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临床试验/NCT04837638
NCT04837638进行中(未招募)不适用

Diet Quality and Coronary Artery Calcification in Adults With Heterozygous Familial Hypercholesterolemia

Laval University1 个研究点 分布在 1 个国家目标入组 258 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
258
试验地点
1
主要终点
Relationship between diet quality and coronary artery calcification (CAC)

研究概览

简要总结

The overarching objective is to evaluate the relationship between diet and coronary artery calcification in patients with heterozygous familial hypercholesterolemia (HeFH). We will recruit adults with HeFH. They will have to complete questionnaires on diet, medication and lifestyle. Coronary artery calcification will be measured in each patient using a CT scan. Physiological and biochemical data will be collected.

详细描述

The proposed research will deploy as cross-sectional study including treated adults with genetically-defined HeFH. Once recruited, participants will be asked to complete web-based questionnaires on diet, medication and lifestyle. They will thereafter complete a clinical assessment at the Clinical Investigation Unit of the NUTRISS-INAF Research Centre. Study staff will measure participants' height, weight, and waist circumference. Participants' blood pressure will be measured using an automatic blood pressure monitor (BP Thru, Omron) after sitting quietly for 10 minutes. Three sequential readings will be taken with three minutes between readings. Fasting blood samples (10 mL) will be collected from an antecubital vein. Body composition will be assessed with dual-energy X-ray absorptiometry (DEXA). Finally, participants will be asked to provide the full list of medication they are using, including type, dose and duration of use. Later on the same day, participants will undergo the non-contrast CT scan at the Quebec Heart and Lung Institute. Multidetector CT scans without contrast will be performed using a 256 slices helical scanner (Brilliance iCT, Philips).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Genetically-defined heterozygous familial hypercholesterolemia
  • Exclusion criteria:
  • Homozygous FH
  • Personal history of cardiovascular disease
  • Personal history of cancer

排除标准

  • 未提供

结局指标

主要结局

Relationship between diet quality and coronary artery calcification (CAC)

时间窗: Diet questionnaire completion and CAC measurement will be completed with a 3 weeks period.

Diet quality indices reflecting different dimensions of diet will be used as the main exposure, including the Alternative Mediterranean Diet Index (AMED, 9-45 points), the Alternative Healthy Eating Index (AHEI, 0-100 points), the Dietary Approach to Stop Hypertension index (DASHi, 8-40 points), the healthy plant-based diet index (hPDI, 18-90 points) and the unhealthy plant-based diet index (uPDI, 18-90 points). Higher scores reflect higher diet quality, except for the uPDI which reflect lower diet quality. CAC will be measured using non-constrat CT scan. CAC scores will be quantified with the Agatston scoring method. Higher CAC scores reflect higher CAC.

次要结局

  • Relationship between diet quality and LDL-cholesterol.(Diet questionnaire completion and CVD risk factor measurement will be completed with a 3 weeks period.)
  • Relationship between diet quality and Lipoprotein (a).(Diet questionnaire completion and CVD risk factor measurement will be completed with a 3 weeks period.)
  • Relationship between diet quality and intuitive eating.(Diet questionnaire completion and psychological aspects of eating measurement will be completed with a 3 weeks period.)
  • Relationship between diet quality and physical activity(Diet questionnaire completion and lifestyle habit measurement will be completed with a 3 weeks period.)
  • Relationship between diet quality and sleep.(Diet questionnaire completion and lifestyle habit measurement will be completed with a 3 weeks period.)
  • Relationship between diet quality and substance use.(Diet questionnaire completion and lifestyle habit measurement will be completed with a 3 weeks period.)
  • Relationship between diet quality and alcohol consumption.(Diet questionnaire completion and lifestyle habit measurement will be completed with a 3 weeks period.)
  • Relationship between diet quality and medication adherence.(Diet questionnaire completion and lifestyle habit measurement will be completed with a 3 weeks period.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jean-Philippe Drouin-Chartier

Professor

Laval University

研究点 (1)

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