Inflammation and Acute Coronary Syndromes (SPUM-ACS)
8. september 2016 opdateret af: 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
Studieoversigt
Status
Ukendt
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Forventet)
4000
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Bern, Schweiz
- Rekruttering
- University Hospital, Bern
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Ledende efterforsker:
- Stephan Windecker, MD
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Kontakt:
- Stephan Windecker, MD
- E-mail: stephan.windecker@insel.ch
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Underforsker:
- Lorenz Raeber, MD
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Underforsker:
- Peter Jueni, MD
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Underforsker:
- Giulio G Stefanini
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Geneva, Schweiz, 1211
- Rekruttering
- University Hospital, Geneva
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Kontakt:
- François Mach, MD
- E-mail: francois.mach@hcuge.ch
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Kontakt:
- Pierre-Frederic Keller, MD
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Ledende efterforsker:
- Francois Mach, MD
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Underforsker:
- Pierre-Frederic Keller, MD
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Underforsker:
- Sebastian Carballo, MD
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Underforsker:
- David Carballo, MD
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Underforsker:
- Thomas Perneger, MD, PhD
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Underforsker:
- Marco Roffi, MD
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Underforsker:
- Baris Gencer, MD
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Lausanne, Schweiz
- Rekruttering
- University Hospital, Lausanne
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Kontakt:
- Nicolas Rodondi, MD
- E-mail: nicolas.rodondi@insel.ch
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Ledende efterforsker:
- Nicolas Rodondi, MD
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Underforsker:
- Reto Auer, MD
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Underforsker:
- David Nanchen, MD
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Zurich, Schweiz
- Rekruttering
- University Hospital, Zürich
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Kontakt:
- Thomas F Luscher, MD
- E-mail: cardiotfl@gmx.ch
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Underforsker:
- Christian M Matter, MD
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Underforsker:
- Roland Klingenberg, MD
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Underforsker:
- Ulf Landmesser, MD
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Underforsker:
- Christian Templin, MD
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Underforsker:
- Willibald Maier, MD
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Underforsker:
- Lukas Altwegg, MD
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Ledende efterforsker:
- Thomas F Luscher, MD
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
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)
Beskrivelse
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).
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Major adverse cardiovascular events (MACE) in overall population, defined as composite of cardiac death, myocardial infarction or ischemia-driven revascularization
Tidsramme: 30 days and 12 months follow-up
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30 days and 12 months follow-up
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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SP2/SP3/SP5: temporal change in biomarkers (12 months).
Tidsramme: SP2/SP3/SP5: 13 months
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SP2/SP3/SP5: 13 months
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Correlation with plaque burden and neointimal thickness assessed by IVUS/OCT imaging in ST segment elevation myocardial infarction (STEMI) subgroup (13 months)
Tidsramme: 13 months
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13 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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 Mar 24:ehac143. doi: 10.1093/eurheartj/ehac143. Online ahead of print.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2009
Primær færdiggørelse (Forventet)
1. januar 2018
Studieafslutning (Forventet)
1. januar 2019
Datoer for studieregistrering
Først indsendt
22. oktober 2009
Først indsendt, der opfyldte QC-kriterier
22. oktober 2009
Først opslået (Skøn)
23. oktober 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
9. september 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. september 2016
Sidst verificeret
1. september 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SPUM-ACS
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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