Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Prof J Brinkhuis
ORCID ID
Contact details
Diagram B.V.
van Nahuysplein 6
Zwolle
8011 NB
Netherlands
+31 (0)38 4262994
j.brinkhuis@diagram-zwolle.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
13407
Study information
Scientific title
Early or Late Intervention in high risk non-ST elevation Acute coronary syndromes
Acronym
ELISA-3
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
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
Phase
Drug names
Primary outcome measures
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 trial start date
01/08/2006
Overall trial end date
31/12/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
540
Participant 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
Recruitment start date
01/08/2006
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Diagram B.V.
Zwolle
8011 NB
Netherlands
Sponsor information
Organisation
Isala Clinics (Isala klinieken) (Netherlands)
Sponsor details
Locatie Weezenlanden
Department of Cardiology
Groot Wezenland 20
Zwolle
8011 JW
Netherlands
+31 (0)38 4242374
hof@diagram-zwolle.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Diagram B.V., Isala Kliniek
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
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23685295
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27933192
Publication citations
-
Results
Badings EA, The SH, Dambrink JH, van Wijngaarden J, Tjeerdsma G, Rasoul S, Timmer JR, van der Wielen ML, Lok DJ, van 't Hof AW, Early or late intervention in high-risk non-ST-elevation acute coronary syndromes: results of the ELISA-3 trial., EuroIntervention, 2013, 9, 1, 54-61, doi: 10.4244/EIJV9I1A9.