Study to Evaluate Subclinical Atherosclerosis (an Early Sign of Heart Disease) in Healthy Adult Immigrant Asian Indians
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|ClinicalTrials.gov Identifier: NCT01104597|
Recruitment Status : Withdrawn (No subjects were enrolled into the study)
First Posted : April 15, 2010
Last Update Posted : June 12, 2013
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 or disease||Intervention/treatment||Phase|
|Healthy||Procedure: Flow Mediated Doppler (FMD) Drug: Nitroglycerin 0.4 mg sublingual||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
- 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.
- Assessment of subclinical atherosclerosis in healthy adult immigrant Asian Indians using flow mediated endothelial dysfunction method [ Time Frame: April 2010 to April 2012 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01104597
|Principal Investigator:||Rajiv Jauhar, MD||Northwell Health|