Screening and Intervention for Subclinical Coronary Artery Disease in Patients With Type 2 Diabetes: THE STENO INTEN-CT STUDY

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The investigators intend to perform a landmark study to answer whether a combined CVD screening and treatment strategy is beneficial for patients with type 2 diabetes (T2DM) without known cardiovascular disease (CVD) The investigators aim to answer the following main research questions: Do screening detected high-risk patients benefit of intensified medical treatment? Is it safe to de-intensify medical treatment among patients with a screening detected low risk of CVD? Does a CVD screening and treatment program improve patient reported health status? Cardiovascular risk remains high in patients with T2DM but unevenly distributed. Our current risk stratification strategies are far from optimal leading to both under- and over-treatment of patients. In recent years, noninvasive imaging of subclinical coronary artery disease by cardiac CT has improved considerably. This allows for easily accessible evaluations of coronary atherosclerosis burden and composition - exceptionally strong imaging biomarkers of future cardiovascular disease. An increasing amount of data suggests that cardiac CT may permit better risk stratification in patients with T2DM. At the same time, the pharmaceutical treatment of T2DM has changed with several new and expensive drug classes, each individually documented to reduce the risk for new or recurrent cardiovascular events. Thus, these new drugs may improve outcome in high-risk patients, whereas they may be wasteful and only lead to side effects in low-risk patients. In the Inten-CT study, the investigators combine these two pivotal developments. The investigators intend to improve risk stratification of patients with T2DM by use of cardiac CT and, based on this knowledge, the investigators wish to investigate if upgraded medical treatment in the high-risk population is beneficial and if de-intensified treatment in the low-risk population is safe. As a secondary aim, the investigators wish to investigate if such a strategy improves patient reported health status. These aims are in agreement with one of the important health indicators from The Danish College of General Practitioners: We find and treat the patients and let the healthy stay healthy. The investigators intend with this strategy to improve not only cardiovascular outcome among patients with T2DM, but also their quality of life. The Inten-CT study is an investigator-initiated open-label event-driven randomized controlled trial including patients with T2DM stratified according to screen detected coronary artery calcification. The investigators expect inclusion of 7300 patients in 2 years and a mean follow-up period of 5 years.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Odense University Hospital
RECRUITING
Odense
Contact Information
Primary
Kristian L Funck, MD PhD
klf@clin.au.dk
+4561331588
Backup
Per L Poulsen, Professor
perpouls@rm.dk
Time Frame
Start Date: 2023-01-12
Estimated Completion Date: 2029-03-01
Participants
Target number of participants: 7300
Treatments
Experimental: CAC-based treatment
Patients randomized to CAC-based treatment, will be stratified into low- or high-risk patients (defined by CAC score=0 or ≥ 100), and hence, allocated to two parallel l clinical studies.~High-risk patients (CAC≥ 100) in the CAC-based treatment group will be included in a study in which they will receive information on CAC-score, mandatory treatment with dapagliflozin and semaglutide (both study drugs), and advise on further multifactorial treatment of blood lipid levels, blood pressure and antithrombotic therapy.~Low-risk patients (CAC=0) will be included in a study in which they will receive information on CAC-score and advise on how multifactorial treatment may be de-intensified.
Other: Standard treatment
Patients randomized to standard treatment and their primary physician are not informed about the screening findings. Patients are encouraged to follow contemporary diabetes guidelines at the time of inclusion. This information will be given in a written letter within a week of randomization.
Sponsors
Leads: Per Løgstrup Poulsen
Collaborators: Odense University Hospital

This content was sourced from clinicaltrials.gov