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临床试验/NCT00321542
NCT00321542Unknown不适用

Assessment of the Additive Value of Multislice Computed Tomographic Angiography of the Coronary Arteries in the Prediction of Acute Cardiac Events in Asymptomatic Individuals With Type II Diabetes Mellitus

Carmel Medical Center1 个研究点 分布在 1 个国家目标入组 793 人开始时间: 2006年9月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
793
试验地点
1
主要终点
Death or acute myocardial infarction

研究概览

简要总结

The study aims to examine if non-invasive imaging of the coronary arteries by CT angiography using an intra-venous injection of X-ray contrast medium in asymptomatic patients with adult onset diabetes mellitus can predict the risk of developing coronary heart disease.

详细描述

Patients having diabetes mellitus are at increased risk for the development of coronary heart disease. Available tests do not accurately predict which diabetic patients are at greatest risk of suffering from a coronary event. The recent development of coronary CT angiography allows non-invasive imaging of both coronary narrowing and of disease (atheroma) in the coronary arterial wall at an earlier stage of the disease before the development of coronary arterial narrowing.

In this study we will collect all the readily available patient medical data relating to diabetes and its complications and other coronary artery disease risk factors. In addition patients will be referred for exercise stress testing and for eye examinations. The coronary CT angiogram will be carefully examined for early signs of coronary artery disease. In the event of a finding on the CT scan requiring medical therapy this will be communicated to the patient and his treating physician. In the event of a finding on the stress test or CT scan requiring further medical work-up the patient will be referred to the cardiology clinic.

In general patients will be followed in the regular diabetic clinic and by their family practitioners.

In the event of any acute symptoms over the next few years possibly related to heart disease and requiring emergency room examination patients will be requested to report to the emergency room at the hospital at which the CT study was performed whenever possible.In such an event a repeat CT scan will be performed to examine if any new findings are present. In the event of any new complaints requiring referral to an out of hospital clinic patients will be referred for further assessment to the cardiology clinic and a repeat CT scan may be performed if deemed relevant.

Outcomes of all patients will be examined at 2 years or later using computerized databases. Patients undergoing hospitalization during the follow up period of at least 2-3 years will be contacted by the study staff to obtain further details of the event and hospital findings .

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
55 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type II diabetes mellitus
  • No symptoms of coronary heart disease
  • At least one additional risk factor for coronary artery disease

排除标准

  • Known coronary artery disease
  • Kidney failure if more than mild
  • Allergy to iodinated X-ray contrast media
  • Chronic atrial fibrillation

结局指标

主要结局

Death or acute myocardial infarction

时间窗: 7 years

次要结局

  • Composite of the primary outcome and the onset of new symptoms of coronary artery disease with proven myocardial ischemia (supported by treadmill, nuclear scan or stress echo findings) or the need for a revascularization procedure.(7 years)

研究者

发起方
Carmel Medical Center
申办方类型
Other
责任方
Sponsor

研究点 (1)

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