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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04462159
Other study ID # 20-0073
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 27, 2020
Est. completion date May 27, 2026

Study information

Verified date October 2023
Source Northwell Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Risk Reduction Program
Education, exercise, teaching kitchen and nutrition, and psychological support

Locations

Country Name City State
United States Lenox Hill Hospital New York New York

Sponsors (1)

Lead Sponsor Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Cardiovascular (CV) Risk Factor - Cholesterol levels Will assess changes pre and post intervention in Low Density Lipoprotein Cholesterol level (measured in mg/dL) 6 months
Primary Change in CV Risk Factor - Blood pressure Will assess changes pre and post intervention in blood pressure (mmHg) 6 months
Primary Change in CV Risk Factor - Glucometabolic state (A1C) Will assess changes pre and post intervention in glycemic control measured by the hemoglobin A1C (%) 6 months
Primary Change in CV Risk Factor - Smoking Status Will assess changes pre and post intervention in smoking status (including quantity of cigarettes) 6 months
Primary Change in CV Risk Factor - Physical activity/inactivity 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 6 months
Primary Change in CV Risk Factor - Overweight/Obesity 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. 6 months
Primary Change in CV Risk Factors - Diet Will assess changes pre and post intervention in diet which will be done via a food intake questionnaire 6 months
Primary Change in CV Risk Factors - TMAO levels Will assess changes pre and post intervention in trimethylamine N-oxide (TMAO) levels (microM) 6 months
Primary Change in CV Risk Factors - hs-CRP levels Will assess changes pre and post intervention in high sensitive C-reactive protein (hs-CRP) measured in mg/L 6 months
Primary Change in Quality of Life Score Surveys of Quality of Life and emotional well-being will be given at baseline and again at the end of the program 6 months
Secondary Number of Cardiovascular events Cardiovascular events assessed by a yearly phone call to the patient for up to 5 yrs 5 years
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