Acute Coronary SyndromesSPUM-ACSNCT01000701
Inflammation and Acute Coronary Syndromes
An observational study of Acute Coronary Syndromes, run by University of Zurich at 4 sites in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Coronary Syndromes
- How many people
- 4,000 participants
- Where
- 4 sitesSwitzerland
- Study dates
- Oct 2009to Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- Severe physical disability,
- Dementia (inability to comprehend study), OR
- Less than 1 year of life expectancy (for non-cardiac reasons).
Trial locations and contacts
4 sites in 1 country.
Switzerland4 sites, 4 recruiting
- Recruiting
University Hospital, Bern
Bern
Stephan Windecker, MD, stephan.windecker@insel.ch
Stephan Windecker, MD
- Recruiting
University Hospital, Geneva
Geneva, Canton of Geneva, 1211
François Mach, MD, francois.mach@hcuge.ch
Pierre-Frederic Keller, MD
- Recruiting
University Hospital, Lausanne
Lausanne
Nicolas Rodondi, MD, nicolas.rodondi@insel.ch
Nicolas Rodondi, MD
- Recruiting
University Hospital, Zurich
Zurich
Thomas F Luscher, MD, cardiotfl@gmx.ch
Christian M Matter, MD
About this study
Official title: 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
Read more
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
- Conditions
- Acute Coronary Syndromes
- Keywords
- Inflammation, ACS, Prevention, Education, Clinical management
- Medical subject headings
- Acute Coronary Syndrome, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events (MACE) in overall population, defined as composite of cardiac death, myocardial infarction or ischemia-driven revascularization
Measured: 30 days and 12 months follow-up
Secondary outcomes (2)
SP2/SP3/SP5: temporal change in biomarkers (12 months).
Measured: 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)
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionJan 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromesStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern, University Hospital, Geneva, University of Lausanne Hospitals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01000701
- Sponsor's protocol ID
- SPUM-ACS
- Acronym
- SPUM-ACS
- Status last verified
- Sep 2016
- First submitted
- 22 Oct 2009
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang YJ, Matter MA, Rossi VA, Heg D, Costantino S, Paneni F, Gallino C, Stahli BE, Raber L, Windecker S, Mach F, Gencer B, Klingenberg R, Rodondi N, Nanchen D, Levesque MP, Demler OV, Ruschitzka F, Matter CM. Interleukin-8 and other neutrophil-related biomarkers are associated with 1-year mortality in patients with acute myocardial infarction. Clin Res Cardiol. 2026 Sep 22. doi: 10.1007/s00392-026-03026-x. Online ahead of print.
PubMed 42771188Wenzl FA, Schweiger V, Smolle MA, Zech D, Akhmedov A, Wang P, Lapikova-Bryhinska T, Wang Y, Liberale L, Santos K, Ilina Y, Kraler S, Bergmann A, Kaufmann P, Kahles F, von Eckardstein A, Roffi M, Raber L, Cammann VL, Ghadri JR, Di Vece D, Luscher TF, Templin C; InterTAK and SPUM-ACS investigators. Takotsubo syndrome diagnosis: the biomarker-based BioTAK score. Eur Heart J. 2026 Aug 31:ehag597. doi: 10.1093/eurheartj/ehag597. Online ahead of print.
PubMed 42670759Kraler 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. 2026 Jul 21;47(28):3693-3707. doi: 10.1093/eurheartj/ehaf979.
PubMed 41430589van 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.
PubMed 39350322Davies 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.
PubMed 37574027Bruno 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.
PubMed 37197909Gilgien-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.
PubMed 35964324Kraler 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.
PubMed 35567560Klingenberg 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.
PubMed 34622666Weichwald 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.
PubMed 34015112Rossi 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.
PubMed 33624028Winzap 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.
PubMed 31672144Koskinas 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.
PubMed 29654204Aghlmandi 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.
PubMed 28425755Klingenberg 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.
PubMed 28029055
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammation and Acute Coronary Syndromes (ACS) - Novel Strategies for Prevention and Clinical Management
- ClinicalTrials.gov ID
- NCT01000701
- Acronym / sponsor ID
- SPUM-ACS / SPUM-ACS
- Conditions
- Acute Coronary Syndromes
- Keywords
- Inflammation, ACS, Prevention, Education, Clinical management
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- University of Bern, University Hospital, Geneva, University of Lausanne Hospitals
- Study start
- Oct 2009
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 23 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (4 listed)
- 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:
Key exclusion criteria (3 listed)
- Severe physical disability,
- Dementia (inability to comprehend study), OR
- Less than 1 year of life expectancy (for non-cardiac reasons).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
SP2/SP3/SP5: temporal change in biomarkers (12 months).
Time frame: 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)
Time frame: 13 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
- Derived from this study: PubMed 42771188Wang YJ, Matter MA, Rossi VA, Heg D, Costantino S, Paneni F, Gallino C, Stahli BE, Raber L, Windecker S, Mach F, Gencer B, Klingenberg R, Rodondi N, Nanchen D, Levesque MP, Demler OV, Ruschitzka F, Matter CM. Interleukin-8 and other neutrophil-related biomarkers are associated with 1-year mortality in patients with acute myocardial infarction. Clin Res Cardiol. 2026 Sep 22. doi: 10.1007/s00392-026-03026-x. Online ahead of print.
- Derived from this study: PubMed 42670759Wenzl FA, Schweiger V, Smolle MA, Zech D, Akhmedov A, Wang P, Lapikova-Bryhinska T, Wang Y, Liberale L, Santos K, Ilina Y, Kraler S, Bergmann A, Kaufmann P, Kahles F, von Eckardstein A, Roffi M, Raber L, Cammann VL, Ghadri JR, Di Vece D, Luscher TF, Templin C; InterTAK and SPUM-ACS investigators. Takotsubo syndrome diagnosis: the biomarker-based BioTAK score. Eur Heart J. 2026 Aug 31:ehag597. doi: 10.1093/eurheartj/ehag597. Online ahead of print.
- Derived from this study: PubMed 41430589Kraler 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. 2026 Jul 21;47(28):3693-3707. doi: 10.1093/eurheartj/ehaf979.
- Derived from this study: PubMed 39350322van 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.
- Derived from this study: PubMed 37574027Davies 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.
- Derived from this study: PubMed 37197909Bruno 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.
- Derived from this study: PubMed 35964324Gilgien-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.
- Derived from this study: PubMed 35567560Kraler 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.
- Derived from this study: PubMed 34622666Klingenberg 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.
- Derived from this study: PubMed 34015112Weichwald 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.
- Derived from this study: PubMed 33624028Rossi 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.
- Derived from this study: PubMed 31672144Winzap 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndromes, run by University of Zurich at 4 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas F Luscher, MD (0041 44 255 ext. 2121, cardiotfl@gmx.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01000701, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2016.