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Inflammation and Acute Coronary Syndromes (SPUM-ACS)

This study is currently recruiting participants.
Verified September 2016 by University of Zurich
Sponsor:
ClinicalTrials.gov Identifier:
NCT01000701
First Posted: October 23, 2009
Last Update Posted: September 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
University of Bern
University Hospital, Geneva
University of Lausanne Hospitals
Information provided by (Responsible Party):
University of Zurich
  Purpose

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


Condition
Acute Coronary Syndromes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Inflammation and Acute Coronary Syndromes (ACS) - Novel Strategies for Prevention and Clinical Management

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA
Blood, Thrombus, blood cells, urine

Estimated Enrollment: 4000
Study Start Date: October 2009
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01000701


Contacts
Contact: Thomas F Luscher, MD 0041 44 255 ext 2121 cardiotfl@gmx.ch
Contact: Christian M Matter, MD 0041 44 635 ext 6467 christian.matter@uzh.ch

Locations
Switzerland
University Hospital, Bern Recruiting
Bern, Switzerland
Contact: Stephan Windecker, MD       stephan.windecker@insel.ch   
Principal Investigator: Stephan Windecker, MD         
Sub-Investigator: Lorenz Raeber, MD         
Sub-Investigator: Peter Jueni, MD         
Sub-Investigator: Giulio G Stefanini         
University Hospital, Geneva Recruiting
Geneva, Switzerland, 1211
Contact: François Mach, MD       francois.mach@hcuge.ch   
Contact: Pierre-Frederic Keller, MD         
Principal Investigator: Francois Mach, MD         
Sub-Investigator: Pierre-Frederic Keller, MD         
Sub-Investigator: Sebastian Carballo, MD         
Sub-Investigator: David Carballo, MD         
Sub-Investigator: Thomas Perneger, MD, PhD         
Sub-Investigator: Marco Roffi, MD         
Sub-Investigator: Baris Gencer, MD         
University Hospital, Lausanne Recruiting
Lausanne, Switzerland
Contact: Nicolas Rodondi, MD       nicolas.rodondi@insel.ch   
Principal Investigator: Nicolas Rodondi, MD         
Sub-Investigator: Reto Auer, MD         
Sub-Investigator: David Nanchen, MD         
University Hospital, Zurich Recruiting
Zurich, Switzerland
Contact: Thomas F Luscher, MD       cardiotfl@gmx.ch   
Sub-Investigator: Christian M Matter, MD         
Sub-Investigator: Roland Klingenberg, MD         
Sub-Investigator: Ulf Landmesser, MD         
Sub-Investigator: Christian Templin, MD         
Sub-Investigator: Willibald Maier, MD         
Sub-Investigator: Lukas Altwegg, MD         
Principal Investigator: Thomas F Luscher, MD         
Sponsors and Collaborators
University of Zurich
University of Bern
University Hospital, Geneva
University of Lausanne Hospitals
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01000701     History of Changes
Other Study ID Numbers: SPUM-ACS
First Submitted: October 22, 2009
First Posted: October 23, 2009
Last Update Posted: September 9, 2016
Last Verified: September 2016

Keywords provided by University of Zurich:
Inflammation
ACS
Prevention
Education
Clinical management

Additional relevant MeSH terms:
Syndrome
Inflammation
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases