Status:
RECRUITING
Evaluating the Impact of SomaSignal Tests on Medical Management and Change in Risk in Patients at Higher Risk of Cardiovascular Disease: A Feasibility and an Adaptive Implementation Study
Lead Sponsor:
Intermountain Health Care, Inc.
Collaborating Sponsors:
SomaLogic, Inc.
Conditions:
Health Behavior
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
Feasibility Study Informed consent will be obtained using an IRB-approved form. The first 12 consenting patients will be placed in the planned assessment group for feasibility and will not be randomiz...
Eligibility Criteria
Inclusion
- Male or female 40 - 80 years of age
- Receiving care at Intermountain Medical Center
- At higher than typical risk for cardiovascular events, as assessed by the Principal Investigator or his/her delegate (further defined in the protocol)
- Currently not pregnant
- Ability to understand and sign a written informed consent form which must be obtained prior to initiation of any study procedures
- Willing and able to comply with any virtual or in-person follow-up visits, tests, and schedule of evaluations
- Willing and able to undergo a blood draw for SomaSignal Tests
- Willing and able to provide access to their electronic health records
Exclusion
- Presence of Systemic Lupus Erythematosus
- Inability to communicate appropriately
- Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study
- Other conditions that in the opinion of the Principal Investigator and/or Co-Principal Investigators may increase risk to the participants and/or compromise the quality of the clinical trial
- The Principal Investigator and/or Co-Principal Investigator determine(s) that the participant is not eligible for participation in this research study.
Key Trial Info
Start Date :
August 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 12 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04836117
Start Date
August 12 2021
End Date
August 12 2025
Last Update
May 24 2024
Active Locations (1)
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1
Intermountain Medical Center
Salt Lake City, Utah, United States, 84107