Inflammation and Acute Coronary Syndromes

• Conditions: Acute Coronary Syndromes

• Registration Number: NCT01000701
• Lead Sponsor: University of Zurich

Brief Summary

Subproject 1: Optimize prevention after acute coronary syndromes (ACS) by improving caregiver and patient education (http://elips.hug-ge.ch/eng/index_eng2.htm)

Subproject 2: Discover novel genomic biomarkers of ACS in leukocyte subsets by means of analyzing gene expression profiles and function

Subproject 3: Evaluate novel diagnostic and prognostic biomarkers in soluble form in blood/plasma and urine

Subproject 5: Visualize the vulnerable plaque using intravascular ultrasound/optical coherence tomography (IVUS/OCT) and correlate with outcome and biomarkers

Subproject 7: Characterize the effects of inflammation on progenitor/stem cell-mediated repair after ACS by means of analyzing gene expression profiles and function

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-22
• Study First Submitted QC: 2009-10-22
• Study First Posted: 2009-10-23
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-08
• Last Update Posted: 2016-09-09
• Primary Completion: 2018-01
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

• All patients with age ≥ 18 years presenting within 5 days (preferably within 72 hours) after pain onset with the main diagnosis of ACS (acute myocardial infarction: STEMI /NSTEMI and threatened infarction: unstable angina pectoris), who enter the hospital: The patients show symptoms, which are compatible with angina pectoris (chest pain, dyspnoea) and at least one of the following characteristics:

  • persistent ST-segment elevation or depression, T inversion or dynamic ECG changes, new left bundle branch block (LBBB)
  • Evidence of positive troponin by local laboratory reference values with a rise and/or fall in serial troponin levels
  • known coronary artery disease, specified as status after myocardial infarction, CABG, or PCI or newly documented ≥50% stenosis of an epicardial coronary artery during the initial catheterization

Exclusion Criteria

• Severe physical disability,
• Dementia (inability to comprehend study), OR
• Less than 1 year of life expectancy (for non-cardiac reasons).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major adverse cardiovascular events (MACE) in overall population, defined as composite of cardiac death, myocardial infarction or ischemia-driven revascularization	30 days and 12 months follow-up

Secondary Outcome Measures

Name	Time	Method
SP2/SP3/SP5: temporal change in biomarkers (12 months).	SP2/SP3/SP5: 13 months
Correlation with plaque burden and neointimal thickness assessed by IVUS/OCT imaging in ST segment elevation myocardial infarction (STEMI) subgroup (13 months)	13 months

Trial Locations

Locations (4)

University Hospital, Lausanne; 🇨🇭 Lausanne, Switzerland

University Hospital, Bern; 🇨🇭 Bern, Switzerland

University Hospital, Geneva; 🇨🇭 Geneva, Switzerland

University Hospital, Zurich; 🇨🇭 Zurich, Switzerland