Inflammation and Acute Coronary Syndromes (SPUM-ACS)
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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 |
- 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 ]
- 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 |
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)
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| 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 |
| 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 | |
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 May 16, 2013