Inflammation and Acute Coronary Syndromes

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01000701

Acronym

SPUM-ACS

Enrollment

4000

Registered

2009-10-23

Start date

2009-10-31

Completion date

2019-01-31

Last updated

2016-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndromes

Keywords

Inflammation, ACS, Prevention, Education, Clinical management

Brief 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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame
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

Secondary

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

Countries

Switzerland

Contacts

Primary ContactThomas F Luscher, MD

cardiotfl@gmx.ch0041 44 255

Backup ContactChristian M Matter, MD

christian.matter@uzh.ch0041 44 635

Outcome results