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

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.

Conditions

• Health Behavior

Interventions

OTHER

SomaSignal Test Results

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.

Sponsors & Collaborators

• SomaLogic, Inc.

  collaborator INDUSTRY

• Intermountain Health Care, Inc.

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-08-12

Primary Completion

2022-09-01

Completion

2022-09-01

Countries

• United States

Study Locations