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NCT04462159 · ClinicalTrials.gov registry record · NA

The Young Heart Study

A NA study of Coronary Artery Disease and Atherosclerotic Cardiovascular Disease, sponsored by Northwell Health.

Active
Registry status
NA
Development phase
60
Enrollment target
1
Study location

NCT04462159 is a NA study of Coronary Artery Disease and Atherosclerotic Cardiovascular Disease that is active but no longer recruiting, run by Northwell Health. The registered enrollment target is 60 participants, below the 1,287-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04462159, a NA study of Coronary Artery Disease and Atherosclerotic Cardiovascular Disease, is active but no longer recruiting, sponsored by Northwell Health.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
60 participants
Enrollment target
1
Study location

Study 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.

Interventions

  • BEHAVIORAL Risk Reduction Program

Study Locations (1)

New York

  • Lenox Hill Hospital - New York

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2020-05-27
Est. Completion 2026-05-27
Phase NA

Sponsor

Northwell Health

370 total trials

What the Registry Record Tells You About NCT04462159

The ClinicalTrials.gov registry entry for NCT04462159 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,287-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (95% lower). The listed sponsor is Northwell Health, which has 370 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Coronary Artery Disease appearing as the primary indexed condition, and to 1 intervention - of which Risk Reduction Program is the first listed.

NCT04462159 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT04462159 about?

NCT04462159 is a clinical study titled "The Young Heart Study". 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...

What is the current status of trial NCT04462159?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2020-05-27. Estimated completion is 2026-05-27.

What conditions does trial NCT04462159 study?

This clinical trial studies the following conditions: Coronary Artery Disease, Atherosclerotic Cardiovascular Disease.

What interventions are being tested in trial NCT04462159?

The interventions under investigation include: Risk Reduction Program (BEHAVIORAL).

Who is sponsoring clinical trial NCT04462159?

This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04462159 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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