Evaluating the impact of SomaSignal tests on cardiovascular disease management
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 (SomaSignal Study)
This study is testing if SomaSignal tests can help doctors manage the care of patients at higher risk for heart disease by comparing how treatment changes when patients know their test results versus when they don’t.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Intermountain Health Care, Inc. Academic / other |
| Locations | 1 site (Salt Lake City, Utah) |
| Trial ID | NCT04836117 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the feasibility and effectiveness of SomaSignal tests in managing patients at higher risk for cardiovascular disease. Initially, 12 participants will undergo assessments without randomization, followed by a randomized phase involving 200 participants split into two groups: one informed of their test results and the other not. Participants will have their clinical information collected over six months, including blood draws and follow-up visits, to evaluate changes in medical management based on test results.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 40 to 80 who are at higher risk for cardiovascular events and receiving care at Intermountain Medical Center.
Not a fit: Patients with systemic lupus erythematosus or those unable to communicate appropriately may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiovascular disease management and risk reduction for patients.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using biomarker tests for managing cardiovascular risk.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female 40 - 80 years of age 2. Receiving care at Intermountain Medical Center 3. At higher than typical risk for cardiovascular events, as assessed by the Principal Investigator or his/her delegate (further defined in the protocol) 4. Currently not pregnant 5. Ability to understand and sign a written informed consent form which must be obtained prior to initiation of any study procedures 6. Willing and able to comply with any virtual or in-person follow-up visits, tests, and schedule of evaluations 7. Willing and able to undergo a blood draw for SomaSignal Tests 8. Willing and able to provide access to their electronic health records Exclusion Criteria: 1. Presence of Systemic Lupus Erythematosus 2. Inability to communicate appropriately 3. Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study 4. 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 5. The Principal Investigator and/or Co-Principal Investigator determine(s) that the participant is not eligible for participation in this research study.
Where this trial is running
Salt Lake City, Utah
- Intermountain Medical Center — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Darija Rujaic Ward
- Email: Darija.RujaicWard@imail.org
- Phone: 8015074701
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.