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
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
-
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.