- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03539133
Systemic Organ Communication in STEMI (SYSTEMI)
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Christian Jung, MD, PhD
- Phone Number: +492118118800
- Email: christian.jung@med.uni-duesseldorf.de
Study Contact Backup
- Name: Florian Bönner, MD,
- Phone Number: +492118118800
- Email: florian.boenner@med.uni-duesseldorf.de
Study Locations
-
-
-
Düsseldorf, Germany, 40225
- Recruiting
- Division of Cardiology, Pulmonary Disease and Vascular Medicine
-
Contact:
- Christian Jung, MD, PhD
-
Contact:
- Florian Bönner, MD
- Email: florian.boenner@med.uni-duesseldorf.de
-
Principal Investigator:
- Christian Jung, MD, PhD
-
Principal Investigator:
- Malte Kelm, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients suffering from STEMI
Exclusion Criteria:
- < 18 years
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Left-ventricular function
Time Frame: 6 months
|
|
6 months
|
|
Left-ventricular remodeling
Time Frame: 6 months
|
Δ LVEDV ≥ 20% or Δ LVESV ≥ 15% between day 5 of hospitalization and 6 months
|
6 months
|
|
Myocardial texture
Time Frame: on day 5 of hospitalization and 6 months
|
|
on day 5 of hospitalization and 6 months
|
|
Patency rate
Time Frame: 6 months
|
Coronary patency rate
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
All cause mortaltiy
Time Frame: 12 months
|
All cause mortaltiy
|
12 months
|
|
MACCE
Time Frame: 12 months
|
cardiovascular death, non-fatal stroke or myocardial infarction
|
12 months
|
|
Re-Hospitalisation due to heart failure
Time Frame: 12 months
|
Re-Hospitalisation due to heart failure
|
12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Christian Jung, MD, PhD, Division of Cardiology, Pulmonary Disease and Vascular Medicine
- Study Chair: Malte Kelm, MD, Division of Cardiology, Pulmonary Disease and Vascular Medicine
Publications and helpful links
General Publications
- Benkhoff 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.
- Bonner 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Pathologic Processes
- Heart Diseases
- Metabolic Diseases
- Glucose Metabolism Disorders
- Necrosis
- Hematologic Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Myocardial Ischemia
- Myocardial Infarction
- Ischemia
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Hemic and Lymphatic Diseases
- ST Elevation Myocardial Infarction
- Diabetes Mellitus
- Coronary Artery Disease
- Anemia
- Infarction
Other Study ID Numbers
- 17-018
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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