- 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 (Anticipated)
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
-
-
-
Duesseldorf, 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
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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 |
---|---|---|
MACCE (cardiovascular death, non-fatal stroke or myocardial infarction)
Time Frame: 12 months
|
MACCE (cardiovascular death, non-fatal stroke or myocardial infarction)
|
12 months
|
Rehospitalization due to heart failure
Time Frame: 12 months
|
Rehospitalization due to heart failure
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patency rate
Time Frame: 6 months
|
6 months
|
|
left ventricular enddiastolic volume index (LVEDVi)
Time Frame: 6 months
|
left ventricular enddiastolic volume as indexed on body surface area by either cardiovascular magnet resonance or echocardiography
|
6 months
|
Ejection fraction (%)
Time Frame: 6 months
|
Ejection fraction (%) indexed on body surface area measured by either cardiovascular magnet resonance or echocardiography
|
6 months
|
stroke volume
Time Frame: 6 months
|
stroke volume indexed on body surface area measured by either cardiovascular magnet resonance or echocardiography
|
6 months
|
Restenosis rate
Time Frame: 6 months
|
Percent of patients with restenosis
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Christian Jung, MD, PhD, Division of Cardiology, Pulmonary Disease and Vascular Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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