Metabolomics and Microbiomics in Cardiovascular Diseases

Study Overview
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Brief Summary
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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
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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.

Official Title
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Metabolomics and Microbiomics in Cardiovascular Diseases

Conditions
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Sepsis, Acute Heart Failure, NSTEMI - Non-ST Segment Elevation MI, STEMI - ST Elevation Myocardial Infarction, Myocardial Infarction, Acute, Cardiomyopathies, Dilated Cardiomyopathy, Ischemic Cardiomyopathy

Intervention / Treatment
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* Other: Blood draw


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute heart failure<br>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. | Other: Blood draw<br>* venous blood withdraw (ca. 40ml)<br>|
| STEMI<br>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. | Other: Blood draw<br>* venous blood withdraw (ca. 40ml)<br>|
| NSTEMI<br>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. | Other: Blood draw<br>* venous blood withdraw (ca. 40ml)<br>|
| Ischemic cardiomyopathy<br>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. | Other: Blood draw<br>* venous blood withdraw (ca. 40ml)<br>|
| Non-ischemic cardiomyopathy<br>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. | Other: Blood draw<br>* venous blood withdraw (ca. 40ml)<br>|
| Sepsis<br>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. | Other: Blood draw<br>* venous blood withdraw (ca. 40ml)<br>|
| Healthy controls<br>Clinically inapparent group as controls. One venous blood withdraw will be performed. Demographic and clinical data will be documented. | Other: Blood draw<br>* venous blood withdraw (ca. 40ml)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause and cardiovascular mortality. | All-cause and cardiovascular mortality, at 6 months and 12 months | 12 months after inclusion | 
| Cardiac rehospitalization. | Cardiac rehospitalization, at 6 months and 12 months. | 12 months after inclusion |