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临床试验/NCT04462159
NCT04462159进行中(未招募)不适用

Young Patients With Coronary Heart Disease Trial- Assessment of Risk Factors and the Impact of a Risk Reduction Program

Northwell Health1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年5月27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
60
试验地点
1
主要终点
Change in CV Risk Factor - Blood pressure

研究概览

简要总结

The purpose of our project is to better understand the characteristics of the young patients with coronary artery disease presenting for cardiac catheterization at our institution and to put forth a program to optimize their risk factors with a focus on gender differences. We will assess traditional and non-traditional risk factors, as well as genetics and environment. These characteristics will be compared by gender to determine unique factors related to women that could subsequently be targeted. The program will begin with universal education about the process of atherosclerosis, risk factors contributing to the disease and specific risk factor goals for each patient for the 6 month program. The patients will then be part of a bimonthly 6 month cardiovascular risk reduction program that will offer both a nutritional program with teaching kitchen component, and exercise instruction lead by an exercise physiologist. Psychological support will be provided to address stress that impairs quality of life, depression or anxiety to fully optimize the lifestyle component. These sessions will be done virtually in order to comply with social distancing until in person sessions can resume.

The investigational endpoints of this program will include a variety of cardiovascular disease (CVD) risk factors, biomarkers, lifestyle behaviors, quality of life and guideline-based medical regimen. At the end of this phase, we aim to both better understand differences in risk factors and the interventions with the biggest impact in terms of risk factor optimization in men vs. women.

详细描述

After enrollment, participants will meet with researchers where baseline character-istics will be obtained including biometrics such as weight, height, blood pressure, abdominal circumference, etc., as well as a questionnaire that will include validat-ed screening tools for the screening for depression, anxiety, and stress, which are considered non-traditional risk factors for heart disease. The questionnaire will also include other aspects of the participant's lifestyle that could help better understand their risk for heart disease. This questionnaire will be available to be filled out on paper, via email which will be linked with REDCap, and in a tablet provided by our team with the data also being uploaded directly to REDCap.

Blood will also be collected by venipuncture (approximately 12milliliters, 6-8mL for standard of care labs, and 3-4mL for research labs) to assess inflammatory markers, lipids and glucose levels. If based on this initial screening, participants are thought to be at high risk for genetic disease, which likely predisposed them to develop heart disease, they will be offered genetic testing as part of their routine clinical care outside of this research, and an additional consent form will then be provided. We are planning to only recommend genetic testing as per clinical care in those for whom it is recommended by clinical guidelines. When a patient is deemed eligible from a clinical standpoint, they will be referred to our cardio ge-nomics team and be consented as per their clinical protocols and samples, either saliva or blood acquired by venipuncture (about 5ml), will be obtained. Source of sample will be determined by cardio genomics team and this will also fall under their standard of care. If the patient is being enrolled in the outpatient setting and has lab work within the past month, assuming no changes have been made to lipid lowering therapies during that time, we will only need to draw 3-4mL for research labs and possibly one additional tube for Lipoprotein A, as it is not commonly in-cluded in basic lab work.

During their initial consultation while in the hospital, their individual risk would be assessed and the patient will receive counseling on how to further improve said risk. These goals will be reinforced and measures to ensure those goals are met will be implemented when the patient comes to clinic within 2 weeks from their cardiac catheterization. During that visit, they will also be educated on the process of heart disease. Frequency of follow up in clinic will be determined on an individual basis based on individual risk factors, however, all patients are expected to be seen for a minimum of 3 times during those 6 months.

Soon after seeing us for that initial visit in clinic, the group risk reduction program will begin and will last for 6 months with 2 sessions per month (every other week), out of which participants will be required to attend at least 6 for maximum benefit. The sessions will include an exercise and nutrition program.

The nutrition program will be given by a Registered Dietitian Nutritionist and it will consist of a 60min session that will include about 10-15min education, 30min for a cooking demonstration where participants will be able to participate in the process of making heart healthy foods, and 10-15min for questions and answers. Food al-lergies will be reviewed prior to initiation of each session.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with atherosclerotic cardiovascular disease

排除标准

  • Age 60 years or older
  • Physical limitation that will prevent them from being part of the exercise part of the study
  • Given that all the sessions will be given in English, participants not fluent in English will be excluded

结局指标

主要结局

Change in CV Risk Factor - Blood pressure

时间窗: 6 months

Will assess changes pre and post intervention in blood pressure (mmHg)

Change in CV Risk Factor - Physical activity/inactivity

时间窗: 6 months

Will assess changes pre and post intervention in physical activity which will be done through a questionnaire where participants will report the frequency and intensity of exercise

Change in Quality of Life Score

时间窗: 6 months

Surveys of Quality of Life and emotional well-being will be given at baseline and again at the end of the program

Change in Cardiovascular (CV) Risk Factor - Cholesterol levels

时间窗: 6 months

Will assess changes pre and post intervention in Low Density Lipoprotein Cholesterol level (measured in mg/dL)

Change in CV Risk Factor - Glucometabolic state (A1C)

时间窗: 6 months

Will assess changes pre and post intervention in glycemic control measured by the hemoglobin A1C (%)

Change in CV Risk Factor - Smoking Status

时间窗: 6 months

Will assess changes pre and post intervention in smoking status (including quantity of cigarettes)

Change in CV Risk Factors - Diet

时间窗: 6 months

Will assess changes pre and post intervention in diet which will be done via a food intake questionnaire

Change in CV Risk Factor - Overweight/Obesity

时间窗: 6 months

Will assess changes in weight by weighing patients on initial visit and again at follow-up. This value will be used in combination with patient's height to evaluate changes in body mass index.

Change in CV Risk Factors - TMAO levels

时间窗: 6 months

Will assess changes pre and post intervention in trimethylamine N-oxide (TMAO) levels (microM)

Change in CV Risk Factors - hs-CRP levels

时间窗: 6 months

Will assess changes pre and post intervention in high sensitive C-reactive protein (hs-CRP) measured in mg/L

次要结局

  • Number of Cardiovascular events(5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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