Metabolomics and Microbiomics in Cardiovascular Diseases (MEMORIA)

February 11, 2021 updated by: Michael Behnes, Universitätsmedizin Mannheim
"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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

750

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

  • Germany
      • Mannheim, Germany, 68167
        • Recruiting
        • University Medical Center Mannheim
        • Contact:

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 to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients suffering from acute cardiovascular diseases such as acute heart failure, STEMI, NSTEMI, ischemic and dilative cardiomyopathies and sepsis.

Description

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 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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Blood draw
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.
Other: Blood draw
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.
Other: Blood draw
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.
Other: Blood draw
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.
Other: Blood draw
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.
Other: Blood draw
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.
Other: Blood draw
venous blood withdraw (ca. 40ml)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-specific metabolic/microbiomic biomarker patterns.
Time Frame: Within 24h after disease onset
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.
Time Frame: 12 months after inclusion
All-cause and cardiovascular mortality, at 6 months and 12 months
12 months after inclusion
Cardiac rehospitalization.
Time Frame: 12 months after inclusion
Cardiac rehospitalization, at 6 months and 12 months.
12 months after inclusion

Collaborators and Investigators

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

Sponsor

Universitätsmedizin Mannheim

Investigators

  • Study Director: Michael Behnes, PD Dr., University Medical Center Mannheim

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)

February 1, 2019

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

October 29, 2019

First Submitted That Met QC Criteria

October 30, 2019

First Posted (Actual)

October 31, 2019

Study Record Updates

Last Update Posted (Actual)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 11, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-1093N-MA

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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