A Randomized Trial of Integrating Whole Genome Sequencing and Digital Twins Into the Management of Hypercholesterolemia in Emiratis
Status: Recruiting
Location: See location...
Intervention Type: Genetic
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This pilot study investigates integrating whole genome sequencing and digital twin technology for managing hypercholesterolemia in Abu Dhabi clinics. It aims to establish protocols for larger future studies and incorporate genomic insights into routine medical care.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:
• Patients with 2 or more LDL-C levels greater than 190 mg/dL or 5.0 mmol/L in the past 12 months
• Undiagnosed patients meeting Possible, Probable or Definitive FH criteria according to Dutch Lipid Clinic Network (DLCN) criteria (Eur Heart J. 2011 Jul;32(14):1769-818. doi: 10.1093/eurheartj/ehr158. Epub 2011 Jun 28.)
• Patients who have not been on anti-lipidemic medication in the past 3 months
• Ages 18-55
• Emirati national
• All patients must be fluent in English or Arabic
Locations
Other Locations
United Arab Emirates
Abu Dhabi Health Research Center
RECRUITING
Abu Dhabi
Contact Information
Primary
Alina Naeem, MBBS
alnaeem@seha.ae
+97124102534
Backup
Mhy-Lanie Adduru, MD
mhy-lanie@predictivcare.com
+14088311991
Time Frame
Start Date: 2024-07-29
Estimated Completion Date: 2026-07-15
Participants
Target number of participants: 40
Treatments
Experimental: WGS + Digital Twin Group
20 participants who are randomized to have whole-genome sequencing performed on their sample and given access to Predictiv™ Digital Twin. These participants will meet with a genetic counselor for results disclosure and training to access the Predictiv™ Digital Twin platform.
No_intervention: Standard of Care Group
20 participants who are randomized to not have whole-genome sequencing performed on their sample. These participants will have standard-of-care familial hypercholesterolemia (FH) evaluation using medical history and family history only. They will not receive genetic results or Predictiv™ Digital Twin results as part of this study.
Related Therapeutic Areas
Sponsors
Collaborators: Predictiv Care, Inc.
Leads: Abu Dhabi Health Services Company