Clinical trial NCT04837638: Diet Quality and Coronary Artery Calcification in Adults With Heterozygous Familial Hypercholesterolemia
Official title: Diet Quality and Coronary Artery Calcification in Adults With Heterozygous Familial Hypercholesterolemia
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hypercholesterolemia, Familial
Calcification; Heart
Diet Habit
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Centre de Recheche du Centre Hospitalier Université Laval
name: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
First posted: 2021-04-08
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult men and women with genetically-defined HeFH

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

- Genetically-defined heterozygous familial hypercholesterolemia

Exclusion criteria:

* Homozygous FH
* Personal history of cardiovascular disease
* Personal history of cancer

Primary outcomes:
measure: Relationship between diet quality and coronary artery calcification (CAC)
timeFrame: Diet questionnaire completion and CAC measurement will be completed with a 3 weeks period.
Secondary outcomes:
measure: Relationship between diet quality and LDL-cholesterol.
timeFrame: Diet questionnaire completion and CVD risk factor measurement will be completed with a 3 weeks period.
measure: Relationship between diet quality and Lipoprotein (a).
timeFrame: Diet questionnaire completion and CVD risk factor measurement will be completed with a 3 weeks period.
measure: Relationship between diet quality and intuitive eating.
timeFrame: Diet questionnaire completion and psychological aspects of eating measurement will be completed with a 3 weeks period.
measure: Relationship between diet quality and physical activity
timeFrame: Diet questionnaire completion and lifestyle habit measurement will be completed with a 3 weeks period.
measure: Relationship between diet quality and sleep.
timeFrame: Diet questionnaire completion and lifestyle habit measurement will be completed with a 3 weeks period.
measure: Relationship between diet quality and substance use.
timeFrame: Diet questionnaire completion and lifestyle habit measurement will be completed with a 3 weeks period.
measure: Relationship between diet quality and alcohol consumption.
timeFrame: Diet questionnaire completion and lifestyle habit measurement will be completed with a 3 weeks period.
measure: Relationship between diet quality and medication adherence.
timeFrame: Diet questionnaire completion and lifestyle habit measurement will be completed with a 3 weeks period.
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Institute of nutrition and functional foods, Laval University
Study officials:
affiliation: Laval University
name: Jean-Philippe Drouin-Chartier
role: STUDY_DIRECTOR
affiliation: Laval University
name: Jean-Philippe Drouin-Chartier
role: PRINCIPAL_INVESTIGATOR
References: