Condition category
Circulatory System
Date applied
23/08/2007
Date assigned
30/05/2008
Last edited
27/03/2012
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

Prof Jennifer Adgey

ORCID ID

Contact details

Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BA
United Kingdom
+44 (0)2890 632171
jennifer.adgey@belfasttrust.hscni.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RGHT000406

Study information

Scientific title

Acronym

Study hypothesis

The aims of the study are to determine the optimal electrocardiographic lead number and positions for the accurate detection of acute Myocardial Infarction (MI).

Ethics approval

Office for Research Ethics Committees in Northern Ireland (ORECNI). Date of approval: 15/05/2007 (ref: 07/NIR01/33)

Study design

Non-randomised controlled trial.

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Not specified

Trial type

Diagnostic

Patient information sheet

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

Condition

Acute coronary syndromes

Intervention

All participants will be assessed by both Reduced Lead Body Surface Map and 12 Lead ECG. All management decisions will be made using the 12 Lead ECG only (as is current practice).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Improved diagnostic yield of Body Surface Map over the 12 lead ECG

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/08/2006

Overall trial end date

01/08/2008

Reason abandoned

Eligibility

Participant inclusion criteria

All patients presenting to the Regional Medical Cardiology Centre, Royal Victoria Hospital, with ischaemic type chest pain >20 minutes duration.

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

400

Participant exclusion criteria

Patients will be excluded if they have the following prior to the initial 12-lead ECG or reduced lead system application:
1. Pain <20 minutes
2. Receive fibrinolytic therapy
3. Nitrates or glycoprotein inhibitors

Recruitment start date

01/08/2006

Recruitment end date

01/08/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Victoria Hospital
Belfast
BT12 6BA
United Kingdom

Sponsor information

Organisation

The Royal Hospitals (UK)

Sponsor details

c/o Professor I Young
Royal Research Office
The Royal Hospitals
274 Grosvenor Road
Belfast
BT12 6BA
United Kingdom
mary.williams@belfasttrust.hscni.net

Sponsor type

Hospital/treatment centre

Website

http://www.belfasttrust.hscni.net

Funders

Funder type

Hospital/treatment centre

Funder name

The Royal Hospitals (UK)

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

1. 2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12888126

Publication citations

  1. Results

    McClelland AJ, Owens CG, Menown IB, Lown M, Adgey AA, Comparison of the 80-lead body surface map to physician and to 12-lead electrocardiogram in detection of acute myocardial infarction., Am. J. Cardiol., 2003, 92, 3, 252-257.

Additional files

Editorial Notes