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

ISRCTN	ISRCTN60873148
DOI	https://doi.org/10.1186/ISRCTN60873148
Protocol serial number	5.2
Sponsor	Southern Health and Social Care Trust (UK)
Funders	Randox Laboratories (UK), Southern Health and Social Care Trust (UK)

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

Primary study design	Observational
Study design	Observational cohort study
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title	RApid Diagnosis And Risk stratification of Acute Coronary Syndrome with novel biochip array: an observational cohort study
Study acronym	RADAR-ACS
Study objectives	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(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) studied	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 / device / biological / vaccine name(s)
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	04/08/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	650
Key inclusion criteria	Consecutive male and female patients over 18 years of age with a clinical diagnosis of possible acute coronary syndrome.
Key exclusion criteria	1. Unable to provide informed consent 2. Terminal malignancy 3. Patient received anticogulant treatment or fibrinolysis prior to enrolment
Date of first enrolment	27/10/2009
Date of final enrolment	04/08/2012

Locations

Countries of recruitment

United Kingdom
Northern Ireland

Study participating centre

Craigavon Area Hospital

Portadown
BT63 5QQ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

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