PACTR202407499235154尚未招募4 期
Cardiflo: Effectiveness of Cardiflo in the screening of carotid stenosis in patients with clinical symptoms of cardiovascular disease at a tertiary hospital in Cape Town: a screening randomised controlled trial
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 1,200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •1.Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
- •2.Male or female, age =18 years at the time of signing informed consent.
- •3.LDL = 190 mg/dl •ASCVD >10 if LDL =70 mg/dL (as per ACC/AHA guidelines) triglycerides >500 mg/dl
- •4.ASCVD risk score <7.5% with LDL < 190 mg/dl OR •ASCVD risk score 7.5-10% with LDL < 160 mg/dl OR •ASCVD risk score 10-15% with LDL <130 mg/dl
- •5.History of clinical ASCVD (heart attack, stroke) as per by 2013 ACC/AHA Cholesterol Guidelines
- •6.At least one of the below conditions (a-d):
- •a) Coronary heart disease defined as at least one of the following:
- •I.Prior myocardial infarction
- •II.Prior coronary revascularisation procedure
- •III.=50% stenosis in coronary artery documented by cardiac catheterisation or CT
- •IV.coronary angiography
- •V.Coronary heart disease with ischaemia documented by stress test with any
- •VI.imaging modality
- •b) Cerebrovascular disease defined as at least one of the following:
- •I.Prior stroke
- •II.Prior carotid artery revascularisation procedure
- •III.=50% stenosis in carotid artery documented by X-ray angiography, MR
- •IV.angiography, CT angiography or Doppler ultrasound
- •c) Symptomatic peripheral artery disease (PAD) defined as at least one of the following:
- •I.Intermittent claudication with an Ankle-brachial index (ABI) < 0.85 at rest
- •II.Intermittent claudication with a =50% stenosis in peripheral artery (excluding carotid) documented by X-ray angiography, MR angiography, CT angiography or Doppler ultrasound
- •III.Prior peripheral artery (excluding carotid) revascularization procedure
- •IV.Lower extremity amputation at or above ankle due to atherosclerotic disease
- •V.(Excluding e.g., trauma or osteomyelitis)
- •d) Chronic kidney disease defined as: eGFR < 60 mL/min/1.73 m2
排除标准
- •1.Pregnancy, breastfeeding, or refusal to use contraception (for women of reproductive potential).
- •2.Knowledge or suspicion of pregnancy
- •3.Vasoactive medication (e.g., nitro) during the 12 hours prior to the exam
研究者
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