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

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients suffering from STEMI

Description

Inclusion Criteria:

  • Patients suffering from STEMI

Exclusion Criteria:

  • < 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Christian Jung, MD, PhD, Division of Cardiology, Pulmonary Disease and Vascular Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2017

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

May 3, 2018

First Submitted That Met QC Criteria

May 25, 2018

First Posted (Actual)

May 29, 2018

Study Record Updates

Last Update Posted (Actual)

May 5, 2022

Last Update Submitted That Met QC Criteria

May 4, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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