Kingdom

Study participating centre

Craigavon Area Hospital
Portadown
BT63 5QQ
United Kingdom

Sponsor information

Southern Health and Social Care Trust (UK)
Hospital/treatment centre

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

Website http://www.southerntrust.hscni.net/
ROR logo "ROR" https://ror.org/02fjtnt35

Funders

Funder type

Industry

Randox Laboratories (UK)

No information available

Southern Health and Social Care Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

04/10/2017: No publications found in PubMed, verifying study status with principal investigator.