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
Scientific
Craigavon Area Hospital
68 Lurgan Road
Portadown
BT63 5QQ
United Kingdom
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 27/10/2009 |
| Completion date | 04/08/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
- Northern Ireland
- United Kingdom
Study participating centre
Craigavon Area Hospital
Portadown
BT63 5QQ
United Kingdom
BT63 5QQ
United Kingdom
Sponsor information
Southern Health and Social Care Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Craigavon Area Hospital
68 Lurgan Road
Portadown
BT63 5QQ
Northern Ireland
United Kingdom
| Website | http://www.southerntrust.hscni.net/ |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
04/10/2017: No publications found in PubMed, verifying study status with principal investigator.
