Early or late intervention in high risk non-ST elevation acute coronary syndromes
| ISRCTN | ISRCTN39230163 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39230163 |
| Secondary identifying numbers | 13407 |
- Submission date
- 22/11/2006
- Registration date
- 22/11/2006
- Last edited
- 13/12/2016
- 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 J Brinkhuis
Scientific
Scientific
Diagram B.V.
van Nahuysplein 6
Zwolle
8011 NB
Netherlands
| Phone | +31 (0)38 4262994 |
|---|---|
| j.brinkhuis@diagram-zwolle.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Early or Late Intervention in high risk non-ST elevation Acute coronary syndromes |
| Study acronym | ELISA-3 |
| Study objectives | Primary hypothesis: An immediate invasive approach (immediate angiography and revascularisation when appropriate) results in a reduction of the combined incidence of death, re-infarction or recurrent ischemia at 30 days follow-up. Secondary hypotheses: 1. An immediate invasive approach (immediate angiography and revascularisation when appropriate) results in a reduction of enzymatic infarct size as assessed by a single troponin T measurement at 72 to 96 hours after admission or at discharge. 2. An immediate invasive approach (immediate angiography and revascularisation when appropriate) results in a higher percentage of patients without a rise in Creatinine Kinase myocardial bands (CKmb) during hospital admission. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Non ST-Elevation Acute Coronary Syndrome (NSTE-ACS) |
| Intervention | Immediate angiography and revascularisation reduces compared to delayed angiography not earlier than 48 hours after admission. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Combined incidence of death, re-infarction and hospitalisation for recurrent ischemia at 30 days follow-up |
| Secondary outcome measures | 1. Enzymatic infarct size as assessed by a single cardiac Troponin T, measured at 72 to 96 hours after admission or at discharge 2. The percentage of patients without a rise in CKmb during admission |
| Overall study start date | 01/08/2006 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 540 |
| Key inclusion criteria | Ischemic Chest Pain or Dyspnoe at rest with last attack less than 24 hours with at least two out of three of the following characteristics: 1. Evidence of extensive myocardial ischemia on ElectroCardioGram (ECG): (new) cumulative ST depression more than 5 mm or temporary ST segment elevation in two contiguous leads less than 30 minutes 2. Evidence of myocardial damage: positive troponin (more than 0.05 ng/ml) or myoglobin (more than 150 microg/l) on admission or three hours later or positive CKmb fraction on admission (more than 6% of total CK) 3. Age above 65 years |
| Key exclusion criteria | 1. Persistent ST segment elevation 2. Absolute contra-indication for diagnostic angiography 3. Active bleeding 4. Cardiogenic shock 5. Acute posterior infarction 6. Life expectancy less than one year |
| Date of first enrolment | 01/08/2006 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Diagram B.V.
Zwolle
8011 NB
Netherlands
8011 NB
Netherlands
Sponsor information
Isala Clinics (Isala klinieken) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Locatie Weezenlanden
Department of Cardiology
Groot Wezenland 20
Zwolle
8011 JW
Netherlands
| Phone | +31 (0)38 4242374 |
|---|---|
| hof@diagram-zwolle.nl | |
"ROR" |
https://ror.org/046a2wj10 |
Funders
Funder type
Industry
Diagram B.V., Isala Kliniek
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 20/05/2013 | Yes | No | |
| Results article | results | 17/11/2016 | Yes | No |
Editorial Notes
13/12/2016: Publication reference added.
