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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01000701
Other study ID # SPUM-ACS
Secondary ID
Status Recruiting
Phase N/A
First received October 22, 2009
Last updated September 8, 2016
Start date October 2009
Est. completion date January 2019

Study information

Verified date September 2016
Source University of Zurich
Contact Thomas F Luscher, MD
Phone 0041 44 255
Email cardiotfl@gmx.ch
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 4000
Est. completion date January 2019
Est. primary completion date January 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
Switzerland University Hospital, Bern Bern
Switzerland University Hospital, Geneva Geneva
Switzerland University Hospital, Lausanne Lausanne
Switzerland University Hospital, Zurich Zurich

Sponsors (4)

Lead Sponsor Collaborator
University of Zurich University Hospital, Geneva, University of Bern, University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary SP2/SP3/SP5: temporal change in biomarkers (12 months). SP2/SP3/SP5: 13 months Yes
Secondary Correlation with plaque burden and neointimal thickness assessed by IVUS/OCT imaging in ST segment elevation myocardial infarction (STEMI) subgroup (13 months) 13 months Yes
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