NCT05046483

Brief Summary

The aim of the prospective observational DISTEMI-Study in people with and without Diabetes mellitus (DI) after new onset of ST-Segment Elevation Myocardial Infarction (STEMI) aged 18-80 years at inclusion into the study is to characterize in detail the clinical, metabolical, immunological and vascular phenotype, investigate the interplay between myocardial remodelling and the metabolic phenotype, monitor the progression of the disease and compare the phenotype of STEMI people with diabetes mellitus to people with prediabetes and glucose tolerant people.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
44mo left

Started Dec 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Dec 2018Dec 2029

Study Start

First participant enrolled

December 30, 2018

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 16, 2021

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2029

Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

10 years

First QC Date

September 7, 2021

Last Update Submit

August 17, 2023

Conditions

ST-segment Elevation Myocardial Infarction (STEMI)Diabetes MellitusInsulin ResistanceNon-Alcoholic Fatty Liver Disease

Keywords

ST-segment elevation myocardial infarctionSTEMICardiovascular diseasesCVDDiabetes mellitusNormal glucose toleranceNon-alcoholic fatty liver diseaseNAFLDLiver fibrosis

Outcome Measures

Primary Outcomes (1)

  • Change of cardiac function

    Measurement of left-ventricular ejection fraction by cardiac magnetic resonance (MR) imaging

    One year

Secondary Outcomes (9)

  • Change of insulin sensitivity (M-Value)

    One year

  • Change of insulin secretion

    One year

  • Change of ectopic fat distribution

    One year

  • Change of liver stiffness

    One year

  • Change of energy metabolism

    One year

  • +4 more secondary outcomes

Study Arms (3)

Cohort with type 1 diabetes (T1D) and type 2 diabetes (T2D)

Prospectively followed cohort of people with new onset of ST-segment elevation myocardial infarction and diabetes mellitus (type 1 or type 2) according to the American Diabetes Association (ADA) and German Diabetes Society (DDG) criteria (HbA1c ≥6.5% or pathological oral glucose tolerance test (OGTT)), aged 18-80 years at inclusion into the study

Cohort of normal glucose tolerant people (NGT)

Prospectively followed cohort of healthy people with new onset of ST-elevation myocardial infarction and normal glucose tolerance status (HbA1c \<5.7% and normal OGTT), aged 18-80 years at inclusion into the study

Cohort of people with impaired glucose metabolism (IGM)

Prospectively followed cohort of people with new onset of ST-elevation myocardial infarction and impaired glucose metabolism, usually called prediabetes including impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) and/or HbA1c 5.7-6.4%, aged 18-80 years at inclusion into the study

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Maximum care hospital: Department of Cardiology, Pumonology and Vascular Medicine at University Hospital Düsseldorf (UKD), Heinrich Heine University (HHU), Düsseldorf. People with STEMI are recruited by screening at the German Diabetes Center (GDC/DDZ), Institute for Clinical Diabetology, Leibniz Institute for Diabetes Research at HHU Düsseldorf.

You may qualify if:

  • Condition after new onset of ST-segment elevation myocardial infarction (STEMI)
  • Age 18-80 years
  • HbA1c \<9.0%
  • People with diagnosis of diabetes mellitus according to ADA and DDG criteria (i.e. HbA1c ≥6.5% and/or pathological oral glucose tolerance test)
  • Healthy people with normal glucose tolerance status according to ADA and DDG criteria (i.e. HbA1c \<5.7% and normal OGTT)
  • People with impaired glucose metabolism ("prediabetes") according to ADA and DDG criteria (i.e. impaired fasting glucose and/or impaired glucose tolerance and/or HbA1c 5.7-6.4%)
  • Consent-able, hemodynamically stable people, without sedation (e.g. opiates) or other interfering medication (e.g. catecholamines)

You may not qualify if:

  • Diabetes mellitus category 3 A-H (ADA criteria), gestational diabetes
  • Current pregnancy
  • Infectious diseases, acute infections / fever
  • Immunosuppressive therapy
  • Severe chronic renal, liver or heart disease (e.g. serum creatinin ≥1.6 mg/dl, peripheral artery occlusive disease stage IV)
  • Malignant diseases
  • Severe chronic psychiatric illness or addiction
  • Participation in an intervention trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

German Diabetes Center

Düsseldorf, North Rhine-Westphalia, 40225, Germany

RECRUITING

Related Publications (1)

  • Heilmann G, Trenkamp S, Moser C, Bombrich M, Schon M, Yurchenko I, Strassburger K, Rodriguez MM, Zaharia OP, Burkart V, Wagner R, Roden M. Precise glucose measurement in sodium fluoride-citrate plasma affects estimates of prevalence in diabetes and prediabetes. Clin Chem Lab Med. 2023 Oct 24;62(4):762-769. doi: 10.1515/cclm-2023-0770. Print 2024 Mar 25.

    PMID: 37870928DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole-blood, peripheral blood mononuclear cells, serum, plasma, urine, stool

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionDiabetes MellitusInsulin ResistanceNon-alcoholic Fatty Liver DiseaseCardiovascular DiseasesLiver Cirrhosis

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinismFatty LiverLiver DiseasesDigestive System DiseasesFibrosis

Study Officials

  • Michael Roden, Prof., MD

    German Diabetes Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Roden, Prof., MD

CONTACT

+49-211-3382-0michael.roden@ddz.de

Clara Möser, MD

CONTACT

+49-211-3382-0clara.moeser@ddz.de

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2021

First Posted

September 16, 2021

Study Start

December 30, 2018

Primary Completion (Estimated)

December 30, 2028

Study Completion (Estimated)

December 30, 2029

Last Updated

August 22, 2023

Record last verified: 2023-08

Locations

DE(1)