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SomaSignal Tests for Cardiovascular Disease Risk Management (SomaSignal Trial)
N/A
Recruiting
Research Sponsored by Intermountain Health Care, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female 40 - 80 years of age
Be older than 18 years old
Must not have
Presence of Systemic Lupus Erythematosus
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 months
Awards & highlights
Summary
This trial uses the SomaSignal Test to analyze blood samples and provide health information. It targets patients to see if this test can help guide medical decisions. The test works by examining proteins in the blood to give doctors useful health insights.
Who is the study for?
This trial is for men and women aged 40-80 who are at a higher risk of heart problems, can give informed consent, agree to blood tests, and share their health records. They must be patients at Intermountain Medical Center and able to attend follow-up visits. Pregnant individuals or those with certain conditions like Systemic Lupus Erythematosus or recent participation in other trials cannot join.
What is being tested?
The study is testing the impact of knowing one's SomaSignal Test results on managing heart disease risk. Initially, 12 people will get their results without randomization. Then, 200 more will be randomly assigned (2:1 ratio) to either learn about their test outcomes or not until after six months.
What are the potential side effects?
Since this trial involves only diagnostic tests rather than medications or invasive procedures, typical side effects associated with drugs are not expected. However, minor risks may include discomfort from blood draws.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 40 and 80 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with Systemic Lupus Erythematosus.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Porportion of participants that undergo a change in their treatment plan after receipt of the SomaSignal test.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InformedExperimental Treatment1 Intervention
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.
Group II: UninformedActive Control1 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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for health behaviors often involve personalized medicine approaches, such as the SomaSignal Test, which analyzes blood samples to provide specific medical insights and guide treatment decisions. This method helps in tailoring interventions to the individual's unique biological profile, thereby enhancing the effectiveness of the treatment.
Additionally, behavioral treatments like exercise and mindfulness work by improving physical and mental health through physiological and psychological mechanisms, such as reducing stress and enhancing mood. Pharmacotherapy, on the other hand, targets specific biochemical pathways to manage symptoms and improve overall health.
These treatments are crucial for health behavior patients as they offer targeted, effective strategies to manage and improve their conditions, leading to better health outcomes.
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Who is running the clinical trial?
Intermountain Health Care, Inc.Lead Sponsor
139 Previous Clinical Trials
1,963,760 Total Patients Enrolled
SomaLogic, Inc.Industry Sponsor
6 Previous Clinical Trials
1,138 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 40 and 80 years old.I have been diagnosed with Systemic Lupus Erythematosus.You are unable to communicate effectively.I am willing and able to follow the study's schedule for visits and tests.I am willing and able to have my blood drawn for tests.The Principal Investigator and/or Co-Principal Investigators believe that you have a medical condition that could put you at risk or affect the accuracy of the study results.
Research Study Groups:
This trial has the following groups:- Group 1: Informed
- Group 2: Uninformed
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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