The potential role of B-Type natriuretic peptide (BNP) and high-sensitivity troponin t(hs-tnt) pre-screening by GPs to better target rapid access chest pain clinic referrals
| ISRCTN | ISRCTN67362546 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67362546 |
| Protocol serial number | GEO003 |
| Sponsor | University of Dundee |
| Funder | Chest Heart and Stroke Scotland |
- Submission date
- 29/12/2009
- Registration date
- 06/04/2010
- Last edited
- 13/02/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
At present the most accurate way of telling whether chest pain is coming from the heart or from any other cause such as muscular strain is by doing a blood test 12 hours after the chest pain starts. This test is called the Troponin T test. There is a newer blood test that may be able to provide doctors with the same information much quicker so that a decision on your care can be made faster and more accurately. There is evidence from previous studies that this may be so in patients with other heart conditions. This test is called the B-Type Natriuretic Peptide (BNP) test which is the name of a hormone that is produced by the heart muscle. The aim of this study is to assess the accuracy of this test in patients who present to hospital with chest pain.
Who can participate?
Adults aged between 20 and 93 presenting to the rapid Access Chest Pain Clinic with heart-related chest pain.
What does the study involve?
Participants provide background information and then have a blood sample taken while they are having their routine blood tests when they are admitted to hospital. Participants are followed up for 12 months in order to find out if they are admitted to hospital again for chest pain.
What are the possible benefits and risks of participating?
There are no direct benefits involved with participating. There is a small risk of discomfort or bruising from the blood test.
Where is the study run from?
Ninewells Hospital (UK)
When is the study starting and how long is it expected to run for?
February 2004 to October 2009
Who is funding the study?
Chest Heart and Stroke Scotland (UK)
Who is the main contact?
Dr Jacob George
j.george@dundee.ac.uk
Contact information
Scientific
Department of Clinical Pharmacology
Centre for Cardiovascular and Lung Biology
Mailbox 2, Level 7
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom
 ORCID ID |
0000-0001-8154-8278 |
|---|---|
| Phone | +44 (0)1382 632180 |
| j.george@dundee.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective observational longitudinal cohort study |
| Secondary study design | Cohort study |
| Participant information sheet | ISRCTN67362546_PIS_30Dec09_V1.doc |
| Scientific title | The potential role of B-Type natriuretic peptide (BNP) and high-sensitivity troponin t(hs-tnt) pre-screening by GPs to better target rapid access chest pain clinic referrals: a prospective observational longitudinal cohort study |
| Study objectives | The aim of this study is to determine how accurate a pre-screening test for BNP and high-sensitivity troponin t(hs-tnt) would be in safely identifying that a potential RACPC referral was unnecessary. |
| Ethics approval(s) | Tayside Local Research Ethics Committee, 04/08/2005, ref: 05/S1402/49 |
| Health condition(s) or problem(s) studied | Cardiac chest pain |
| Intervention | 625 patients attending Rapid Access Chest Pain Clinics in Tayside were recruited into the study over a two year period. Each patient had demographic data, a near patient BNP and high-sensitivity troponin t(hs-tnt) level (Biosite®), clinical and laboratory measurements documented. The initial diagnosis was considered positive for ischaemic heart disease (IHD) if the patient had a positive troponin T or was referred for angiography. All patients were then followed up one year after their initial RACPC attendance using hospital medical records, primary care records and telephone calls to document further RACPC attendance, hospitalisations for chest pain and survival data. |
| Intervention type | Other |
| Primary outcome measure(s) |
Negative predictive value of BNP compared to final clinical diagnosis and troponin T result is measured by a near-patient assay at 12 months. |
| Key secondary outcome measure(s) |
Clinical event rate such as further admissions for chest pain, referral for angioplasty or coronary artery bypass grafting and death are assessed continuously for 12 months. |
| Completion date | 01/10/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 625 |
| Key inclusion criteria | 1. Patients presenting to the rapid Access Chest Pain Clinic with Cardiac Chest Pain 2. Aged 20 - 93 years, both male and female |
| Key exclusion criteria | Patients with non-cardiac chest pain |
| Date of first enrolment | 01/03/2007 |
| Date of final enrolment | 01/10/2008 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
Dundee
DD1 9SY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Jacob George (j.george@dundee.ac.uk) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2012 | Yes | No | |
| Participant information sheet | version V1 | 30/12/2009 | 13/02/2017 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN67362546_PIS_30Dec09_V1.doc
- Uploaded 13/02/2017
Editorial Notes
13/02/2017: The following changes have been made to the record:
1. Publication reference added
2. The overall trial dates have been updated from 01/03/2007 - 31/08/2009 to 01/02/2004 - 01/10/2009
3. The trial participating centre, ORCID ID, IPD Sharing plan and plain English summary have been added
4. The participant information sheet has been uploaded.
