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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03539133
Other study ID # 17-018
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 18, 2017
Est. completion date June 2023

Study information

Verified date May 2022
Source Heinrich-Heine University, Duesseldorf
Contact Christian Jung, MD, PhD
Phone +492118118800
Email christian.jung@med.uni-duesseldorf.de
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date June 2023
Est. primary completion date June 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients suffering from STEMI Exclusion Criteria: - < 18 years

Study Design


Related Conditions & MeSH terms


Intervention

Other:
collection of clinical data
prospectively and systematically collection of clinical research data from STEMI patients

Locations

Country Name City State
Germany Division of Cardiology, Pulmonary Disease and Vascular Medicine Duesseldorf

Sponsors (1)

Lead Sponsor Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary MACCE (cardiovascular death, non-fatal stroke or myocardial infarction) MACCE (cardiovascular death, non-fatal stroke or myocardial infarction) 12 months
Primary Rehospitalization due to heart failure Rehospitalization due to heart failure 12 months
Secondary Patency rate 6 months
Secondary left ventricular enddiastolic volume index (LVEDVi) left ventricular enddiastolic volume as indexed on body surface area by either cardiovascular magnet resonance or echocardiography 6 months
Secondary Ejection fraction (%) Ejection fraction (%) indexed on body surface area measured by either cardiovascular magnet resonance or echocardiography 6 months
Secondary stroke volume stroke volume indexed on body surface area measured by either cardiovascular magnet resonance or echocardiography 6 months
Secondary Restenosis rate Percent of patients with restenosis 6 months
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