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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 months
Awards & highlights
SomaSignal Trial Summary
This trial is a feasibility and randomized study to test a new blood test that may help doctors better manage cancer. The first 12 patients will not be randomized, and their results will be used to assess feasibility. The remaining 200 patients will be randomized, with 2/3 of them being informed of their test results and 1/3 not being informed.
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.Check my eligibility
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.See study design
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.
SomaSignal Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 40 and 80 years old.
SomaSignal Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Porportion of participants that undergo a change in their treatment plan after receipt of the SomaSignal test.
SomaSignal 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.
Find a Location
Who is running the clinical trial?
Intermountain Health Care, Inc.Lead Sponsor
137 Previous Clinical Trials
1,962,910 Total Patients Enrolled
SomaLogic, Inc.Industry Sponsor
6 Previous Clinical Trials
1,138 Total Patients Enrolled
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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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are the elderly being sought after for this particular research project?
"The age requirements to enroll in this trial are between 40 and 80 years old."
Answered by AI
To date, how many individuals have signed up for this clinical trial?
"Yes, that is accurate. The clinical trial is recruiting for 200 patients at 1 locations."
Answered by AI
Which type of patient is best-suited for this clinical trial?
"Researchers conducting this study are looking for 200 participants that have unhealthy habits and are between 40-80 years old. To be eligible, potential patients must go to Intermountain Medical Center, be willing to complete follow-up visits virtually or in-person, and have access to their electronic health records. In addition, applicants must be male or female, not pregnant, and be at a higher risk for cardiovascular events."
Answered by AI
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