Metabolomics and Microbiomics in Cardiovascular Diseases

• Conditions: NSTEMI - Non-ST Segment Elevation MI; STEMI - ST Elevation Myocardial Infarction; Sepsis; Cardiomyopathies; Acute Heart Failure; Myocardial Infarction, Acute; Dilated Cardiomyopathy; Ischemic Cardiomyopathy
• Interventions: Other: Blood draw

• Registration Number: NCT04146701
• Lead Sponsor: Universitätsmedizin Mannheim

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2019-10-29
• Study First Submitted QC: 2019-10-30
• Study First Posted: 2019-10-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-11
• Last Update Posted: 2021-02-16
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 750

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sepsis	Blood draw	All consecutive patients admitted with sepsis or septic shock to University Medical Center Mannheim. One venous blood withdraw will be performed. Demographic and clinical data will be documented.
Healthy controls	Blood draw	Clinically inapparent group as controls. One venous blood withdraw will be performed. Demographic and clinical data will be documented.
Acute heart failure	Blood draw	All consecutive patients admitted with acute heart failure to University Medical Center Mannheim. One venous blood withdraw will be performed. Demographic and clinical data will be documented.
STEMI	Blood draw	All consecutive patients admitted with STEMI to University Medical Center Mannheim. One venous blood withdraw will be performed. Demographic and clinical data will be documented.
NSTEMI	Blood draw	All consecutive patients admitted with NSTEMI to University Medical Center Mannheim. One venous blood withdraw will be performed. Demographic and clinical data will be documented.
Ischemic cardiomyopathy	Blood draw	All consecutive patients with an implantable cardioverter defibrillator (ICD) due to ischemic cardiomyopathy and LVEF \<35% presenting for ICD check-up to University Medical Center Mannheim. One venous blood withdraw will be performed. Demographic and clinical data will be documented.
Non-ischemic cardiomyopathy	Blood draw	All consecutive patients with an implantable cardioverter defibrillator (ICD) due to non-ischemic cardiomyopathy and LVEF \<35% presenting for ICD check-up to University Medical Center Mannheim. One venous blood withdraw will be performed. Demographic and clinical data will be documented.

Primary Outcome Measures

Name	Time	Method
Disease-specific metabolic/microbiomic biomarker patterns.	Within 24h after disease onset	Expression of disease-specific metabolic/microbiomic biomarker patterns at the time of acute disease presentation

Secondary Outcome Measures

Name	Time	Method
All-cause and cardiovascular mortality.	12 months after inclusion	All-cause and cardiovascular mortality, at 6 months and 12 months
Cardiac rehospitalization.	12 months after inclusion	Cardiac rehospitalization, at 6 months and 12 months.

Trial Locations

Locations (1)

University Medical Center Mannheim; 🇩🇪 Mannheim, Germany