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Inflammation and Acute Coronary Syndromes (SPUM-ACS)

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ClinicalTrials.gov Identifier: NCT01000701
Recruitment Status : Unknown
Verified September 2016 by University of Zurich.
Recruitment status was:  Recruiting
First Posted : October 23, 2009
Last Update Posted : September 9, 2016
Sponsor:
Collaborators:
University of Bern
University Hospital, Geneva
University of Lausanne Hospitals
Information provided by (Responsible Party):
University of Zurich

Tracking Information
First Submitted Date October 22, 2009
First Posted Date October 23, 2009
Last Update Posted Date September 9, 2016
Study Start Date October 2009
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 3, 2012)
Major adverse cardiovascular events (MACE) in overall population, defined as composite of cardiac death, myocardial infarction or ischemia-driven revascularization [ Time Frame: 30 days and 12 months follow-up ]
Original Primary Outcome Measures
 (submitted: October 22, 2009)
Major adverse cardiovascular events (MACE) in overall population, defined as composite of cardiac death, target-vessel related myocardial infarction or ischemia-driven target lesion revascularization [ Time Frame: 30 days and 12 months follow-up ]
Change History Complete list of historical versions of study NCT01000701 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 22, 2009)
  • SP2/SP3/SP5: temporal change in biomarkers (12 months). [ Time Frame: 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) [ Time Frame: 13 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Inflammation and Acute Coronary Syndromes
Official Title Inflammation and Acute Coronary Syndromes (ACS) - Novel Strategies for Prevention and Clinical Management
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood, Thrombus, blood cells, urine
Sampling Method Probability Sample
Study Population

Patients presenting with Acute Coronary Syndromes

3 control groups:

  • patients with stable coronary artery disease
  • healthy controls (blood bank)
  • peripheral artery occlusive disease (CLI/ALI)
Condition Acute Coronary Syndromes
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: December 18, 2014)
4000
Original Estimated Enrollment
 (submitted: October 22, 2009)
2400
Estimated Study Completion Date January 2019
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT01000701
Other Study ID Numbers SPUM-ACS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Zurich
Study Sponsor University of Zurich
Collaborators
  • University of Bern
  • University Hospital, Geneva
  • University of Lausanne Hospitals
Investigators Not Provided
PRS Account University of Zurich
Verification Date September 2016