Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT01207167
Status:
RECRUITING
Last Update Posted:
2025-03-25
First Post:
2010-09-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mediators of Atherosclerosis in South Asians Living in America
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2314}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2010-09-21', 'studyFirstSubmitQcDate': '2010-09-21', 'lastUpdatePostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Coronary artery calcium prevalence in South Asians', 'timeFrame': 'Baseline'}], 'secondaryOutcomes': [{'measure': 'Carotid intima media thickness', 'timeFrame': 'Baseline'}, {'measure': 'Diabetes Prevalence', 'timeFrame': 'Baseline'}, {'measure': 'Change from baseline Coronary artery calcium prevalence in South Asians at 4 years', 'timeFrame': 'Baseline to Year 4'}, {'measure': 'Incidence of type 2 diabetes after approximately 4 years of follow-up', 'timeFrame': 'Baseline to Year 4'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atherosclerosis', 'Cardiovascular Diseases', 'Heart Diseases', 'Coronary Artery Disease', 'Coronary Disease']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '84 Years', 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* South Asian ancestry defined by having at least 3 grandparents born in one of the following countries: India, Pakistan, Bangladesh, Nepal, or Sri Lanka\n* age between 40 and 84 years.\n\nExclusion Criteria:\n\n* Physician diagnosed heart attack, stroke or transient ischemic attack (TIA), heart failure, or angina (or use of nitroglycerin)\n* Current atrial fibrillation\n* 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)\n* Active treatment for cancer\n* Life expectancy less than 5 years due to serious medical illness\n* Impaired cognitive ability as judged by the reviewer\n* Plans to move out of the study region in next 5 years\n* Weight greater than 300 pounds\n* Living in a nursing home or on a waiting list\n* Unable to speak/read/write English, Hindi, Urdu, or Bangla'}, 'identificationModule': {'nctId': 'NCT01207167', 'acronym': 'MASALA', 'briefTitle': 'Mediators of Atherosclerosis in South Asians Living in America', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Mediators of Atherosclerosis in South Asians Living in America', 'orgStudyIdInfo': {'id': 'MASALA'}, 'secondaryIdInfos': [{'id': 'R01HL093009', 'link': 'https://reporter.nih.gov/quickSearch/R01HL093009', 'type': 'NIH'}, {'id': 'R01MD016071', 'link': 'https://reporter.nih.gov/quickSearch/R01MD016071', 'type': 'NIH'}, {'id': 'R01HL149809', 'link': 'https://reporter.nih.gov/quickSearch/R01HL149809', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Meredith Rathert', 'role': 'CONTACT', 'email': 'meredith.rathert@northwestern.edu'}, {'name': 'Namratha Kandula, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shahmir Ali', 'role': 'CONTACT', 'email': 'sha371@nyu.edu'}, {'name': 'Nadia Islam, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'New York University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Alka Kanaya, MD', 'role': 'CONTACT', 'email': 'alka.kanaya@ucsf.edu'}, {'name': 'Ann Chang', 'role': 'CONTACT', 'email': 'ann.chang@ucsf.edu'}], 'overallOfficials': [{'name': 'Alka Kanaya, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Namratha Kandula, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}, {'name': 'Nadia Islam, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Northwestern University', 'class': 'OTHER'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'National Institute on Minority Health and Health Disparities (NIMHD)', 'class': 'NIH'}, {'name': 'New York University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}