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NCT04146701 Clinical Trial

Metabolomics and Microbiomics in Cardiovascular Diseases

Sepsis Clinical Trial

— MEMORIA  

Official title:
Metabolomics and Microbiomics in Cardiovascular Diseases

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04146701
Other study ID # 2019-1093N-MA
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2019
Est. completion date December 31, 2022

Study information
Verified date February 2021
Source Universitätsmedizin Mannheim
Contact Michael Behnes, PD Dr.
Phone 0049 621 383 6239
Email michael.behnes@umm.de
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

"MEtabolomics and MicrObiomics in caRdIovAscular diseases Mannheim (MEMORIAM) " is a single-center, prospective and observational study investigating to identify disease-specific metabolic, respectively microbiomic, patterns of patients with high-risk cardiovascular diseases. High-risk cardiovascular diseases comprise patients suffering from acute heart failure (AHF), ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI), sepsis, septic shock, ischemic and non-ischemic cardiomyopathy.

Description:

Scientific evidence about the metabolomic and microbiomic changes in high-risk cardiovascular patients is still lacking. The acute, critical or progressive disease status predestinies to relevant changes in cardiovascular metobolism. High-risk patients in the present trial comprise those with acute heart failure, myocardial infarction (STEMI and NSTEMI), sepsis, septic shock, ischemic and non-ischemic cardiomyopathy with severely reduced left ventricular ejection fraction (LVEF <35%). Therfore this study investigates to identify disease-specific patterns of metabolic and microbiomic changes. These patterns may help to understand pathophysiology at the metabolic stages and find out those patients being at highest risk of adverse future outcome.

Recruitment information / eligibility
Status Recruiting
Enrollment 750
Est. completion date December 31, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - above mentioned diseases, diagnosis according to respective guideline - written informed consent Exclusion Criteria: - under 18 years - cancer - rheumatic diseases - infections (except septic group) - higher grade heart valve diseases

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Blood draw
venous blood withdraw (ca. 40ml)

Locations
Country Name City State
Germany University Medical Center Mannheim Mannheim

Sponsors (1)
Lead Sponsor Collaborator
Universitätsmedizin Mannheim

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Disease-specific metabolic/microbiomic biomarker patterns. Expression of disease-specific metabolic/microbiomic biomarker patterns at the time of acute disease presentation Within 24h after disease onset
Secondary All-cause and cardiovascular mortality. All-cause and cardiovascular mortality, at 6 months and 12 months 12 months after inclusion
Secondary Cardiac rehospitalization. Cardiac rehospitalization, at 6 months and 12 months. 12 months after inclusion
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