NCT01000701

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2009

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2009

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

September 9, 2016

Status Verified

September 1, 2016

Enrollment Period

8.3 years

First QC Date

October 22, 2009

Last Update Submit

September 8, 2016

Conditions

Acute Coronary Syndromes

Keywords

InflammationACSPreventionEducationClinical management

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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)

You may qualify if:

  • 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

You may not qualify if:

  • Severe physical disability,
  • Dementia (inability to comprehend study), OR
  • Less than 1 year of life expectancy (for non-cardiac reasons).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University Hospital, Geneva

Geneva, Canton of Geneva, 1211, Switzerland

RECRUITING

University Hospital, Bern

Bern, Switzerland

RECRUITING

University Hospital, Lausanne

Lausanne, Switzerland

RECRUITING

University Hospital, Zurich

Zurich, Switzerland

RECRUITING

Related Publications (17)

  • Kraler S, Liberale L, Tirandi A, Moriero M, Wang Y, Farag M, Carbone F, Bertolotto MB, Pusterla V, Ramoni D, Ministrini S, Puspitasari YM, Bruno F, Raber L, Di Vece D, Templin C, Muller O, Mach F, Crea F, Camici GG, Lapikova-Bryhinska T, Akhmedov A, von Eckardstein A, Gorog DA, Montecucco F, Luscher TF. The junctional protein associated with coronary artery disease predicts adverse cardiovascular events in patients with acute coronary syndromes at high residual risk. Eur Heart J. 2025 Dec 23:ehaf979. doi: 10.1093/eurheartj/ehaf979. Online ahead of print.

    PMID: 41430589DERIVED

  • van der Stouwe JG, Godly K, Kraler S, Godly J, Matter CM, Wenzl FA, von Eckardstein A, Raber L, Mach F, Obeid S, Templin C, Luscher TF, Niederseer D; SPUM-ACS investigators. Body temperature, systemic inflammation and risk of adverse events in patients with acute coronary syndromes. Eur J Clin Invest. 2024 Dec;54(12):e14314. doi: 10.1111/eci.14314. Epub 2024 Sep 30.

    PMID: 39350322DERIVED

  • Davies A, Wenzl FA, Li XS, Winzap P, Obeid S, Klingenberg R, Mach F, Raber L, Muller O, Matter CM, Laaksonen R, Wang Z, Hazen SL, Luscher TF. Short and medium chain acylcarnitines as markers of outcome in diabetic and non-diabetic subjects with acute coronary syndromes. Int J Cardiol. 2023 Oct 15;389:131261. doi: 10.1016/j.ijcard.2023.131261. Epub 2023 Aug 11.

    PMID: 37574027DERIVED

  • Bruno F, Adjibodou B, Obeid S, Kraler SC, Wenzl FA, Akhtar MM, Denegri A, Roffi M, Muller O, von Eckardstein A, Raber L, Templin C, Luscher TF. Occlusion of the infarct-related coronary artery presenting as acute coronary syndrome with and without ST-elevation: impact of inflammation and outcomes in a real-world prospective cohort. Eur Heart J Qual Care Clin Outcomes. 2023 Sep 12;9(6):564-574. doi: 10.1093/ehjqcco/qcad027.

    PMID: 37197909DERIVED

  • Gilgien-Denereaz L, Jakob J, Tal K, Gencer B, Carballo D, Raber L, Klingenberg R, Matter CM, Sudano I, Luscher TF, Windecker S, Muller O, Fournier S, Rodondi N, Mach F, Auer R, Nanchen D. Long-term effects of systematic smoking cessation counselling during acute coronary syndrome, a multicentre before-after study. Swiss Med Wkly. 2022 Jul 18;152:w30209. doi: 10.4414/smw.2022.w30209. eCollection 2022 Jul 18.

    PMID: 35964324DERIVED

  • Kraler S, Wenzl FA, Georgiopoulos G, Obeid S, Liberale L, von Eckardstein A, Muller O, Mach F, Raber L, Losdat S, Schmiady MO, Stellos K, Stamatelopoulos K, Camici GG, Srdic A, Paneni F, Akhmedov A, Luscher TF. Soluble lectin-like oxidized low-density lipoprotein receptor-1 predicts premature death in acute coronary syndromes. Eur Heart J. 2022 May 14;43(19):1849-1860. doi: 10.1093/eurheartj/ehac143.

    PMID: 35567560DERIVED

  • Klingenberg R, Aghlmandi S, Raber L, Akhmedov A, Gencer B, Carballo D, Nanchen D, Bucher HC, Rodondi N, Mach F, Windecker S, Landmesser U, von Eckardstein A, Hamm CW, Luscher TF, Matter CM. Cysteine-Rich Angiogenic Inducer 61 Improves Prognostic Accuracy of GRACE (Global Registry of Acute Coronary Events) 2.0 Risk Score in Patients With Acute Coronary Syndromes. J Am Heart Assoc. 2021 Oct 19;10(20):e020488. doi: 10.1161/JAHA.120.020488. Epub 2021 Oct 8.

    PMID: 34622666DERIVED

  • Weichwald S, Candreva A, Burkholz R, Klingenberg R, Raber L, Heg D, Manka R, Gencer B, Mach F, Nanchen D, Rodondi N, Windecker S, Laaksonen R, Hazen SL, von Eckardstein A, Ruschitzka F, Luscher TF, Buhmann JM, Matter CM. Improving 1-year mortality prediction in ACS patients using machine learning. Eur Heart J Acute Cardiovasc Care. 2021 Oct 27;10(8):855-865. doi: 10.1093/ehjacc/zuab030.

    PMID: 34015112DERIVED

  • Rossi VA, Denegri A, Candreva A, Klingenberg R, Obeid S, Raber L, Gencer B, Mach F, Nanchen D, Rodondi N, Heg D, Windecker S, Buhmann J, Ruschitzka F, Luscher TF, Matter CM. Prognostic value of inflammatory biomarkers and GRACE score for cardiac death and acute kidney injury after acute coronary syndromes. Eur Heart J Acute Cardiovasc Care. 2021 May 25;10(4):445-452. doi: 10.1093/ehjacc/zuab003.

    PMID: 33624028DERIVED

  • Winzap P, Davies A, Klingenberg R, Obeid S, Roffi M, Mach F, Raber L, Windecker S, Templin C, Nietlispach F, Nanchen D, Gencer B, Muller O, Matter CM, von Eckardstein A, Luscher TF. Diabetes and baseline glucose are associated with inflammation, left ventricular function and short- and long-term outcome in acute coronary syndromes: role of the novel biomarker Cyr 61. Cardiovasc Diabetol. 2019 Oct 31;18(1):142. doi: 10.1186/s12933-019-0946-6.

    PMID: 31672144DERIVED

  • Koskinas KC, Zanchin T, Klingenberg R, Gencer B, Temperli F, Baumbach A, Roffi M, Moschovitis A, Muller O, Tuller D, Stortecky S, Mach F, Luscher TF, Matter CM, Pilgrim T, Heg D, Windecker S, Raber L. Incidence, Predictors, and Clinical Impact of Early Prasugrel Cessation in Patients With ST-Elevation Myocardial Infarction. J Am Heart Assoc. 2018 Apr 13;7(8):e008085. doi: 10.1161/JAHA.117.008085.

    PMID: 29654204DERIVED

  • Aghlmandi S, Scharer N, Heg D, Raber L, Zwahlen M, Gencer B, Nanchen D, Carballo D, Carballo S, Juni P, von Eckardstein A, Landmesser U, Rodondi N, Mach F, Windecker S, Matter CM, Luscher TF, Klingenberg R. Thrombus aspiration in acute coronary syndromes: prevalence, procedural success, change in serial troponin T levels and clinical outcomes in a contemporary Swiss cohort. Eur Heart J Acute Cardiovasc Care. 2018 Sep;7(6):522-531. doi: 10.1177/2048872617706480. Epub 2017 Apr 20.

    PMID: 28425755DERIVED

  • Klingenberg R, Aghlmandi S, Raber L, Gencer B, Nanchen D, Heg D, Carballo S, Rodondi N, Mach F, Windecker S, Juni P, von Eckardstein A, Matter CM, Luscher TF. Improved risk stratification of patients with acute coronary syndromes using a combination of hsTnT, NT-proBNP and hsCRP with the GRACE score. Eur Heart J Acute Cardiovasc Care. 2018 Mar;7(2):129-138. doi: 10.1177/2048872616684678. Epub 2016 Dec 28.

    PMID: 28029055DERIVED

  • Raber L, Klingenberg R, Heg D, Kelbaek H, Roffi M, Tuller D, Baumbach A, Zanchin T, Carballo D, Ostojic M, Stefanini GG, Rodondi N, von Birgelen C, Moschovitis A, Engstrom T, Gencer B, Auer R, Meier B, Mach F, Luscher TF, Juni P, Matter CM, Windecker S; COMFORTABLE and SPUM-ACS Trial Investigators. Safety of Prasugrel Loading Doses in Patients Pre-Loaded With Clopidogrel in the Setting of Primary Percutaneous Coronary Intervention: Results of a Nonrandomized Observational Study. JACC Cardiovasc Interv. 2015 Jul;8(8):1064-1074. doi: 10.1016/j.jcin.2015.03.023.

    PMID: 26205445DERIVED

  • Reiser H, Klingenberg R, Hof D, Cooksley-Decasper S, Fuchs N, Akhmedov A, Zoller S, Marques-Vidal P, Marti Soler H, Heg D, Landmesser U, Rodondi N, Mach F, Windecker S, Vollenweider P, Matter CM, Luscher TF, von Eckardstein A, Gawinecka J. Circulating FABP4 is a prognostic biomarker in patients with acute coronary syndrome but not in asymptomatic individuals. Arterioscler Thromb Vasc Biol. 2015 Aug;35(8):1872-9. doi: 10.1161/ATVBAHA.115.305365. Epub 2015 Jun 11.

    PMID: 26069234DERIVED

  • Klingenberg R, Heg D, Raber L, Carballo D, Nanchen D, Gencer B, Auer R, Jaguszewski M, Stahli BE, Jakob P, Templin C, Stefanini GG, Meier B, Vogt P, Roffi M, Maier W, Landmesser U, Rodondi N, Mach F, Windecker S, Juni P, Luscher TF, Matter CM. Safety profile of prasugrel and clopidogrel in patients with acute coronary syndromes in Switzerland. Heart. 2015 Jun;101(11):854-63. doi: 10.1136/heartjnl-2014-306925. Epub 2015 Mar 20.

    PMID: 25794517DERIVED

  • Auer R, Gencer B, Raber L, Klingenberg R, Carballo S, Carballo D, Nanchen D, Cornuz J, Vader JP, Vogt P, Juni P, Matter CM, Windecker S, Luscher TF, Mach F, Rodondi N. Quality of care after acute coronary syndromes in a prospective cohort with reasons for non-prescription of recommended medications. PLoS One. 2014 Mar 27;9(3):e93147. doi: 10.1371/journal.pone.0093147. eCollection 2014.

    PMID: 24676282DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Thrombus, blood cells, urine

MeSH Terms

Conditions

Acute Coronary SyndromeInflammation

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Thomas F Luscher, MD

CONTACT

0041 44 255cardiotfl@gmx.ch

Christian M Matter, MD

CONTACT

0041 44 635christian.matter@uzh.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2009

First Posted

October 23, 2009

Study Start

October 1, 2009

Primary Completion

January 1, 2018

Study Completion

January 1, 2019

Last Updated

September 9, 2016

Record last verified: 2016-09

Locations

CH(4)