NCT05046483 Metabolic Phenotyping and Follow-Up of Patients With and Without Diabetes After New Onset of STEMI
| NCT ID | NCT05046483 |
| Status | Recruiting |
| Phase | — |
| Sponsor | German Diabetes Center |
| Condition | ST-segment Elevation Myocardial Infarction (STEMI) |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2018-12-30 |
| Primary Completion | 2028-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2018-12-30 with a primary completion date of 2028-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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 & Investigator
Michael Roden, Prof., MD
PRINCIPAL INVESTIGATOR
German Diabetes Center
Frequently Asked Questions
Who can join the NCT05046483 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying ST-segment Elevation Myocardial Infarction (STEMI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05046483 currently recruiting?
Yes, NCT05046483 is actively recruiting participants. Contact the research team at michael.roden@ddz.de for enrollment information.
Where is the NCT05046483 trial being conducted?
This trial is being conducted at Düsseldorf, Germany.
Who is sponsoring the NCT05046483 clinical trial?
NCT05046483 is sponsored by German Diabetes Center. The principal investigator is Michael Roden, Prof., MD at German Diabetes Center. The trial plans to enroll 300 participants.