Screening and Intervention for Subclinical Coronary Artery Disease in Patients With Type 2 Diabetes: THE STENO INTEN-CT STUDY
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 7,300
- 试验地点
- 2
- 主要终点
- Rates of a composite cardiovascular endpoint
研究概览
简要总结
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.
详细描述
HYPOTHESES Intensified multifactorial treatment is superior to standard treatment in patients with CAC score ≥100.
Less intensive multifactorial treatment is non-inferior to standard treatment in patients with CAC =0.
AIMS Primary aim 1: Cardiovascular benefit In patients identified with high cardiovascular risk as indicated by a CAC score ≥100, the investigators aim to compare the effect of intensified multifactorial treatment versus standard treatment.
Primary aim 2: Cardiovascular safety In patients identified with low cardiovascular risk as indicated by a CAC score of zero, the investigators aim to compare the effect of less intensive multifactorial treatment versus standard treatment.
Secondary aim 1: Patient-reported outcomes the investigators aim to compare patient-reported outcomes in the CAC-based treatment group and the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The participants are masked for screening results if they are randomized to "standard treatment", but all participants will obtain information on which arm they are randomized.
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Rates of a composite cardiovascular endpoint
时间窗: Event-driven, expected mean follow-up of 5 years
Cardiovascular death, non-fatal myocardial infarction, hospitalization for heart failure, and non-fatal stroke
次要结局
- Patient reported outcomes 2(Change from baseline to End of Study (Event-driven, expected mean follow-up of 5 years))
- Cost-effectiveness(Event-driven, expected mean follow-up of 5 years)
- Rates of all-cause mortality and individual components of the primary outcome(Event-driven, expected mean follow-up of 5 years)
- Patient reported outcomes 3(Change from baseline to End of Study (Event-driven, expected mean follow-up of 5 years))
- Patient reported outcomes 1(Change from baseline to End of Study (Event-driven, expected mean follow-up of 5 years))
研究者
Per Løgstrup Poulsen
Professor
Aarhus University Hospital