Metabolomics and Microbiomics in Cardiovascular Diseases

NCT ID: NCT04146701

Last Updated: 2021-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-01

Study Completion Date

2022-12-31

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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Acute heart failure

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.

Blood draw

Intervention Type OTHER

venous blood withdraw (ca. 40ml)

STEMI

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.

Blood draw

Intervention Type OTHER

venous blood withdraw (ca. 40ml)

NSTEMI

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.

Blood draw

Intervention Type OTHER

venous blood withdraw (ca. 40ml)

Ischemic cardiomyopathy

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.

Blood draw

Intervention Type OTHER

venous blood withdraw (ca. 40ml)

Non-ischemic cardiomyopathy

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.

Blood draw

Intervention Type OTHER

venous blood withdraw (ca. 40ml)

Sepsis

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.

Blood draw

Intervention Type OTHER

venous blood withdraw (ca. 40ml)

Healthy controls

Clinically inapparent group as controls. One venous blood withdraw will be performed. Demographic and clinical data will be documented.

Blood draw

Intervention Type OTHER

venous blood withdraw (ca. 40ml)

Interventions

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Blood draw

venous blood withdraw (ca. 40ml)

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitätsmedizin Mannheim

OTHER

Sponsor Role lead

Responsible Party

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Michael Behnes

Attending physician, adjunct professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Behnes, PD Dr.

Role: STUDY_DIRECTOR

University Medical Center Mannheim

Locations

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University Medical Center Mannheim

Mannheim, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Michael Behnes, PD Dr.

Role: CONTACT

0049 621 383 6239

Ibrahim Akin, Prof. Dr.

Role: CONTACT

0049 621 383 5229

Facility Contacts

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Akin Ibrahim, Prof. Dr.

Role: primary

0049 621 383 5229

Other Identifiers

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2019-1093N-MA

Identifier Type: -

Identifier Source: org_study_id

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