Condition category
Circulatory System
Date applied
29/12/2009
Date assigned
06/04/2010
Last edited
13/02/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jacob George

ORCID ID

http://orcid.org/0000-0001-8154-8278

Contact details

Department of Clinical Pharmacology
Centre for Cardiovascular and Lung Biology
Mailbox 2
Level 7
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom
+44 (0)1382 632180
j.george@dundee.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

GEO003

Study information

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

Acronym

Study hypothesis

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

Tayside Local Research Ethics Committee, 04/08/2005, ref: 05/S1402/49

Study design

Prospective observational longitudinal cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

GP practices

Trial type

Diagnostic

Patient information sheet

See additional files

Condition

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 (BiositeĀ®), 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

Phase

Not Applicable

Drug names

Primary outcome measures

Negative predictive value of BNP compared to final clinical diagnosis and troponin T result is measured by a near-patient assay at 12 months.

Secondary outcome measures

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.

Overall trial start date

01/02/2004

Overall trial end date

01/10/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

625

Participant exclusion criteria

Patients with non-cardiac chest pain

Recruitment start date

01/03/2007

Recruitment end date

01/10/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Ninewells Hospital
Department of Clinical Pharmacology
Dundee
DD1 9SY
United Kingdom

Sponsor information

Organisation

University of Dundee

Sponsor details

Nethergate
Dundee
DD1 4HN
United Kingdom

Sponsor type

University/education

Website

http://www.dundee.ac.uk/

Funders

Funder type

Charity

Funder name

Chest Heart and Stroke Scotland

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal.

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)

Intention to publish date

31/12/2012

Participant level data

Available on request

Results - basic reporting

Publication summary

2012 results in https://www.ncbi.nlm.nih.gov/pubmed/21954110

Publication citations

Additional files

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.