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

NCT ID: NCT01104597

Last Updated: 2013-06-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2012-12-31

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Interventions

Flow Mediated Doppler (FMD)

Non-invasive assessment of flow-mediated dilation (FMD) will be performed using brachial artery ultrasound.

Intervention Type: PROCEDURE

Nitroglycerin 0.4 mg sublingual

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Rajiv Jauhar

Chief, Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rajiv Jauhar, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Other Identifiers

09-272

Identifier Type: -

Identifier Source: org_study_id