ST-segment Elevation Myocardial Infarction (STEMI)SYSTEMINCT03539133
Systemic Organ Communication in STEMI
An observational study of ST-segment Elevation Myocardial Infarction (STEMI), run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
Despite progress in pre-hospital care, ambulance logistics, pharmacotherapy and PPCI techniques, ST-segment elevation myocardial infarction (STEMI) continues to confer a substantial burden of morbidity and mortality. Within the STEMI population, there is a spectrum of higher and lower risk patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST-segment Elevation Myocardial Infarction (STEMI)
- What is being tested?
- collection of clinical data
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 18 Oct 2017to Jun 2030
- 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: Patients suffering from STEMI
Who may be able to join
- Patients suffering from STEMI
Who cannot join
- < 18 years
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
Division of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, 40225
Christian Jung, MD, PhD
Florian Bönner, MD, florian.boenner@med.uni-duesseldorf.de
About this study
Despite progress in pre-hospital care, ambulance logistics, pharmacotherapy and PPCI techniques, ST-segment elevation myocardial infarction (STEMI) continues to confer a substantial burden of morbidity and mortality.
Within the STEMI population, there is a spectrum of higher and lower risk patients. The aim of this cohort study is to collect prospectively and systematically clinical research data from STEMI patients. This cohort study is an open-end observational study to identify master switches in myocardial ischemia.
- Being tested
- collection of clinical data
- Keywords
- STEMI, infarction, coronary artery disease, comorbidities, diabetes, anemia
- Medical subject headings
- ST Elevation Myocardial Infarction, Infarction, Coronary Artery Disease, Diabetes Mellitus, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of clinical dataOther
prospectively and systematically collection of clinical research data from STEMI patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Left-ventricular function
- LV-EF < 40% at 6 months
- Δ LV-EF ≥ 5% between day 5 of hospitalization and 6 months
Measured: 6 months
Left-ventricular remodeling
Δ LVEDV ≥ 20% or Δ LVESV ≥ 15% between day 5 of hospitalization and 6 months
Measured: 6 months
Myocardial texture
- Infarct/Scar size > 17.9% or MVO (yes) or IMH (yes) on day 5 of hospitalization or at 6 months
- remote zone ΔECV between day 5 of hospitalization and 6 months
Measured: on day 5 of hospitalization and 6 months
Patency rate
Coronary patency rate
Measured: 6 months
Secondary outcomes (3)
All cause mortaltiy
All cause mortaltiy
Measured: 12 months
MACCE
cardiovascular death, non-fatal stroke or myocardial infarction
Measured: 12 months
Re-Hospitalisation due to heart failure
Re-Hospitalisation due to heart failure
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start18 Oct 2017
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ST-segment Elevation Myocardial Infarction (STEMI)Studies of the same condition, open and under way.
- 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Jung, MD, PhD, Principal investigator, Division of Cardiology, Pulmonary Disease and Vascular MedicineMalte Kelm, MD, Study chair, Division of Cardiology, Pulmonary Disease and Vascular Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539133
- Sponsor's protocol ID
- 17-018
- Acronym
- SYSTEMI
- Status last verified
- Jan 2026
- First submitted
- 3 May 2018
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Helten C, Benkhoff M, Mourikis P, Metzen D, Barcik M, Hu H, Ayhan A, Haurand J, Alde K, Duse D, Jung C, Hohlfeld T, Levkau B, Petzold T, Borst O, Becher S, Ommer-Blaesius M, Witkowski S, Lang A, Cramer M, Dannenberg L, Kelm M, Gerdes N, Polzin A. Acetylsalicylic acid improves outcome after acute myocardial infarction by reducing thromboinflammation. J Thromb Haemost. 2026 Jun;24(6):2273-2292. doi: 10.1016/j.jtha.2026.02.003. Epub 2026 Mar 4.
PubMed 41791655Benkhoff M, Alde K, Ehreiser V, Dahlmanns J, Metzen D, Haurand JM, Duse DA, Jung C, Kelm M, Petzold T, Polzin A. Thromboinflammation is associated with clinical outcome after ST-elevation myocardial infarction. Blood Adv. 2024 Nov 12;8(21):5581-5589. doi: 10.1182/bloodadvances.2024014273.
PubMed 39226457Bonner F, Jung C, Polzin A, Erkens R, Dannenberg L, Ipek R, Kaldirim M, Cramer M, Wischmann P, Zaharia OP, Meyer C, Flogel U, Levkau B, Godecke A, Fischer J, Klocker N, Kruger M, Roden M, Kelm M. SYSTEMI - systemic organ communication in STEMI: design and rationale of a cohort study of patients with ST-segment elevation myocardial infarction. BMC Cardiovasc Disord. 2023 May 3;23(1):232. doi: 10.1186/s12872-023-03210-1.
PubMed 37138228
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Organ Communication in STEMI
- ClinicalTrials.gov ID
- NCT03539133
- Acronym / sponsor ID
- SYSTEMI / 17-018
- Keywords
- STEMI, infarction, coronary artery disease, comorbidities, diabetes, anemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 18 Oct 2017 (actual)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 29 May 2018 (actual)
- 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.
Despite progress in pre-hospital care, ambulance logistics, pharmacotherapy and PPCI techniques, ST-segment elevation myocardial infarction (STEMI) continues to confer a substantial burden of morbidity and mortality.
Within the STEMI population, there is a spectrum of higher and lower risk patients. The aim of this cohort study is to collect prospectively and systematically clinical research data from STEMI patients. This cohort study is an open-end observational study to identify master switches in myocardial ischemia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from STEMI
Key inclusion criteria (1 listed)
- Patients suffering from STEMI
Key exclusion criteria (1 listed)
- < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collection of clinical dataprospectively and systematically collection of clinical research data from STEMI patients | Other | – |
Primary outcome
Left-ventricular function
Time frame: 6 months
* LV-EF < 40% at 6 months * Δ LV-EF ≥ 5% between day 5 of hospitalization and 6 months
Left-ventricular remodeling
Time frame: 6 months
Δ LVEDV ≥ 20% or Δ LVESV ≥ 15% between day 5 of hospitalization and 6 months
Myocardial texture
Time frame: on day 5 of hospitalization and 6 months
* Infarct/Scar size > 17.9% or MVO (yes) or IMH (yes) on day 5 of hospitalization or at 6 months * remote zone ΔECV between day 5 of hospitalization and 6 months
Patency rate
Time frame: 6 months
Coronary patency rate
3 secondary outcomes
All cause mortaltiy
Time frame: 12 months
MACCE
Time frame: 12 months
Re-Hospitalisation due to heart failure
Time frame: 12 months
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 22 Jan 2026.
- Derived from this study: PubMed 41791655Helten C, Benkhoff M, Mourikis P, Metzen D, Barcik M, Hu H, Ayhan A, Haurand J, Alde K, Duse D, Jung C, Hohlfeld T, Levkau B, Petzold T, Borst O, Becher S, Ommer-Blaesius M, Witkowski S, Lang A, Cramer M, Dannenberg L, Kelm M, Gerdes N, Polzin A. Acetylsalicylic acid improves outcome after acute myocardial infarction by reducing thromboinflammation. J Thromb Haemost. 2026 Jun;24(6):2273-2292. doi: 10.1016/j.jtha.2026.02.003. Epub 2026 Mar 4.
- Derived from this study: PubMed 39226457Benkhoff M, Alde K, Ehreiser V, Dahlmanns J, Metzen D, Haurand JM, Duse DA, Jung C, Kelm M, Petzold T, Polzin A. Thromboinflammation is associated with clinical outcome after ST-elevation myocardial infarction. Blood Adv. 2024 Nov 12;8(21):5581-5589. doi: 10.1182/bloodadvances.2024014273.
- Derived from this study: PubMed 37138228Bonner F, Jung C, Polzin A, Erkens R, Dannenberg L, Ipek R, Kaldirim M, Cramer M, Wischmann P, Zaharia OP, Meyer C, Flogel U, Levkau B, Godecke A, Fischer J, Klocker N, Kruger M, Roden M, Kelm M. SYSTEMI - systemic organ communication in STEMI: design and rationale of a cohort study of patients with ST-segment elevation myocardial infarction. BMC Cardiovasc Disord. 2023 May 3;23(1):232. doi: 10.1186/s12872-023-03210-1.
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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.
Christian Jung, MD, PhD principal investigator
Division of Cardiology, Pulmonary Disease and Vascular Medicine
Malte Kelm, MD study chair
Division of Cardiology, Pulmonary Disease and Vascular Medicine
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 ST-segment Elevation Myocardial Infarction (STEMI), run by Heinrich-Heine University, Duesseldorf 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 1 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 22 Jan 2026. 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 Christian Jung, MD, PhD (+492118118800, christian.jung@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left-ventricular function (time frame: 6 months). The study lists 4 primary outcomes in all. 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 NCT03539133, which also lists 3 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 22 Jan 2026.