RecruitingPhase 4NCT05700877

Screening and Intervention for Subclinical Coronary Artery 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


Sponsor

Per Løgstrup Poulsen

Enrollment

7,300 participants

Start Date

Jan 12, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 55 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is checking whether doing a heart artery CT scan in people with type 2 diabetes can find hidden heart disease early — and whether certain diabetes medicines (SGLT2 inhibitors or GLP-1 analogs) can then lower the risk of a future heart attack or stroke. You may be eligible if: - You have been diagnosed with type 2 diabetes (new or existing) - You are a man between 55 and 69, or a woman between 60 and 74 years old - You have given signed consent to participate You may NOT be eligible if: - You have already had a heart attack, a heart procedure (like a stent or bypass surgery), heart failure, a stroke, or peripheral artery disease (blockage in the leg arteries) - You are allergic or have contraindications to both of the main drug classes being studied (SGLT2 inhibitors and GLP-1 analogs) - Your CT scan or heart ultrasound shows a very severe blockage (more than 50% in the main heart artery) or very weak heart function - You are not expected to live more than 1 year due to any medical condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERCAC-based treatment strategy

The intervention is a combination of screening with a heart CT scan and multifactorial intervention based on the screening results. Participants randomized to CAC-based treatment and with screening results showing high risk of CVD, will receive a multifactorial intervention including the combination of two open label investigational medical products: dapagliflozin 10mg/day and semaglutide 0.25 /week or 0.5 /week or 1.0 /week.

OTHERStandard treatment

Participants randomized to standard treatment are recommended to follow updated guidelines for CVD prevention.


Locations(1)

Odense University Hospital

Odense, Denmark

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NCT05700877


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