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

Study Overview
=================
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 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.

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)

Conditions
-----------------
Health Behavior

Intervention / Treatment
-----------------
* Other: SomaSignal Test Results


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Informed<br>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. | Other: SomaSignal Test Results<br>* 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.<br>|
| No Intervention: Uninformed<br>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 the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 6 months |