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The Young Heart Study

Primary Purpose

Atherosclerotic Cardiovascular Disease, Coronary Artery Disease

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Risk Reduction Program
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Atherosclerotic Cardiovascular Disease

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient with atherosclerotic cardiovascular disease

Exclusion Criteria:

  • Age 55 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

Sites / Locations

  • Lenox Hill Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Risk Reduction Program

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in CV Risk Factor - Cholesterol levels
Will assess changes pre and post intervention in Low Density Lipoprotein Cholesterol level (measured in mg/dL)
Change in CV Risk Factor - Blood pressure
Will assess changes pre and post intervention in blood pressure (mmHg)
Change in CV Risk Factor - Glucometabolic state (A1C)
Will assess changes pre and post intervention in glycemic control measured by the hemoglobin A1C (%)
Change in CV Risk Factor - Smoking Status
Will assess changes pre and post intervention in smoking status (including quantity of cigarettes)
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
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.
Change in CV Risk Factors - Diet
Will assess changes pre and post intervention in diet which will be done via a food intake questionnaire
Change in CV Risk Factors - TMAO levels
Will assess changes pre and post intervention in trimethylamine N-oxide (TMAO) levels (microM)
Change in CV Risk Factors - hs-CRP levels
Will assess changes pre and post intervention in high sensitive C-reactive protein measured in mg/L
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

Secondary Outcome Measures

Number of Cardiovascular events
Cardiovascular events assessed by a yearly phone call to the patient for up to 5 yrs

Full Information

First Posted
February 20, 2020
Last Updated
October 25, 2022
Sponsor
Northwell Health
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1. Study Identification

Unique Protocol Identification Number
NCT04462159
Brief Title
The Young Heart Study
Official Title
Young Patients With Coronary Heart Disease Trial- Assessment of Risk Factors and the Impact of a Risk Reduction Program
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 27, 2020 (Actual)
Primary Completion Date
March 28, 2022 (Actual)
Study Completion Date
May 27, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerotic Cardiovascular Disease, Coronary Artery Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with atherosclerotic cardiovascular disease Exclusion Criteria: Age 55 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugenia Gianos, MD
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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The Young Heart Study

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