EUCTR2019-001912-50-DK进行中(未招募)1 期
Influence of Intensive Lipid-lowering with statin and ezetimbe prescription on Computed Tomography Derived Fractional Flow Reserve in Patients With Stable Chest Pain: The FLOW-PROMOTE study - FLOWPROMOTE study
Department of Cardiology, Aarhus University Hospital, Denmark0 个研究点目标入组 120 人开始时间: 2019年7月24日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients must meet all of the following criteria:
- •? Age >40 years
- •?Symptoms suggestive of stable CAD
- •? No known CAD
- •? At least one stenosis with =50% lumen reduction determined by coronary CTA
- •? Sinus rhythm
- •? LDL cholesterol >2.0 mM*
- •? FFRCT =0.80 (Figure 2)
- •? Life expectancy >3 years
- •? Signed informed consent
- •? Minimum one stenosis =50% (visually or QCA).
- •*Patients already on lipid lowering medical therapy can be included if meeting all of the above mentioned inclusion criteria.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Patients must meet none of the following criteria:
- •? Unstable angina
- •? Known CAD
- •? Allergy to iodinated contrast media
- •? Poor coronary CTA image quality inadequate for FFRCT calculation (determined by core laboratory)
- •? Significant LM (stenosis >50%) or 3-vessel CAD determined by coronary CTA leading to direct referral to ICA (Figure 2)
- •? Pregnancy
- •? Participation in another clinical trial
- •? Does not wish to participate
- •Coronary computed tomography exclusion criteria:
- •LM- stenosis =50%, 3-VD or high-grade proximal LAD stenosis resulting in direct referral to ICA.
研究者
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