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Withdrawn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
About this trial
This is an interventional health services research trial for Healthy focused on measuring Healthy Asian Indians and Caucasians
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.
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
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Withdrawn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
We'll reach out to this number within 24 hrs