Condition category
Circulatory System
Date applied
29/12/2009
Date assigned
06/04/2010
Last edited
02/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jacob George

ORCID ID

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

Rapid access chest pain clinics (RACPCs) are being established throughout the NHS. However they are costly, especially since at least 50% of referrals turn out to have non-cardiac pain. A pre-screening test before RACPC referral might reduce referrals, save money and relieve unnecessary patient anxiety. The pre-screening test which might fulfil this function is B-Type natriuretic peptide (BNP) and high-sensitivity troponin t(hs-tnt). We wish to formally study 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. We will do this by measuring BNP and high-sensitivity troponin t(hs-tnt) in 500 of the patients who are currently referred to the RACPCs in Tayside. We will also see whether BNP and high-sensitivity troponin t(hs-tnt) is able to accurately predict which patients will suffer a cardiovascular event in the year after their RACPC referral. Data in other populations make this appear a very likely prospect. We will also do a full assessment to assess all the other knock on consequences if GPs were to use BNP and high-sensitivity troponin t(hs-tnt) to select their RACPC referrals.

Ethics approval

Tayside Local Research Ethics Committee approved in 10/2005 (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

Not available in web format, please use the contact details below to request a patient information sheet

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

Secondary outcome measures

12 month follow-up for hospital free survival based on initial BNP and high-sensitivity troponin t(hs-tnt) level

Overall trial start date

01/03/2007

Overall trial end date

31/08/2009

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

31/08/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Clinical Pharmacology
Dundee
DD1 9SY
United Kingdom

Sponsor information

Organisation

University of Dundee (UK)

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 (UK) (ref: Res07/A105)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes