2022-500143-21-01招募中4 期
Screening and intervention for subclinical coronary artery disease in patients with type 2 diabetes: THE STENO INTEN-CT STUDY
Aarhus University Hospital, Odense University Hospital10 个研究点 分布在 1 个国家目标入组 7,300 人开始时间: 2022年7月8日最近更新:
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
- 10
- 主要终点
- Rates of a composite cardiovascular endpoint (cardiovascular death, non-fatal myocardial infarction, hospitalization for heart failure, non-fatal stroke and revascularization of peripheral artery disease).
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •New or former diagnosis of T2DM 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 (cardiovascular death, non-fatal myocardial infarction, hospitalization for heart failure, non-fatal stroke and revascularization of peripheral artery disease).
Rates of a composite cardiovascular endpoint (cardiovascular death, non-fatal myocardial infarction, hospitalization for heart failure, non-fatal stroke and revascularization of peripheral artery disease).
次要结局
- Separate cardiovascular endpoints, all-cause mortality, and renal failure.
- Patient reported outcomes (EQ-5D questionnaire)
- Quality adjusted life years (QALY) using data from the EQ-5D questionnaire and Danish preference weights of the normal population. Register-based rates of procedural codes encompassing tests for atherosclerosis/ischemia of the heart, brain or peripheral circulation and register-based rates of prescription of drugs used in CVD prophylaxis (glucose-lowering drugs, antihypertensive drugs, lipid-lowering drugs and antithrombotic drugs).
研究者
Per Løgstrup Poulsen
Scientific
Aarhus University Hospital
研究点 (10)
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