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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by North Shore Long Island Jewish Health System.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01104597
First received: April 9, 2010
Last updated: March 1, 2011
Last verified: March 2011
History of Changes
  Purpose

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.


Condition Intervention
Healthy
 Procedure: Flow Mediated Doppler (FMD)
Drug: Nitroglycerin 0.4 mg sublingual

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Assessment of Subclinical Atherosclerosis in Healthy Adult Immigrant Asian Indians Using Flow Mediated Endothelial Dysfunction Method

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • Assessment of subclinical atherosclerosis in healthy adult immigrant Asian Indians using flow mediated endothelial dysfunction method [ Time Frame: April 2010 to April 2012 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: April 2010
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Flow Mediated Doppler (FMD)
    Non-invasive assessment of flow-mediated dilation (FMD) will be performed using brachial artery ultrasound.
    Drug: 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.
  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01104597

Contacts
Contact: Rajiv Jauhar, MD 718-470-7340 rjauhar@lij.edu
Contact: Marie Cox, DNP, RN, NP-C 718-470-4257 mcox@nshs.edu

Locations
United States, New York
Long Island Jewish Medical Center Recruiting
New Hyde Park, New York, United States, 11040
Principal Investigator: Rajiv Jauhar, MD            
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Investigators
Principal Investigator: Rajiv Jauhar, MD North Shore LIJ Health System
  More Information

No publications provided

Responsible Party: Rajiv Jauhar, MD, North Shore Health System - Long Island Jewish Medical Center
ClinicalTrials.gov Identifier: NCT01104597     History of Changes
Other Study ID Numbers: 09-272
Study First Received: April 9, 2010
Last Updated: March 1, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by North Shore Long Island Jewish Health System:
Healthy Asian Indians and Caucasians

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
 Nitroglycerin
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013