The Young Heart Study

NCT04462159 | Active Not Recruiting

• 1 other identifier: 20-0073
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atherosclerotic Cardiovascular Disease; Coronary Artery Disease

Keywords

cardiovascular disease; coronary artery disease; myocardial infarction; risk factors; gender disparities; novel biomarkers; lifestyle behaviors

Outcome Measures

Primary Outcomes (10)

• 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

• Change in CV Risk Factor - Blood pressure

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

  6 months

• 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

• Change in CV Risk Factor - Smoking Status

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

  6 months

• 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

• 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

• 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

• Change in CV Risk Factors - TMAO levels

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

  6 months

• 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

• 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 Outcomes (1)

• Number of Cardiovascular events

  5 years

Study Arms (1)

Risk Reduction Program

EXPERIMENTAL

All participants will receive 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.

Behavioral: Risk Reduction Program

Interventions

Risk Reduction Program BEHAVIORAL

Education, exercise, teaching kitchen and nutrition, and psychological support

Risk Reduction Program

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient with atherosclerotic cardiovascular disease

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Lenox Hill Hospital

New York, New York, 10075, United States

Location

MeSH Terms

Conditions

Atherosclerosis; Coronary Artery Disease; Cardiovascular Diseases; Myocardial Infarction

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Eugenia Gianos, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: July 8, 2020
• Study Start: May 27, 2020
• Primary Completion: March 28, 2022
• Study Completion (Estimated): May 27, 2026
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)