Inflammation and Acute Coronary Syndromes

Acute Coronary Syndromes Clinical Trial

— SPUM-ACS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01000701
• Other study ID #: SPUM-ACS
• Status: Recruiting
• Phase: N/A
• First received: October 22, 2009
• Last updated: September 8, 2016
• Start date: October 2009
• Est. completion date: January 2019

Study information

• Verified date: September 2016
• Source: University of Zurich
• Contact: Thomas F Luscher, MD
• Phone: 0041 44 255
• Email: cardiotfl[@]gmx.ch
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: January 2019
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes
• Inflammation
• Syndrome

Locations

Country	Name	City	State
Switzerland	University Hospital, Bern	Bern
Switzerland	University Hospital, Geneva	Geneva
Switzerland	University Hospital, Lausanne	Lausanne
Switzerland	University Hospital, Zurich	Zurich

Sponsors (4)

Lead Sponsor	Collaborator
University of Zurich	University Hospital, Geneva, University of Bern, University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiovascular events (MACE) in overall population, defined as composite of cardiac death, myocardial infarction or ischemia-driven revascularization		30 days and 12 months follow-up	Yes
Secondary	SP2/SP3/SP5: temporal change in biomarkers (12 months).		SP2/SP3/SP5: 13 months	Yes
Secondary	Correlation with plaque burden and neointimal thickness assessed by IVUS/OCT imaging in ST segment elevation myocardial infarction (STEMI) subgroup (13 months)		13 months	Yes

External Links

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