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Study to Evaluate Subclinical Atherosclerosis (an Early Sign of Heart Disease) in Healthy Adult Immigrant Asian Indians

Primary Purpose

Healthy

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Flow Mediated Doppler (FMD)
Nitroglycerin 0.4 mg sublingual
Sponsored by
Northwell Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Healthy focused on measuring Healthy Asian Indians and Caucasians

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Asian Indians and Caucasians between the ages of 20 and 65 living in the boroughs of New York City and the Long Island area.

Subjects must provide a record of blood results completed within the past year to determine eligibility (hematology and chemistry results).

Exclusion Criteria:

  • Subjects with major underlying medical problems, including diabetes, hypertension, coronary artery disease (CAD), hyperlipidemia, systolic blood pressure below 90 mm Hg and liver or kidney disease will be excluded.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Assessment of subclinical atherosclerosis in healthy adult immigrant Asian Indians using flow mediated endothelial dysfunction method
    To evaluate subclinical atherosclerosis (an early sign of heart disease) which may be associated with abnormalities like diabetes mellitus, hypertension (high blood pressure), high cholesterol and heart problems.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 9, 2010
    Last Updated
    June 10, 2013
    Sponsor
    Northwell Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01104597
    Brief Title
    Study to Evaluate Subclinical Atherosclerosis (an Early Sign of Heart Disease) in Healthy Adult Immigrant Asian Indians
    Official Title
    Assessment of Subclinical Atherosclerosis in Healthy Adult Immigrant Asian Indians Using Flow Mediated Endothelial Dysfunction Method
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2013
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No subjects were enrolled into the study
    Study Start Date
    April 2010 (undefined)
    Primary Completion Date
    December 2012 (Actual)
    Study Completion Date
    December 2012 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Previous research has shown that Asian Indians are at relatively high risk for developing diabetes, heart problems and high blood pressure. The purpose of this study is to evaluate subclinical atherosclerosis (an early sign of heart disease) which may be associated with abnormalities like diabetes mellitus, hypertension (high blood pressure), high cholesterol and heart problems. Endothelium is the inner lining of your blood vessels. Endothelial dysfunction is found more in people with diabetes. In addition, high body mass index (BMI) is a strong risk factor for developing metabolic abnormalities like diabetes mellitus. This research study may provide information as to how useful endothelial dysfunction will be to detect people at risk of metabolic abnormalities and heart disease at an early stage. Two groups of subjects will be enrolled. Caucasians and Asian Indians There will be a total of 100 subjects participating in this study. Approximately 50 Caucasians and 50 Asian Indians will be enrolled. Caucasians will serve as the control group for this study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Healthy
    Keywords
    Healthy Asian Indians and Caucasians

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    Flow Mediated Doppler (FMD)
    Intervention Description
    Non-invasive assessment of flow-mediated dilation (FMD) will be performed using brachial artery ultrasound.
    Intervention Type
    Drug
    Intervention Name(s)
    Nitroglycerin 0.4 mg sublingual
    Intervention Description
    Nitroglycerin 0.4 mg (a small tablet that dissolves under the tongue) will be given to dilate the arteries. Images of the arm will be recorded via non-invasive flow-mediated doppler for 5 minutes to assess for endothelium dysfunction. as outlined above.
    Primary Outcome Measure Information:
    Title
    Assessment of subclinical atherosclerosis in healthy adult immigrant Asian Indians using flow mediated endothelial dysfunction method
    Description
    To evaluate subclinical atherosclerosis (an early sign of heart disease) which may be associated with abnormalities like diabetes mellitus, hypertension (high blood pressure), high cholesterol and heart problems.
    Time Frame
    April 2010 to April 2012

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Asian Indians and Caucasians between the ages of 20 and 65 living in the boroughs of New York City and the Long Island area. Subjects must provide a record of blood results completed within the past year to determine eligibility (hematology and chemistry results). Exclusion Criteria: Subjects with major underlying medical problems, including diabetes, hypertension, coronary artery disease (CAD), hyperlipidemia, systolic blood pressure below 90 mm Hg and liver or kidney disease will be excluded.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rajiv Jauhar, MD
    Organizational Affiliation
    Northwell Health
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Study to Evaluate Subclinical Atherosclerosis (an Early Sign of Heart Disease) in Healthy Adult Immigrant Asian Indians

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