2022-500143-21-01Active, not recruitingPhase 4
Screening and intervention for subclinical coronary artery disease in patients with type 2 diabetes: THE STENO INTEN-CT STUDY
Source: EU CTIS (euclinicaltrials.eu) · Last updated 20 Sept 2024
Brief summary (registry, in English)
In type 2 diabetes patients and no known cardiovascular disease, we aim to evaluate the possible cardiovascular benefit of a treatment strategy based on a heart CT scan.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 7300 (estimated)
- First submitted
- 20 May 2022
- Start date
- 12 Jan 2023
- Lead sponsor
- Aarhus University Hospital
- Diseases
- Type 2 diabetes
- EU CT number
- 2022-500143-21-01
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 7300
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous history of CVD (previous myocardial infarction or coronary intervention (percutaneous coronary intervention or by-pass), heart failure, stroke or peripheral artery disease as documented by the patient or the patient medical record).
Other illness
- Contraindications or allergies to both SGLT2 inhibitors and GLP-1 analogues.
Lab values
- Signs of critical cardiac disease: >50% stenosis of left main coronary artery (CT angiography) or left ventricular ejection fraction below 30% (echocardiography). If a CT angiography is not available, a CAC>1000 on the non-contrast cardiac CT will be considered equal to critical cardiac disease.
Other
- Expected life duration < 1 year for any reason.
Who the study is looking for
- New or former diagnosis of T2DM according to WHO.
- Age between 55-69 years (men) and 60-74 years (women).
- Signed declaration of consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aalborg University Hospital | Aalborg | Denmark | Active, not recruiting |
| Aarhus University Hospital | Aarhus N | Denmark | Active, not recruiting |
| Sydvestjysk Sygehus | Esbjerg | Denmark | Active, not recruiting |
| Steno Diabetes Center Copenhagen | Herlev | Denmark | Active, not recruiting |
| Region Midtjylland | Herning | Denmark | Active, not recruiting |
| Nordsjaellands Hospital | Hilleroed | Denmark | Active, not recruiting |
| Holbaek Sygehus | Holbæk | Denmark | Active, not recruiting |
| Lillebaelt Hospital | Kolding | Denmark | Active, not recruiting |
| Nykoebing F Sygehus | Nykobing F | Denmark | Active, not recruiting |
| Odense University Hospital | Odense C | Denmark | Active, not recruiting |
| Region Midtjylland | Silkeborg | Denmark | Active, not recruiting |
| Odense University Hospital | Svendborg | Denmark | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.