NCT00862056已完成不适用
Prospective Detection of Subclinical Atherosclerosis in Asymptomatic Individuals With High Likelihood of Coronary Artery Disease With a Novel, Low-Radiation Volumetric Computed Tomography Approach
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- The primary endpoint of the study is identifying the prevalence of coronary artery disease (CAD) in an asymptomatic population of patients without prior history of, but with high likelihood of CAD.
研究概览
简要总结
This study will evaluate the use of cardiac CT in identifying atherosclerosis plaque in patients who have not been diagnosed with atherosclerosis and who have no symptoms of the disease but who are at risk of developing atherosclerosis based on traditional risk factors such as diabetes or a family history of coronary artery disease.
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
- 35 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males between ages 35-90 or females between ages 40-90
- •No known coronary artery disease
- •no prior coronary disease by cardiac catheterization (no more than 40% in any major epicardial vessel)
- •no prior myocardial infarction
- •no prior ST-elevation myocardial infarction (1 mm ST-elevation in 2 contiguous leads)
- •no prior non-ST-elevation myocardial infarction (CK-MB > 2x ULN or elevated troponin that is indicative of myocardial necrosis based on local institutional cutpoints)
- •no prior coronary revascularization procedure
- •Aymptomatic
- •no chest pain, shortness of breath, angina or angina-equivalent that is assumed to be related to myocardial ischemia
- •Presence of a high-risk feature (at least one of the following four will quality)
- •High FRS ≥20% (http://hp2010.nhlbihin.net/atpiii/calculator.asp)
- •Diabetes Mellitus
- •Premature CAD in a first-degree relative
- •High Risk Lipid Profile (must meet one of the following laboratory criteria)
- •LDL > 250 mg/dL
- •HDL < 20 mg/dL
- •Triglycerides > 1000 mg/dL
- •LP(a) > 80 mg/dL
- •Provide written informed consent and Authorization for Use/Disclosure of PHI
排除标准
- •Known genetic form of hypercholesterolemia based on clinical criteria (e.g. familial hypercholesterolemia, etc.)
- •Creatinine 1.5 mg/dL or greater
- •Irregular rhythm precluding cardiac CT examination
- •Uncontrolled hypertension (SBP>210 mmHg or DBP>140 mmHg on treatment)
- •Known moderate or severe allergy to iodine-based contrast agents (mild prior reactions that could be treated as an outpatient or that could be prevented by pre-medication in the past do not constitute exclusion)
- •Known Pregnancy
- •Unwilling or unable to consent
- •Presence of any co-morbidity that makes life expectancy less than 24 months
- •Unwilling or unable to complete follow-up
- •Unwilling or unable to provide written informed consent and Authorization for Use/Disclosure of PHI
结局指标
主要结局
The primary endpoint of the study is identifying the prevalence of coronary artery disease (CAD) in an asymptomatic population of patients without prior history of, but with high likelihood of CAD.
时间窗: 6 months, 1 year
次要结局
未报告次要终点
研究者
研究点 (1)
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