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

Intermountain Health Care, Inc.

Status: Enrolling

Conditions: Health Behavior

Treatments: Other: SomaSignal Test Results

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04836117

1051629

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Informed

Experimental group

Description:

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.

Treatment:

Other: SomaSignal Test Results

Uninformed

No Intervention group

Description:

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.