Early or late intervention in high risk non-ST elevation acute coronary syndromes
| ISRCTN | ISRCTN39230163 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39230163 |
| Protocol serial number | 13407 |
| Sponsor | Isala Clinics (Isala klinieken) (Netherlands) |
| Funder | Diagram B.V., Isala Kliniek |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | 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(s) |
Combined incidence of death, re-infarction and hospitalisation for recurrent ischemia at 30 days follow-up |
| Key secondary outcome measure(s) |
1. Enzymatic infarct size as assessed by a single cardiac Troponin T, measured at 72 to 96 hours after admission or at discharge |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 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
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 | 20/05/2013 | Yes | No | |
| Results article | results | 17/11/2016 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
13/12/2016: Publication reference added.
