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临床试验/EUCTR2019-001912-50-DK
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:
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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

发起方
Department of Cardiology, Aarhus University Hospital, Denmark

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