HealthyNCT01104597
Study to Evaluate Subclinical Atherosclerosis (an Early Sign of Heart Disease) in Healthy Adult Immigrant Asian Indians
A study testing Flow Mediated Doppler (FMD) and Nitroglycerin 0.4 mg sublingual in people with Healthy, run by Northwell Health.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Flow Mediated Doppler (FMD) and Nitroglycerin 0.4 mg sublingual
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
Official title: Assessment of Subclinical Atherosclerosis in Healthy Adult Immigrant Asian Indians Using Flow Mediated Endothelial Dysfunction Method
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.
Read more
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
- Being tested
- Flow Mediated Doppler (FMD), Nitroglycerin 0.4 mg sublingual
- Keywords
- Healthy Asian Indians and Caucasians
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow Mediated Doppler (FMD)Procedure or surgery
Non-invasive assessment of flow-mediated dilation (FMD) will be performed using brachial artery ultrasound.
Nitroglycerin 0.4 mg sublingualDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: April 2010 to April 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: No subjects were enrolled into the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rajiv Jauhar, Northwell Health
- Investigators
- Rajiv Jauhar, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01104597
- Sponsor's protocol ID
- 09-272
- Status last verified
- Jun 2013
- First submitted
- 9 Apr 2010
- Last updated
- 12 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Subclinical Atherosclerosis in Healthy Adult Immigrant Asian Indians Using Flow Mediated Endothelial Dysfunction Method
- ClinicalTrials.gov ID
- NCT01104597
- Acronym / sponsor ID
- 09-272
- Conditions
- Healthy
- Keywords
- Healthy Asian Indians and Caucasians
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No subjects were enrolled into the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 15 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flow Mediated Doppler (FMD)Non-invasive assessment of flow-mediated dilation (FMD) will be performed using brachial artery ultrasound. | Procedure or surgery | – |
| Nitroglycerin 0.4 mg sublingualNitroglycerin 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. | Drug | – |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajiv Jauhar, MD principal investigator
Northwell Health
Questions about this trial
What is this clinical trial studying?
A study testing Flow Mediated Doppler (FMD) and Nitroglycerin 0.4 mg sublingual in people with Healthy, run by Northwell Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of subclinical atherosclerosis in healthy adult immigrant Asian Indians using flow mediated endothelial dysfunction method (time frame: April 2010 to April 2012). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2013.