AtherosclerosisMASALANCT01207167
Mediators of Atherosclerosis in South Asians Living in America
An observational study of Atherosclerosis and Cardiovascular Diseases, run by University of California, San Francisco at 3 sites in United States.
Trial summary
South Asian (Indian, Pakistani, Bangladeshi, Nepali, and Sri Lankan) individuals have high rates of cardiovascular disease that is not explained by traditional cardiovascular risk factors. Read more about this study
- Who is it for?
- Ages 40 to 84 years
- Conditions the study is for
- Atherosclerosis, Cardiovascular Diseases, Heart Diseases
- How many people
- 2,314 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2010to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: South Asians (individuals from India, Pakistan, Nepal, Bangladesh, and Sri Lanka) adults between the ages of 40 and 84 years without cardiovascular disease living in the San Francisco Bay Area, Chicago Area, or New York City Area.
Who may be able to join
- South Asian ancestry defined by having at least 3 grandparents born in one of the following countries: India, Pakistan, Bangladesh, Nepal, or Sri Lanka
- age between 40 and 84 years.
Who cannot join
- Physician diagnosed heart attack, stroke or transient ischemic attack (TIA), heart failure, or angina (or use of nitroglycerin)
- Current atrial fibrillation
- Past history of cardiovascular procedures (coronary artery bypass graft (CABG) Surgery, angioplasty, valve replacement, pacemaker or defibrillator implantation, or any surgery on the heart or arteries)
- Active treatment for cancer
- Life expectancy less than 5 years due to serious medical illness
- Impaired cognitive ability as judged by the reviewer
Show all 10Show fewer
- Plans to move out of the study region in next 5 years
- Weight greater than 300 pounds
- Living in a nursing home or on a waiting list
- Unable to speak/read/write English, Hindi, Urdu, or Bangla
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Northwestern University
Chicago, Illinois, 60611
New York University
New York, New York
University of California, San Francisco
San Francisco, California, 94115
About this study
South Asian (Indian, Pakistani, Bangladeshi, Nepali, and Sri Lankan) individuals have high rates of cardiovascular disease that is not explained by traditional cardiovascular risk factors. Though South Asians represent over one-quarter of the world's population, there are no longitudinal studies in this high-risk ethnic group. The investigators aim to establish a longitudinal study of South Asians at three United States centers to identify risk factors linked to subclinical atherosclerosis and incident cardiovascular disease. The purpose of this study is to understand the causes of heart disease and stroke in South Asians and compare these causes to those in other United States ethnic groups.
- Conditions
- Atherosclerosis, Cardiovascular Diseases, Heart Diseases, Coronary Artery Disease, Coronary Disease
- Medical subject headings
- Atherosclerosis, Cardiovascular Diseases, Heart Diseases, Coronary Artery Disease, Coronary Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary artery calcium prevalence in South Asians
Measured: Baseline
Secondary outcomes (4)
Carotid intima media thickness
Measured: Baseline
Diabetes Prevalence
Measured: Baseline
Change from baseline Coronary artery calcium prevalence in South Asians at 4 years
Measured: Baseline to Year 4
Incidence of type 2 diabetes after approximately 4 years of follow-up
Measured: Baseline to Year 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionMar 2013
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,314 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, National Heart, Lung, and Blood Institute (NHLBI), National Institute on Minority Health and Health Disparities (NIMHD), New York University
- Responsible party
- Sponsor
- Investigators
- Alka Kanaya, MD, Principal investigator, University of California, San FranciscoNamratha Kandula, MD, Principal investigator, Northwestern UniversityNadia Islam, PhD, Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01207167
- Sponsor's protocol ID
- MASALA
- Other IDs
- R01HL093009, R01MD016071, R01HL149809
- Acronym
- MASALA
- Status last verified
- Jan 2026
- First submitted
- 21 Sep 2010
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mediators of Atherosclerosis in South Asians Living in America
- ClinicalTrials.gov ID
- NCT01207167
- Acronym / sponsor ID
- MASALA / MASALA
- Conditions
- Atherosclerosis, Cardiovascular Diseases, Heart Diseases, Coronary Artery Disease, Coronary Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,314 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Northwestern University, National Heart, Lung, and Blood Institute (NHLBI), National Institute on Minority Health and Health Disparities (NIMHD), New York University
- Study start
- Sep 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Apr 2027 (estimated)
- First posted
- 22 Sep 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.
South Asian (Indian, Pakistani, Bangladeshi, Nepali, and Sri Lankan) individuals have high rates of cardiovascular disease that is not explained by traditional cardiovascular risk factors. Though South Asians represent over one-quarter of the world's population, there are no longitudinal studies in this high-risk ethnic group. The investigators aim to establish a longitudinal study of South Asians at three United States centers to identify risk factors linked to subclinical atherosclerosis and incident cardiovascular disease. The purpose of this study is to understand the causes of heart disease and stroke in South Asians and compare these causes to those in other United States ethnic groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- South Asians (individuals from India, Pakistan, Nepal, Bangladesh, and Sri Lanka) adults between the ages of 40 and 84 years without cardiovascular disease living in the San Francisco Bay Area, Chicago Area, or New York City Area.
Key inclusion criteria (2 listed)
- South Asian ancestry defined by having at least 3 grandparents born in one of the following countries: India, Pakistan, Bangladesh, Nepal, or Sri Lanka
- age between 40 and 84 years.
Key exclusion criteria (10 listed)
- Physician diagnosed heart attack, stroke or transient ischemic attack (TIA), heart failure, or angina (or use of nitroglycerin)
- Current atrial fibrillation
- Past history of cardiovascular procedures (coronary artery bypass graft (CABG) Surgery, angioplasty, valve replacement, pacemaker or defibrillator implantation, or any surgery on the heart or arteries)
- Active treatment for cancer
- Life expectancy less than 5 years due to serious medical illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Coronary artery calcium prevalence in South Asians
Time frame: Baseline
4 secondary outcomes
Carotid intima media thickness
Time frame: Baseline
Diabetes Prevalence
Time frame: Baseline
Change from baseline Coronary artery calcium prevalence in South Asians at 4 years
Time frame: Baseline to Year 4
Incidence of type 2 diabetes after approximately 4 years of follow-up
Time frame: Baseline to Year 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Alka Kanaya, MD principal investigator
University of California, San Francisco
Namratha Kandula, MD principal investigator
Northwestern University
Nadia Islam, PhD principal investigator
New York University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis and Cardiovascular Diseases, run by University of California, San Francisco at 3 sites in United States.
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 10 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: under way, not looking for participants, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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?
Coronary artery calcium prevalence in South Asians (time frame: Baseline). 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 26 Jan 2026.