Inflammation and Acute Coronary Syndromes (SPUM-ACS)

September 8, 2016 updated by: University of Zurich

Inflammation and Acute Coronary Syndromes (ACS) - Novel Strategies for Prevention and Clinical Management

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

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland
        • Recruiting
        • University Hospital, Bern
        • Principal Investigator:
          • Stephan Windecker, MD
        • Contact:
        • Sub-Investigator:
          • Lorenz Raeber, MD
        • Sub-Investigator:
          • Peter Jueni, MD
        • Sub-Investigator:
          • Giulio G Stefanini
      • Geneva, Switzerland, 1211
        • Recruiting
        • University Hospital, Geneva
        • Contact:
        • 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
      • Lausanne, Switzerland
        • Recruiting
        • University Hospital, Lausanne
        • Contact:
        • Principal Investigator:
          • Nicolas Rodondi, MD
        • Sub-Investigator:
          • Reto Auer, MD
        • Sub-Investigator:
          • David Nanchen, MD
      • Zurich, Switzerland
        • Recruiting
        • University Hospital, Zürich
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
30 days and 12 months follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
SP2/SP3/SP5: temporal change in biomarkers (12 months).
Time Frame: SP2/SP3/SP5: 13 months
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
13 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Collaborators

University Hospital, Geneva
University of Lausanne Hospitals
University of Bern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

October 22, 2009

First Submitted That Met QC Criteria

October 22, 2009

First Posted (Estimate)

October 23, 2009

Study Record Updates

Last Update Posted (Estimate)

September 9, 2016

Last Update Submitted That Met QC Criteria

September 8, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPUM-ACS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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