Screening and treatment for heart disease in patients with type 2 diabetes
Screening and Intervention for Subclinical Coronary Artery Disease in Patients With Type 2 Diabetes: THE STENO INTEN-CT STUDY
This study tests if screening for heart disease and adjusting treatment can help people with type 2 diabetes who don’t have heart problems feel better and stay healthier.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 7300 (estimated) |
| Ages | 55 Years to 75 Years |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 1 site (Odense) |
| Trial ID | NCT05700877 on ClinicalTrials.gov |
What this trial studies
This study investigates whether a combined screening and treatment strategy for cardiovascular disease (CVD) is beneficial for patients with type 2 diabetes who do not have known CVD. It aims to determine if patients identified as high-risk through coronary artery calcium (CAC) scoring benefit from intensified treatment, while also assessing the safety of reducing treatment intensity in low-risk patients. Additionally, the study will evaluate patient-reported health outcomes and cost-effectiveness of the interventions. The approach utilizes advanced noninvasive imaging techniques to assess coronary atherosclerosis.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 55-69 years for men and 60-74 years for women with a new or former diagnosis of type 2 diabetes.
Not a fit: Patients with a history of cardiovascular disease or critical cardiac conditions will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for patients with type 2 diabetes, potentially reducing cardiovascular events.
How similar studies have performed: Other studies have shown promise in using CAC scoring for risk stratification in cardiovascular disease, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * New or former diagnosis of Type 2 diabetes according to WHO. * Age between 55-69 years (men) and 60-74 years (women). * Signed declaration of consent Exclusion Criteria: * 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). * Contraindications or allergies to both SGLT2 inhibitors and GLP-1 analogues. * 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. * Expected life duration \< 1 year for any reason.
Where this trial is running
Odense
- Odense University Hospital — Odense, Denmark (Recruiting)
Study contacts
- Principal investigator: Per L Poulsen, Professor — Steno Diabetes Center Aarhus, AUH, and Aarhus University
- Study coordinator: Kristian L Funck, MD PhD
- Email: klf@clin.au.dk
- Phone: +4561331588
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.