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The Young Heart Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04462159
Recruitment Status : Recruiting
First Posted : July 8, 2020
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Eugenia Gianos, Northwell Health

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.


Condition or disease Intervention/treatment Phase
Atherosclerotic Cardiovascular Disease Coronary Artery Disease Behavioral: Risk Reduction Program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Young Patients With Coronary Heart Disease Trial- Assessment of Risk Factors and the Impact of a Risk Reduction Program
Actual Study Start Date : May 27, 2020
Estimated Primary Completion Date : May 27, 2021
Estimated Study Completion Date : May 27, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Risk Reduction Program
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
Education, exercise, teaching kitchen and nutrition, and psychological support




Primary Outcome Measures :
  1. Change in CV Risk Factor - Cholesterol levels [ Time Frame: 6 months ]
    Will assess changes pre and post intervention in Low Density Lipoprotein Cholesterol level (measured in mg/dL)

  2. Change in CV Risk Factor - Blood pressure [ Time Frame: 6 months ]
    Will assess changes pre and post intervention in blood pressure (mmHg)

  3. Change in CV Risk Factor - Glucometabolic state (A1C) [ Time Frame: 6 months ]
    Will assess changes pre and post intervention in glycemic control measured by the hemoglobin A1C (%)

  4. Change in CV Risk Factor - Smoking Status [ Time Frame: 6 months ]
    Will assess changes pre and post intervention in smoking status (including quantity of cigarettes)

  5. Change in CV Risk Factor - Physical activity/inactivity [ Time Frame: 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

  6. Change in CV Risk Factor - Overweight/Obesity [ Time Frame: 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.

  7. Change in CV Risk Factors - Diet [ Time Frame: 6 months ]
    Will assess changes pre and post intervention in diet which will be done via a food intake questionnaire

  8. Change in CV Risk Factors - TMAO levels [ Time Frame: 6 months ]
    Will assess changes pre and post intervention in trimethylamine N-oxide (TMAO) levels (microM)

  9. Change in CV Risk Factors - hs-CRP levels [ Time Frame: 6 months ]
    Will assess changes pre and post intervention in high sensitive C-reactive protein measured in mg/L

  10. Change in Quality of Life Score [ Time Frame: 6 months ]
    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 :
  1. Number of Cardiovascular events [ Time Frame: 5 years ]
    Cardiovascular events assessed by a yearly phone call to the patient for up to 5 yrs



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04462159


Contacts
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Contact: Eugenia Gianos, MD 2124346160 egianos@northwell.edu

Locations
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United States, New York
Lenox Hill Hospital Recruiting
New York, New York, United States, 10075
Contact: Eugenia Gianos, MD    212-434-2000    egianos@northwell.edu   
Sponsors and Collaborators
Northwell Health
Investigators
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Principal Investigator: Eugenia Gianos, MD Northwell Health
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Responsible Party: Eugenia Gianos, Director- Cardiovascular Prevention, Associate Professor, Northwell Health
ClinicalTrials.gov Identifier: NCT04462159    
Other Study ID Numbers: 001
First Posted: July 8, 2020    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Atherosclerosis
Cardiovascular Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases