Field Center Scope of Work Hispanic Community Health Study/Study of Latinos (HCHS/SOL) Ancillary Study (AS) on Coronary Artery Calcium and its Association with Protective/Risk Factors and Epigenetic Patterns The proposed Northwestern University subcontract under the project entitled, “Coronary Artery Calcium and its Association with Protective/Risk Factors and Epigenetic Patterns in Diverse US Hispanic/Latino Adults” (Lead institution: University of Illinois at Chicago; Multiple Principal Investigators: Drs. Martha L. Daviglus, Matthew Budoff, Lifang Hou, and Linda Gallo), will be led by Dr. Lifang Hou at the Department of Preventive Medicine at Northwestern University’s Feinberg School of Medicine. Dr. Hou will collaborate with Drs. Daviglus, Budoff, and Gallo as well as with other investigators across study sites to accomplish the aims of this project, i.e., to generate critical new data on the absence of subclinical atherosclerosis (assessed via coronary CT scan) in Hispanic/Latino adults from diverse ethnic backgrounds, and to examine relationships with potentially protective sociocultural factors specific to Hispanic/Latino populations, traditional CVD risk factors, lifestyle factors, and genetic and epigenetic patterns. For this Ancillary Study, Dr. Hou will not recruit any participants (men and women of diverse Hispanic/Latino backgrounds, ages 45 years and older and free of known history of cardiovascular disease at that time) in coordination with the parent HCHS/SOL Visit 3 examinations. Scans will be scheduled at an accelerated rate in year 1 to catch up with Visit 3 recruitment, necessitated by the later start date for this AS (45%, 33%, and 22% of scans will be conducted in years 1-3, respectively). Participants will be contacted by study personnel, screened using a brief eligibility questionnaire, and invited to undergo CT scanning. They will be given the option of having the CT scan performed immediately after their parent clinic visit or on a separate day (within 2-4 weeks). At the visit, clinic personnel will verify eligibility/screening information, describe the study and the benefits/ potential risks of CT scanning, and obtain written informed consent. Participants will be escorted by study personnel to the CT scanning facility near the HCHS/SOL Field Center. Standard and high-resolution non-contrast submillimeter thin-slice ECG-gated CT scans will be conducted using a 64-slice (or higher) CT scanner by trained, certified CT technicians following the standardized protocol specified by this study’s CT Reading Center. Field center personnel will also be involved in quality assurance activities and will be responsible for transmitting the CT scan data to the CT Reading Center (Los Angeles Biomedical Research Institute). Of note, this AS will not assess CVD risk factors or collect blood samples since Visit 3 will include objective assessments of CVD risk factors. Epigenetic assays will be conducted at Northwestern University using stored blood DNA samples from Visits 1 and 2. Existing data for HCHS/SOL from the NHLBI Trans-Omics for Precision Medicine (TOPMed) whole genome sequencing (WGS) project will be used to identify genetic biomarkers and causal effects of epigenetic biomarkers. Thus,no additional tasks will be required of the Field Centers for the epigenetic analyses aim of the study. Scans will be read centrally at the CT Reading Center. Results of non-urgent clinically-relevant CT measures will be sent by field centers to participants (and their physicians if they wish) within 4 weeks. Site PIs/Medical Dire
|Effective start/end date||6/1/21 → 5/31/25|
- University of Illinois at Chicago (18741 AMD1 // 5R01HL152692-02)
- National Heart, Lung, and Blood Institute (18741 AMD1 // 5R01HL152692-02)
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