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
Public ClinicalTrials.gov record NCT04836117. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 randomized. These participants will undergo visits and blood draw collection at 3 months. They will be informed of their SomaSignal Test results at baseline and 3 months. Recommendations for any medical management changes will be made based on an understanding of those results. Randomized Study The succeeding 200 participants will be randomized using permuted mixed block randomization, in a 2:1 ratio, i.e., 2 participants to Group 1 (informed of their test results) and 1 participant to Group 2 (uninformed of their test results). At enrollment, and for 6 months thereafter, clinical information will be obtained from each participant's medical records, and/or directly from the participant during procedures, treatments, study-specific visits, and/or follow-up visits. Data collected for the study will have data linkage at SomaLogic, Inc., where data analysis will be done. At baseline and 6-months (+30 days) post-enrollment, patients will undergo a patient visit and blood collection. Blood will be collected as a stand-alone sample collection, or when other ordered lab work is done, or from access lines inserted during a usual or specialized care. Samples will be sent to the Intermountain Central laboratory for clinical testing. A sample will also be processed and shipped to SomaLogic, Inc. for analysis at baseline and 6 months. For the informed arm, the SomaSignal Test reports will be provided at the time they are available (2 to 4 weeks after the blood draw). Any recommended changes in medical management will be recorded in the case report forms and will be verified by the Principal Investigator. For the uninformed arm, the SomaSignal Test results will not be provided to the study team until after the 6-month post-test visit. Adjustments, if any, would be made to the participant's management at that time.
Study identification
- NCT ID
- NCT04836117
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 12 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 11, 2021
- Primary completion
- Aug 31, 2022
- Completion
- Aug 31, 2022
- Last update posted
- Apr 13, 2026
2021 – 2022
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Intermountain Medical Center | Salt Lake City | Utah | 84107 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04836117, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 13, 2026 · Synced Sep 2, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04836117 live on ClinicalTrials.gov.