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

NCT01104597 | Withdrawn

• 1 other identifier: 09-272
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

Healthy Asian Indians and Caucasians

Outcome Measures

Primary Outcomes (1)

• 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.

  April 2010 to April 2012

Interventions

Flow Mediated Doppler (FMD) PROCEDURE

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

Nitroglycerin 0.4 mg sublingual DRUG

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.

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwell Health: lead

MeSH Terms

Interventions

Nitroglycerin; Administration, Sublingual

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals; Administration, Oral; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Rajiv Jauhar, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Cardiology

Study Record Dates

• First Submitted: April 9, 2010
• First Posted: April 15, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 12, 2013

Record last verified: 2013-06