Clinical trial NCT04836117: 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
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Health Behavior
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
Collaborators: name: SomaLogic, Inc.
First posted: 2021-04-08
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Porportion of participants that undergo a change in their treatment plan after receipt of the SomaSignal test.
timeFrame: Baseline, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Intermountain Medical Center
state: Utah
Study officials:
References:
citation: 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.
citation: Ganz 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.
citation: Williams 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.