Deriving a reduced lead system from the 80-lead body surface map for the electrocardiographic determination of acute myocardial infarction
| ISRCTN | ISRCTN32335049 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32335049 |
| Protocol serial number | RGHT000406 |
| Sponsor | The Royal Hospitals (UK) |
| Funder | The Royal Hospitals (UK) |
- Submission date
- 23/08/2007
- Registration date
- 30/05/2008
- Last edited
- 27/03/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Jennifer Adgey
Scientific
Scientific
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BA
United Kingdom
| Phone | +44 (0)2890 632171 |
|---|---|
| jennifer.adgey@belfasttrust.hscni.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised controlled trial. |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | 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(s) | Office for Research Ethics Committees in Northern Ireland (ORECNI). Date of approval: 15/05/2007 (ref: 07/NIR01/33) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Improved diagnostic yield of Body Surface Map over the 12 lead ECG |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/08/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 400 |
| Key inclusion criteria | All patients presenting to the Regional Medical Cardiology Centre, Royal Victoria Hospital, with ischaemic type chest pain >20 minutes duration. |
| Key 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 |
| Date of first enrolment | 01/08/2006 |
| Date of final enrolment | 01/08/2008 |
Locations
Countries of recruitment
- United Kingdom
- Northern Ireland
Study participating centre
Royal Victoria Hospital
Belfast
BT12 6BA
United Kingdom
BT12 6BA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2003 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
