Health BehaviorSomaSignalNCT04836117
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
A study testing SomaSignal Test Results in people with Health Behavior, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial 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 randomized. These participants will undergo visits and blood draw collection at 3 months. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Health Behavior
- What is being tested?
- SomaSignal Test Results
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2021to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Intermountain Medical Center
Salt Lake City, Utah, 84107
About this study
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)
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.
Read more
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.
- Conditions
- Health Behavior
- Being tested
- SomaSignal Test Results
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomaSignal Test ResultsOther
SomaLogic, Inc. translates patterns from 5000 protein measurements made in thousands of participants in clinical trials into validated models (SomaSignal Tests) that predict important health outcomes or correlate with established health measures. SomaLogic, Inc. has developed these protein-based tests for the detection, subtyping and prognosis of heart disease and related medical, physiological and behavioral conditions. These tests are demonstrated in large retrospective studies to provide information superior to best available alternatives.
| Study group | Role | What they receive |
|---|---|---|
| Informed | Experimental | Blood draw for SomaSignal Test and laboratory assessments at baseline, and 6 months (±30 days); SomaSignal Test results to be sent to investigators as available. Review and discussion of results with the participant from baseline and 6 months within 30 days (2-4 weeks to get SomaSignal results) after blood draw. Initiation of changes in medical management as soon as test results are known and discussed with patient.
Patients will have a blood draw performed at baseline and 6 months for lipid panel, hemoglobin A1C, CBC, and BMP. Receives: Other: SomaSignal Test Results |
| Uninformed | No intervention | Blood draw for SomaSignal Test at baseline and 6 months (+30 days). However, results will not be provided to clinician and participant until study conclusion. Patients contacted within 30 days (2-4 weeks) after baseline and 6-month visits to discuss treatment strategy (nothing, add/ remove medication, etc.) made at visit. Patients will have a blood draw performed at baseline and for lipid panel, hemoglobin A1C, CBC, and BMP SomaSignal Test results to be sent to investigators AFTER study conclusion. Patients will be provided with SomaSignal Test results after the 6 month post-test timepoint. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Porportion of participants that undergo a change in their treatment plan after receipt of the SomaSignal test.
Lifestyle changes are defined as referrals for
- A structured dietary or weight loss program (ie., Intermountain's Weigh to Health)
- Physical therapy for cardiovascular fitness
- Cardiac rehabilitation Medications
- Antianginals
- Antiarrhythmics
- Antilipidemics
- Coagulation modifiers
- Heart failure medications
- Hypertension medications
- Antidiabetic
- Antiplatelets
Patients will receive a point for each change made. Documentation will be made on whether the change was made because of the SomaSignal results, a side-effect or a request by the patient, or a non-SomaSignal test related reason. The total number of changes at baseline and 6-months will be computed for each patient and will be compared between the arms.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start12 Aug 2021
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Why it stopped: 12 patients were enrolled to determine feasibility. It was mutually agreed that there was low feasibility and not to proceed with the larger study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- SomaLogic, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04836117
- Sponsor's protocol ID
- 1051629
- Acronym
- SomaSignal
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2021
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Williams SA, Murthy AC, DeLisle RK, Hyde C, Malarstig A, Ostroff R, Weiss SJ, Segal MR, Ganz P. Improving Assessment of Drug Safety Through Proteomics: Early Detection and Mechanistic Characterization of the Unforeseen Harmful Effects of Torcetrapib. Circulation. 2018 Mar 6;137(10):999-1010. doi: 10.1161/CIRCULATIONAHA.117.028213. Epub 2017 Oct 3.
PubMed 28974520Ganz P, Heidecker B, Hveem K, Jonasson C, Kato S, Segal MR, Sterling DG, Williams SA. Development and Validation of a Protein-Based Risk Score for Cardiovascular Outcomes Among Patients With Stable Coronary Heart Disease. JAMA. 2016 Jun 21;315(23):2532-41. doi: 10.1001/jama.2016.5951.
PubMed 27327800Williams SA, Kivimaki M, Langenberg C, Hingorani AD, Casas JP, Bouchard C, Jonasson C, Sarzynski MA, Shipley MJ, Alexander L, Ash J, Bauer T, Chadwick J, Datta G, DeLisle RK, Hagar Y, Hinterberg M, Ostroff R, Weiss S, Ganz P, Wareham NJ. Plasma protein patterns as comprehensive indicators of health. Nat Med. 2019 Dec;25(12):1851-1857. doi: 10.1038/s41591-019-0665-2. Epub 2019 Dec 2.
PubMed 31792462
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04836117
- Acronym / sponsor ID
- SomaSignal / 1051629
- Conditions
- Health Behavior
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 12 patients were enrolled to determine feasibility. It was mutually agreed that there was low feasibility and not to proceed with the larger study.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- SomaLogic, Inc.
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Informed | Experimental | Other: SomaSignal Test ResultsBlood draw for SomaSignal Test and laboratory assessments at baseline, and 6 months (±30 days); SomaSignal Test results to be sent to investigators as available. Review and discussion of results with the participant from baseline and 6 months within 30 days (2-4 weeks to get SomaSignal results) after blood draw. Initiation of changes in medical management as soon as test results are known and discussed with patient. Patients will have a blood draw performed at baseline and 6 months for lipid panel, hemoglobin A1C, CBC, and BMP. |
| Uninformed | No intervention | –Blood draw for SomaSignal Test at baseline and 6 months (+30 days). However, results will not be provided to clinician and participant until study conclusion. Patients contacted within 30 days (2-4 weeks) after baseline and 6-month visits to discuss treatment strategy (nothing, add/ remove medication, etc.) made at visit. Patients will have a blood draw performed at baseline and for lipid panel, hemoglobin A1C, CBC, and BMP SomaSignal Test results to be sent to investigators AFTER study conclusion. Patients will be provided with SomaSignal Test results after the 6 month post-test timepoint. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SomaSignal Test ResultsSomaLogic, Inc. translates patterns from 5000 protein measurements made in thousands of participants in clinical trials into validated models (SomaSignal Tests) that predict important health outcomes or correlate with established health measures. SomaLogic, Inc. has developed these protein-based tests for the detection, subtyping and prognosis of heart disease and related medical, physiological and behavioral conditions. These tests are demonstrated in large retrospective studies to provide information superior to best available alternatives. | Other | Informed |
Primary outcome
Porportion of participants that undergo a change in their treatment plan after receipt of the SomaSignal test.
Time frame: Baseline, 6 months
Lifestyle changes are defined as referrals for * A structured dietary or weight loss program (ie., Intermountain's Weigh to Health) * Physical therapy for cardiovascular fitness * Cardiac rehabilitation Medications * Antianginals * Antiarrhythmics * Antilipidemics * Coagulation modifiers * Heart failure medications * Hypertension medications * Antidiabetic * Antiplatelets Patients will receive a point for each change made. Documentation will be made on whether the change was made because of the SomaSignal results, a side-effect or a request by the patient, or a non-SomaSignal test related reason. The total number of changes at baseline and 6-months will be computed for each patient and will be compared between the arms.
Results and safety
The study was stopped early (reason given: 12 patients were enrolled to determine feasibility. It was mutually agreed that there was low feasibility and not to proceed with the larger study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Background: PubMed 28974520Williams SA, Murthy AC, DeLisle RK, Hyde C, Malarstig A, Ostroff R, Weiss SJ, Segal MR, Ganz P. Improving Assessment of Drug Safety Through Proteomics: Early Detection and Mechanistic Characterization of the Unforeseen Harmful Effects of Torcetrapib. Circulation. 2018 Mar 6;137(10):999-1010. doi: 10.1161/CIRCULATIONAHA.117.028213. Epub 2017 Oct 3.
- Background: PubMed 27327800Ganz P, Heidecker B, Hveem K, Jonasson C, Kato S, Segal MR, Sterling DG, Williams SA. Development and Validation of a Protein-Based Risk Score for Cardiovascular Outcomes Among Patients With Stable Coronary Heart Disease. JAMA. 2016 Jun 21;315(23):2532-41. doi: 10.1001/jama.2016.5951.
- Background: PubMed 31792462Williams SA, Kivimaki M, Langenberg C, Hingorani AD, Casas JP, Bouchard C, Jonasson C, Sarzynski MA, Shipley MJ, Alexander L, Ash J, Bauer T, Chadwick J, Datta G, DeLisle RK, Hagar Y, Hinterberg M, Ostroff R, Weiss S, Ganz P, Wareham NJ. Plasma protein patterns as comprehensive indicators of health. Nat Med. 2019 Dec;25(12):1851-1857. doi: 10.1038/s41591-019-0665-2. Epub 2019 Dec 2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SomaSignal Test Results in people with Health Behavior, run by Intermountain Health Care, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 12 patients were enrolled to determine feasibility. It was mutually agreed that there was low feasibility and not to proceed with the larger study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Porportion of participants that undergo a change in their treatment plan after receipt of the SomaSignal test. (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04836117, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.