NCT05046483Recruiting
Metabolic Phenotyping and Follow-Up of Patients With and Without Diabetes After New Onset of STEMI
Metabolic Phenotyping and Follow-Up of Patients With and Without Diabetes Mellitus After New Onset of ST-Segment Elevation Myocardial Infarction (STEMI) (DISTEMI Study)
Source: ClinicalTrials.gov · Last updated 22 Aug 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 7 Sept 2021
- Start date
- 30 Dec 2018
- Primary completion date
- 30 Dec 2028
- Lead sponsor
- German Diabetes Center
- NCT number
- NCT05046483
What you commit to
- Study type: Observational
- Planned participants: 300
- From 30 Dec 2018 to the primary completion date, 30 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Immunosuppressive therapy
Other illness
- Diabetes mellitus category 3 A-H (ADA criteria), gestational diabetes
- Infectious diseases, acute infections / fever
- Malignant diseases
- Severe chronic psychiatric illness or addiction
Lab values
- Severe chronic renal, liver or heart disease (e.g. serum creatinin ≥1.6 mg/dl, peripheral artery occlusive disease stage IV)
Other
- Current pregnancy
- Participation in an intervention trial
Who the study is looking for
- 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)
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| German Diabetes Center Coordinator of this site? Confirm its status | Düsseldorf | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.