Acute Coronary SyndromeBACCNCT02355457
Biomarkers in Acute Cardiac Care
An observational study of Acute Coronary Syndrome and Myocardial Infarction, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
The primary aim of the study is to investigate new cardiac biomarkers and algorithms to diagnose acute coronary syndrome in patients with suspected acute myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Myocardial Infarction, Chest Pain
- How many people
- 5,000 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2013to Dec 2027
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: All patients presenting with suspected myocardial infarction in the emergency department or the chest pain unit of the University Hospital Hamburg-Eppendorf.
Who may be able to join
- Symptoms suggestive of acute myocardial infarction
- Ability to provide written informed consent in accordance with Good epidemiological Practice and local legislation
- Individuals at least 18 years old
Who cannot join
- Insufficient knowledge of the German language (able to understand and write the German language)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Cardiology, University Heart Center Hamburg
Hamburg, 20246
Johannes Neumann, MD, 0049407410 ext. 56800, j.neumann@uke.de
About this study
The primary aim of the study is to investigate new cardiac biomarkers and algorithms to diagnose acute coronary syndrome in patients with suspected acute myocardial infarction.
Read the detailed description
The primary aim of the study is to detect and evaluate new cardiac biomarkers, evaluate and improve acute coronary syndrome (ACS) risk scores, which takes into account clinical, gender specific, psycho-social and lifestyle-risk factors, protein patterns and genetic variability in addition to the classical risk factors with respect to the primary endpoint of acute myocardial infarction.
Secondary study aims are :
- To provide estimates for the incidence of ACS in patients presenting with recent onset chest pain;
- To provide accurate, quantifiable measures of precursors of ACS;
- DNA, RNA, cells, and serum/plasma for comprehensive genetic, gene expression and proteomic studies
- To explore the impact of ACS candidate genes on cardiovascular risk stratification by using genome-wide analyses and a biological systems approach;
- To explore proteins relevant for ACS;
- To allow the identification of new therapeutic targets;
- To evaluate the impact of socio-economic factors on ACS and CAD risk.
Patients will be followed up during the hospital stay. Afterwards a telephone follow-up will take place after 30 days, 6, 24 and 48 months.
- Conditions
- Acute Coronary Syndrome, Myocardial Infarction, Chest Pain
- Keywords
- troponin, myocardial infarction, acs, AMI, biomarker, BACC, high-sensitivity
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Infarction, Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Suspected acute myocardial infarction | Patients with recent onset symptoms suggesting acute myocardial infarction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute myocardial infarction as index event
The primary endpoint of the study is acute myocardial infarction
Measured: Months
Secondary outcomes (1)
AMI, Mortality, heart failure and quality of life
The secondary endpoint of the study is mortality, heart failure, quality of life.
Measured: Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
- Study startJul 2013
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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
- 5,000 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johannes Neumann, MD, Principal investigator, UHZNils Sörensen, MD, Principal investigator, UHZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355457
- Sponsor's protocol ID
- PV4306
- Acronym
- BACC
- Status last verified
- May 2024
- First submitted
- 30 Jan 2015
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Neumann JT, Sorensen NA, Schwemer T, Ojeda F, Bourry R, Sciacca V, Schaefer S, Waldeyer C, Sinning C, Renne T, Than M, Parsonage W, Wildi K, Makarova N, Schnabel RB, Landmesser U, Mueller C, Cullen L, Greenslade J, Zeller T, Blankenberg S, Karakas M, Westermann D. Diagnosis of Myocardial Infarction Using a High-Sensitivity Troponin I 1-Hour Algorithm. JAMA Cardiol. 2016 Jul 1;1(4):397-404. doi: 10.1001/jamacardio.2016.0695.
PubMed 27438315Neumann JT, Sorensen NA, Ojeda F, Schwemer T, Lehmacher J, Gonner S, Jarsetz N, Keller T, Schaefer S, Renne T, Landmesser U, Clemmensen P, Makarova N, Schnabel RB, Zeller T, Karakas M, Pickering JW, Than M, Parsonage W, Greenslade J, Cullen L, Westermann D, Blankenberg S. Immediate Rule-Out of Acute Myocardial Infarction Using Electrocardiogram and Baseline High-Sensitivity Troponin I. Clin Chem. 2017 Jan;63(1):394-402. doi: 10.1373/clinchem.2016.262659. Epub 2016 Nov 30.
PubMed 27903616Volschow B, Strauss B, Sorensen NA, Thiessen N, Lehmacher J, Toprak B, Abdennadher B, Dehkordi F, Haller PM, Scharlemann L, Schock A, Petersmann A, Gauss F, Twerenbold R, Neumann JT. Diagnostic validation of a novel high-sensitivity cardiac troponin T assay. Eur Heart J Acute Cardiovasc Care. 2026 Jul 8;15(7):535-544. doi: 10.1093/ehjacc/zuag044.
PubMed 42008514Glaeser J, Lopez-Ayala P, Kellner C, Boeddinghaus J, Nestelberger T, Koechlin L, Sorensen NA, Haller PM, Bima P, Crisanti L, Spagnuolo CC, Strebel I, Hure G, Sieber S, Rubini Gimenez M, Wildi K, Wussler D, Miro O, Martin-Sanchez FJ, Keller DI, Christ M, Twerenbold R, Mahfoud F, Neumann J, Mueller C; APACE and BACC Investigators. Comparison of the European Society of Cardiology 0/1-Hour and High-Sensitivity Troponin in the Evaluation of Patients With Suspected Acute Coronary Syndrome 0/2-or-0/3-Hour Algorithms for Rapid Myocardial Infarction Diagnosis: A Prospective Multicenter Study. J Am Coll Cardiol. 2026 May 5;87(17):2261-2278. doi: 10.1016/j.jacc.2025.12.056. Epub 2026 Feb 18.
PubMed 41706062Haller PM, Schock A, Kellner C, Lehmacher J, Toprak B, Hartikainen TS, Kiss KM, Alhaou G, Peifer K, Twerenbold R, Zeller T, Westermann D, Neumann JT, Sorensen NA. Bedside echocardiography in patients with suspected acute myocardial infarction without ST elevation. Clin Res Cardiol. 2025 Aug 19. doi: 10.1007/s00392-025-02724-2. Online ahead of print.
PubMed 40828180Thiebetaen N, Pickering JW, Kellner C, Haller PM, Lehmacher J, Toprak B, Twerenbold R, Sorensen NA, Pemberton C, Troughton R, Richards AM, Sharif S, Worster A, Than M, Kavsak PA, Neumann JT. A Common Algorithm for Cardiac Troponin to Rule Out and Rule in Acute Myocardial Infarction. Can J Cardiol. 2025 Jul;41(7):1351-1360. doi: 10.1016/j.cjca.2025.02.029. Epub 2025 Feb 26.
PubMed 40021054Haller PM, Kellner C, Sorensen NA, Lehmacher J, Toprak B, Schock A, Hartikainen TS, Twerenbold R, Zeller T, Westermann D, Neumann JT. Long-term outcome of patients presenting with myocardial injury or myocardial infarction. Clin Res Cardiol. 2025 Jun;114(6):700-708. doi: 10.1007/s00392-023-02334-w. Epub 2023 Nov 20.
PubMed 37982865Haller PM, Sorensen NA, Hartikainen TS, Gossling A, Lehmacher J, Toprak B, Twerenbold R, Richter J, Banko T, Korschid S, Schmidt J, Keller T, Zeller T, Blankenberg S, Westermann D, Neumann JT. Rising and Falling High-Sensitivity Cardiac Troponin in Diagnostic Algorithms for Patients With Suspected Myocardial Infarction. J Am Heart Assoc. 2023 May 16;12(10):e027166. doi: 10.1161/JAHA.122.027166. Epub 2023 May 9.
PubMed 37158171Neumann JT, Twerenbold R, Ojeda F, Aldous SJ, Allen BR, Apple FS, Babel H, Christenson RH, Cullen L, Di Carluccio E, Doudesis D, Ekelund U, Giannitsis E, Greenslade J, Inoue K, Jernberg T, Kavsak P, Keller T, Lee KK, Lindahl B, Lorenz T, Mahler SA, Mills NL, Mokhtari A, Parsonage W, Pickering JW, Pemberton CJ, Reich C, Richards AM, Sandoval Y, Than MP, Toprak B, Troughton RW, Worster A, Zeller T, Ziegler A, Blankenberg S; ARTEMIS study group. Personalized diagnosis in suspected myocardial infarction. Clin Res Cardiol. 2023 Sep;112(9):1288-1301. doi: 10.1007/s00392-023-02206-3. Epub 2023 May 2.
PubMed 37131096von Haehling S, Muller-Hennessen M, Garfias-Veitl T, Gossling A, Neumann JT, Sorensen NA, Haller PM, Hartikainen T, Vollert JO, Mockel M, Blankenberg S, Westermann D, Giannitsis E. Role of Copeptin and hs-cTnT to Discriminate AHF from Uncomplicated NSTE-ACS with Baseline Elevated hs-cTnT-A Derivation and External Validation Study. Cells. 2023 Mar 31;12(7):1062. doi: 10.3390/cells12071062.
PubMed 37048135Lehmacher J, Neumann JT, Sorensen NA, Gossling A, Schmidt SE, Zeller T, Blankenberg S, Westermann D, Clemmensen PM. Diagnostic performance of a device for acoustic heart sound analysis in patients with suspected myocardial infarction. Open Heart. 2023 Mar;10(1):e002090. doi: 10.1136/openhrt-2022-002090.
PubMed 36858602Hartikainen TS, Gossling A, Sorensen NA, Lehmacher J, Neumann JT, Blankenberg S, Westermann D. Prognostic Implications of a Second Peak of High-Sensitivity Troponin T After Myocardial Infarction. Front Cardiovasc Med. 2022 Jan 31;8:780198. doi: 10.3389/fcvm.2021.780198. eCollection 2021.
PubMed 35174220Neumann JT, Weimann J, Sorensen NA, Hartikainen TS, Haller PM, Lehmacher J, Brocks C, Tenhaeff S, Karakas M, Renne T, Blankenberg S, Zeller T, Westermann D. A Biomarker Model to Distinguish Types of Myocardial Infarction and Injury. J Am Coll Cardiol. 2021 Aug 24;78(8):781-790. doi: 10.1016/j.jacc.2021.06.027.
PubMed 34412811Haller PM, Neumann JT, Sorensen NA, Hartikainen TS, Gossling A, Lehmacher J, Keller T, Zeller T, Blankenberg S, Westermann D. The association of anaemia and high-sensitivity cardiac troponin and its effect on diagnosing myocardial infarction. Eur Heart J Acute Cardiovasc Care. 2021 Dec 18;10(10):1187-1196. doi: 10.1093/ehjacc/zuab066.
PubMed 34350455Sorensen NA, Gossling A, Neumann JT, Hartikainen TS, Haller PM, Scharlemann L, Lehmacher J, Ziegler A, Blankenberg S, Zeller T, Nordholt G, Renne T, Westermann D. Diagnostic Validation of a High-Sensitivity Cardiac Troponin I Assay. Clin Chem. 2021 Sep 1;67(9):1230-1239. doi: 10.1093/clinchem/hvab070.
PubMed 34254126
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers in Acute Cardiac Care
- ClinicalTrials.gov ID
- NCT02355457
- Acronym / sponsor ID
- BACC / PV4306
- Conditions
- Acute Coronary Syndrome, Myocardial Infarction, Chest Pain
- Keywords
- troponin, myocardial infarction, acs, AMI, biomarker, BACC, high-sensitivity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 4 Feb 2015 (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.
The primary aim of the study is to investigate new cardiac biomarkers and algorithms to diagnose acute coronary syndrome in patients with suspected acute myocardial infarction.
Detailed description
The primary aim of the study is to detect and evaluate new cardiac biomarkers, evaluate and improve acute coronary syndrome (ACS) risk scores, which takes into account clinical, gender specific, psycho-social and lifestyle-risk factors, protein patterns and genetic variability in addition to the classical risk factors with respect to the primary endpoint of acute myocardial infarction.
Secondary study aims are :
- To provide estimates for the incidence of ACS in patients presenting with recent onset chest pain;
- To provide accurate, quantifiable measures of precursors of ACS;
- DNA, RNA, cells, and serum/plasma for comprehensive genetic, gene expression and proteomic studies
- To explore the impact of ACS candidate genes on cardiovascular risk stratification by using genome-wide analyses and a biological systems approach;
- To explore proteins relevant for ACS;
- To allow the identification of new therapeutic targets;
- To evaluate the impact of socio-economic factors on ACS and CAD risk.
Patients will be followed up during the hospital stay. Afterwards a telephone follow-up will take place after 30 days, 6, 24 and 48 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected acute myocardial infarction | – | –Patients with recent onset symptoms suggesting acute myocardial infarction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients presenting with suspected myocardial infarction in the emergency department or the chest pain unit of the University Hospital Hamburg-Eppendorf.
Key inclusion criteria (3 listed)
- Symptoms suggestive of acute myocardial infarction
- Ability to provide written informed consent in accordance with Good epidemiological Practice and local legislation
- Individuals at least 18 years old
Key exclusion criteria (1 listed)
- Insufficient knowledge of the German language (able to understand and write the German language)
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
Acute myocardial infarction as index event
Time frame: Months
The primary endpoint of the study is acute myocardial infarction
1 secondary outcome
AMI, Mortality, heart failure and quality of life
Time frame: Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Results publication: PubMed 27438315Neumann JT, Sorensen NA, Schwemer T, Ojeda F, Bourry R, Sciacca V, Schaefer S, Waldeyer C, Sinning C, Renne T, Than M, Parsonage W, Wildi K, Makarova N, Schnabel RB, Landmesser U, Mueller C, Cullen L, Greenslade J, Zeller T, Blankenberg S, Karakas M, Westermann D. Diagnosis of Myocardial Infarction Using a High-Sensitivity Troponin I 1-Hour Algorithm. JAMA Cardiol. 2016 Jul 1;1(4):397-404. doi: 10.1001/jamacardio.2016.0695.
- Results publication: PubMed 27903616Neumann JT, Sorensen NA, Ojeda F, Schwemer T, Lehmacher J, Gonner S, Jarsetz N, Keller T, Schaefer S, Renne T, Landmesser U, Clemmensen P, Makarova N, Schnabel RB, Zeller T, Karakas M, Pickering JW, Than M, Parsonage W, Greenslade J, Cullen L, Westermann D, Blankenberg S. Immediate Rule-Out of Acute Myocardial Infarction Using Electrocardiogram and Baseline High-Sensitivity Troponin I. Clin Chem. 2017 Jan;63(1):394-402. doi: 10.1373/clinchem.2016.262659. Epub 2016 Nov 30.
- Derived from this study: PubMed 42008514Volschow B, Strauss B, Sorensen NA, Thiessen N, Lehmacher J, Toprak B, Abdennadher B, Dehkordi F, Haller PM, Scharlemann L, Schock A, Petersmann A, Gauss F, Twerenbold R, Neumann JT. Diagnostic validation of a novel high-sensitivity cardiac troponin T assay. Eur Heart J Acute Cardiovasc Care. 2026 Jul 8;15(7):535-544. doi: 10.1093/ehjacc/zuag044.
- Derived from this study: PubMed 41706062Glaeser J, Lopez-Ayala P, Kellner C, Boeddinghaus J, Nestelberger T, Koechlin L, Sorensen NA, Haller PM, Bima P, Crisanti L, Spagnuolo CC, Strebel I, Hure G, Sieber S, Rubini Gimenez M, Wildi K, Wussler D, Miro O, Martin-Sanchez FJ, Keller DI, Christ M, Twerenbold R, Mahfoud F, Neumann J, Mueller C; APACE and BACC Investigators. Comparison of the European Society of Cardiology 0/1-Hour and High-Sensitivity Troponin in the Evaluation of Patients With Suspected Acute Coronary Syndrome 0/2-or-0/3-Hour Algorithms for Rapid Myocardial Infarction Diagnosis: A Prospective Multicenter Study. J Am Coll Cardiol. 2026 May 5;87(17):2261-2278. doi: 10.1016/j.jacc.2025.12.056. Epub 2026 Feb 18.
- Derived from this study: PubMed 40828180Haller PM, Schock A, Kellner C, Lehmacher J, Toprak B, Hartikainen TS, Kiss KM, Alhaou G, Peifer K, Twerenbold R, Zeller T, Westermann D, Neumann JT, Sorensen NA. Bedside echocardiography in patients with suspected acute myocardial infarction without ST elevation. Clin Res Cardiol. 2025 Aug 19. doi: 10.1007/s00392-025-02724-2. Online ahead of print.
- Derived from this study: PubMed 40021054Thiebetaen N, Pickering JW, Kellner C, Haller PM, Lehmacher J, Toprak B, Twerenbold R, Sorensen NA, Pemberton C, Troughton R, Richards AM, Sharif S, Worster A, Than M, Kavsak PA, Neumann JT. A Common Algorithm for Cardiac Troponin to Rule Out and Rule in Acute Myocardial Infarction. Can J Cardiol. 2025 Jul;41(7):1351-1360. doi: 10.1016/j.cjca.2025.02.029. Epub 2025 Feb 26.
- Derived from this study: PubMed 37982865Haller PM, Kellner C, Sorensen NA, Lehmacher J, Toprak B, Schock A, Hartikainen TS, Twerenbold R, Zeller T, Westermann D, Neumann JT. Long-term outcome of patients presenting with myocardial injury or myocardial infarction. Clin Res Cardiol. 2025 Jun;114(6):700-708. doi: 10.1007/s00392-023-02334-w. Epub 2023 Nov 20.
- Derived from this study: PubMed 37158171Haller PM, Sorensen NA, Hartikainen TS, Gossling A, Lehmacher J, Toprak B, Twerenbold R, Richter J, Banko T, Korschid S, Schmidt J, Keller T, Zeller T, Blankenberg S, Westermann D, Neumann JT. Rising and Falling High-Sensitivity Cardiac Troponin in Diagnostic Algorithms for Patients With Suspected Myocardial Infarction. J Am Heart Assoc. 2023 May 16;12(10):e027166. doi: 10.1161/JAHA.122.027166. Epub 2023 May 9.
- Derived from this study: PubMed 37131096Neumann JT, Twerenbold R, Ojeda F, Aldous SJ, Allen BR, Apple FS, Babel H, Christenson RH, Cullen L, Di Carluccio E, Doudesis D, Ekelund U, Giannitsis E, Greenslade J, Inoue K, Jernberg T, Kavsak P, Keller T, Lee KK, Lindahl B, Lorenz T, Mahler SA, Mills NL, Mokhtari A, Parsonage W, Pickering JW, Pemberton CJ, Reich C, Richards AM, Sandoval Y, Than MP, Toprak B, Troughton RW, Worster A, Zeller T, Ziegler A, Blankenberg S; ARTEMIS study group. Personalized diagnosis in suspected myocardial infarction. Clin Res Cardiol. 2023 Sep;112(9):1288-1301. doi: 10.1007/s00392-023-02206-3. Epub 2023 May 2.
- Derived from this study: PubMed 37048135von Haehling S, Muller-Hennessen M, Garfias-Veitl T, Gossling A, Neumann JT, Sorensen NA, Haller PM, Hartikainen T, Vollert JO, Mockel M, Blankenberg S, Westermann D, Giannitsis E. Role of Copeptin and hs-cTnT to Discriminate AHF from Uncomplicated NSTE-ACS with Baseline Elevated hs-cTnT-A Derivation and External Validation Study. Cells. 2023 Mar 31;12(7):1062. doi: 10.3390/cells12071062.
- Derived from this study: PubMed 36858602Lehmacher J, Neumann JT, Sorensen NA, Gossling A, Schmidt SE, Zeller T, Blankenberg S, Westermann D, Clemmensen PM. Diagnostic performance of a device for acoustic heart sound analysis in patients with suspected myocardial infarction. Open Heart. 2023 Mar;10(1):e002090. doi: 10.1136/openhrt-2022-002090.
- Derived from this study: PubMed 35174220Hartikainen TS, Gossling A, Sorensen NA, Lehmacher J, Neumann JT, Blankenberg S, Westermann D. Prognostic Implications of a Second Peak of High-Sensitivity Troponin T After Myocardial Infarction. Front Cardiovasc Med. 2022 Jan 31;8:780198. doi: 10.3389/fcvm.2021.780198. eCollection 2021.
- Individual participant dataSharing planned: Undecided
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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.
Johannes Neumann, MD principal investigator
UHZ
Nils Sörensen, MD principal investigator
UHZ
1 site 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 Syndrome and Myocardial Infarction, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johannes T Neumann, MD (0049407410 ext. 56800, j.neumann@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute myocardial infarction as index event (time frame: Months). 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 NCT02355457, which also lists 27 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 13 May 2024.