Inflammation and Acute Coronary Syndromes (SPUM-ACS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by University of Zurich.
Recruitment status was  Recruiting
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: February 3, 2012
Last verified: February 2012
  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

Resource links provided by NLM:


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: 2400
Study Start Date: October 2009
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (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 above 18 years 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 comparable with angina pectoris (chest pain, dyspnoea) and at least one of the following characteristics:

    • ST-segment elevation or depression, T inversion or dynamic ECG changes,
    • Evidence of positive Troponin,
    • Known coronary heart disease (status after myocardial infarction, AC-bypass surgery or PTCA).

Exclusion Criteria:

  • Severe physical disability,
  • Dementia, OR
  • Less than 1 year of life expectancy (for non-cardiac reasons).
  Contacts and Locations
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 cmatter@physiol.uzh.ch

Locations
Switzerland
University Hospital, Bern Recruiting
Bern, Switzerland
Sub-Investigator: Stephan Windecker, MD         
Sub-Investigator: Lorenz Raeber, MD         
Sub-Investigator: Peter Jueni, MD         
University Hospital, Geneva Recruiting
Geneva, Switzerland, 1211
Contact: François Mach, MD    +41223727200    francois.mach@hcuge.ch   
Contact: Pierre-Frederic Keller, MD    +41223727200    pierre-frederic.keller@hcuge.ch   
Sub-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         
University Hospital, Lausanne Recruiting
Lausanne, Switzerland
Sub-Investigator: Nicolas Rodondi, MD         
Sub-Investigator: Reto Auer, MD         
University Hospital, Zurich Recruiting
Zurich, Switzerland
Contact: Thomas F Luscher, MD    0041 44 255 ext 2121    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

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: February 3, 2012
Health Authority: Switzerland: Ethikkommission

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

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

ClinicalTrials.gov processed this record on April 17, 2014