Inflammation and Acute Coronary Syndromes (SPUM-ACS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by University of Zurich
Sponsor:
Collaborators:
University of Bern
University Hospital, Geneva
University of Lausanne Hospitals
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01000701
First received: October 22, 2009
Last updated: December 18, 2014
Last verified: December 2014
  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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • SP2/SP3/SP5: temporal change in biomarkers (12 months). [ Time Frame: SP2/SP3/SP5: 13 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Blood, Thrombus, blood cells, urine


Estimated Enrollment: 4000
Study Start Date: October 2009
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided by University of Zurich

Additional 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
Study First Received: October 22, 2009
Last Updated: December 18, 2014
Health Authority: Switzerland: Ethikkommission

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

Additional relevant MeSH terms:
Acute Coronary Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Heart Diseases
Myocardial Ischemia
Pain
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on March 25, 2015