Metabolomics and Microbiomics in Cardiovascular Diseases

NCT04146701 | Unknown

• 1 other identifier: 2019-1093N-MA
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• All-cause and cardiovascular mortality.

  12 months after inclusion

• Cardiac rehospitalization.

  12 months after inclusion

Study Arms (7)

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

Blood draw OTHER

venous blood withdraw (ca. 40ml)

Acute heart failure; Healthy controls; Ischemic cardiomyopathy; NSTEMI; Non-ischemic cardiomyopathy; STEMI; Sepsis

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universitätsmedizin Mannheim: lead

Study Sites (1)

University Medical Center Mannheim

Mannheim, 68167, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Withdrawl of peripheral venous blood (ca. 40ml) in EDTA, and ammonium heparin serum tubes at the time of acute disease status.

MeSH Terms

Conditions

Non-ST Elevated Myocardial Infarction; ST Elevation Myocardial Infarction; Myocardial Infarction; Sepsis; Cardiomyopathies; Cardiomyopathy, Dilated

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Cardiomegaly; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Michael Behnes, PD Dr.

  University Medical Center Mannheim

  STUDY DIRECTOR

Central Study Contacts

Michael Behnes, PD Dr.

CONTACT

0049 621 383 6239; michael.behnes@umm.de

Ibrahim Akin, Prof. Dr.

CONTACT

0049 621 383 5229; ibrahim.akin@umm.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician, adjunct professor

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: October 31, 2019
• Study Start: February 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: February 16, 2021

Record last verified: 2021-02

Locations

DE (1)