Condition category
Circulatory System
Date applied
22/11/2006
Date assigned
22/11/2006
Last edited
21/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.diagram-zwolle.nl

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

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

Not specified

Trial type

Treatment

Patient 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

Other

Phase

Not Specified

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

Not Specified

Gender

Not Specified

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) (The 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

1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23685295

Publication citations

  1. 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.

Additional files

Editorial Notes