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Status unknownNCT04146701MEMORIAUpdated Feb 16, 2021

Metabolomics and Microbiomics in Cardiovascular Diseases

An observational study in Acute Heart Failure, NSTEMI - Non-ST Segment Elevation MI and STEMI - ST Elevation Myocardial Infarction, sponsored by Universitätsmedizin Mannheim. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-16.

Sponsored by Universitätsmedizin Mannheim · Observational

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
750
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Acute Heart Failure
  • NSTEMI - Non-ST Segment Elevation MI
  • STEMI - ST Elevation Myocardial Infarction
  • Myocardial Infarction, Acute
  • Sepsis
  • Cardiomyopathies
  • Dilated Cardiomyopathy
  • Ischemic Cardiomyopathy
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's planned enrollment of 750 is above the median of 573 across 1,485 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Universitätsmedizin Mannheim is the lead sponsor of 75 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Inclusion criteria

  • above mentioned diseases, diagnosis according to respective guideline
  • written informed consent

Exclusion criteria

Exclusion Criteria:

  • under 18 years
  • cancer
  • rheumatic diseases
  • infections (except septic group)
  • higher grade heart valve diseases
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
750 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • Healthy controls

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

    Other: Blood draw

Interventions

  • OtherBlood draw

    venous blood withdraw (ca. 40ml)

06

What researchers measure

Primary outcomes

  1. Disease-specific metabolic/microbiomic biomarker patterns.

    Expression of disease-specific metabolic/microbiomic biomarker patterns at the time of acute disease presentation

    Time frame: Within 24h after disease onset

Secondary outcomes

  1. All-cause and cardiovascular mortality.

    All-cause and cardiovascular mortality, at 6 months and 12 months

    Time frame: 12 months after inclusion

  2. Cardiac rehospitalization.

    Cardiac rehospitalization, at 6 months and 12 months.

    Time frame: 12 months after inclusion

07

Study locations

1 of 1 sites recruiting
  • University Medical Center Mannheim
    Mannheim, 68167, Germany
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04146701
Lead sponsor
Universitätsmedizin Mannheim
Responsible party
Michael Behnes (Attending physician, adjunct professor, Universitätsmedizin Mannheim) — Principal investigator
First posted
Oct 31, 2019
Start date
Feb 1, 2019
Primary completion
Dec 31, 2021 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Feb 16, 2021

Study contacts

Michael Behnes, PD Dr.
Contact
michael.behnes@umm.de
0049 621 383 6239
Ibrahim Akin, Prof. Dr.
Contact
ibrahim.akin@umm.de
0049 621 383 5229
Michael Behnes, PD Dr.
study director · University Medical Center Mannheim

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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