Systemic Organ Communication in STEMI

ST-segment Elevation Myocardial Infarction (STEMI) Clinical Trial

— SYSTEMI  

Official title:

Systemic Organ Communication in STEMI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03539133
• Other study ID #: 17-018
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• ST-segment Elevation Myocardial Infarction (STEMI)

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