SomaSignal Tests for Cardiovascular Disease Risk Management
(SomaSignal Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Intermountain Health Care, Inc.
Disqualifiers: Systemic lupus erythematosus, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It seems that any changes to your medical management will be based on the results of the SomaSignal Test, but this is not explicitly stated.
What data supports the effectiveness of the SomaSignal Tests for Cardiovascular Disease Risk Management treatment?
The SCORE model, which is used to estimate cardiovascular risk, has been validated in various studies and is widely used in Europe for assessing overall cardiovascular risk. This suggests that similar risk assessment tools, like the SomaSignal Tests, could be effective in identifying individuals at high cardiovascular risk and guiding preventative strategies.12345
How is the SomaSignal test unique in managing cardiovascular disease risk?
Eligibility Criteria
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.Inclusion Criteria
At higher than typical risk for cardiovascular events, as assessed by the Principal Investigator or his/her delegate (further defined in the protocol)
I am between 40 and 80 years old.
Ability to understand and sign a written informed consent form which must be obtained prior to initiation of any study procedures
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Exclusion Criteria
I have been diagnosed with Systemic Lupus Erythematosus.
You are unable to communicate effectively.
Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Feasibility Study
First 12 consenting patients undergo visits and blood draw collection at 3 months. They are informed of their SomaSignal Test results at baseline and 3 months.
3 months
2 visits (in-person)
Randomized Study
200 participants are randomized. Clinical information is obtained at enrollment and for 6 months thereafter. Blood collection and SomaSignal Test analysis at baseline and 6 months.
6 months
2 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment. SomaSignal Test results are discussed with participants.
1 month
1 visit (in-person or virtual)
Treatment Details
Interventions
- SomaSignal Test Results (Diagnostic Test)
Trial OverviewThe 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.
Participant Groups
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 Clinic Near You
Research Locations NearbySelect from list below to view details:
Intermountain Medical CenterSalt Lake City, UT
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Who Is Running the Clinical Trial?
Intermountain Health Care, Inc.Lead Sponsor
SomaLogic, Inc.Industry Sponsor
References
Primary prevention for patients with intermediate Framingham risk scores. [2019]Coronary heart disease (CHD) is the leading cause of mortality in the industrialized world. Proper identification of individuals at risk for CHD is challenging. The Framingham Risk Score, the most widely accepted tool for quantifying 10-year risk, fails to identify a great proportion of future CHD. Because of the health and economic consequences of CHD, there is a need to develop better prognostic tools for primary prevention. Coronary artery calcium scoring, C-reactive protein measurement, and heart rate recovery and exercise tolerance during exercise stress test may be useful tools for better risk stratification of intermediate-risk patients.
The Impact of CAROtid plaque Screening on Smoking (CAROSS) cessation and control of other cardiovascular risk factors: Rationale and design of a randomized controlled trial. [2017]Screening tests for subclinical cardiovascular disease, such as markers of atherosclerosis, are increasingly used in clinical prevention to identify individuals at high cardiovascular risk. Being aware of these test results might also enhance patient motivation to change unhealthy behaviors but the effectiveness of such a screening strategy has been poorly studied.
[Validation of the SCORE index and SCORE for old people in the Castilla y Léon cardiovascular disease risk cohort]. [2020]The Systematic Coronary Risk Evaluation (SCORE) is the most extended index in Europe for overall cardiovascular risk assessment. This study aims to validate the calculated risk with the observed 10-year cardiovascular mortality in a population cohort aged 40 to 75 years.
The SCORE model in the POWER study: an attempt to focus the limited resources for prevention on patients with greatest need. [2007]As the emergence of cardiovascular disease (CVD) is linked to modifiable lifestyle and physiological factors, it is increasingly important to concentrate on preventative strategies. For preventative measures to be beneficial it is necessary to clearly identify patients at risk--given that multiple risk factors often cluster this requires the assessment of total cardiovascular (CV) risk. Total CV risk can be estimated in different ways; in the guidelines on the management of arterial hypertension by a Joint Task Force of the European Society of Hypertension and the European Society of Cardiology a categorical approach was recommended. A model based on results from the US Framingham study has been available for many years. Systemic COronary Risk Evaluation (SCORE) is a recently developed total CV risk assessment model, based on approximately 3 million person-years of observation, which estimates fatal CVD events over a 10-year period, incorporating both coronary heart disease and cerebrovascular disease. The SCORE model aids clinicians in their decision on how to engage in preventative measures and how to adjust the intensity of their preventative efforts in accordance with the total CV risk of the patient. The SCORE model has been incorporated into the Physicians Observational Work on Patient Education According to their Vascular Risk (POWER) study. This study, with an estimated sample size of 60,000 patients, will determine if SCORE can act as a suitable tool to aid the lowering of CV risk.
Association between carotid-femoral pulse wave velocity and overall cardiovascular risk score assessed by the SCORE system in urban Polish population. [2019]The Systemic COronary Risk Estimation (SCORE) system is recommended for the assessment of cardiovascular disease (CVD) death risk in individuals free of CVD.
Subclinical cardiovascular disease and utility of coronary artery calcium score. [2023]ASCVD are the leading causes of mortality and morbidity among Globe. Evaluation of patients' comprehensive and personalized risk provides risk management strategies and preventive interventions to achieve gain for patients. Framingham Risk Score (FRS) and Systemic Coronary Risk Evaluation Score (SCORE) are two well studied risk scoring models, however, can miss some (20-35%) of future cardiovascular events. To obtain more accurate risk assessment recalibrating risk models through utilizing novel risk markers have been studied in last 3 decades and both ESC and AHA recommends assessing Family History, hs-CRP, CACS, ABI, and CIMT. Subclinical Cardiovascular Disease (SCVD) has been conceptually developed for investigating gradually progressing asymptomatic development of atherosclerosis and among these novel risk markers it has been well established by literature that CACS having highest improvement in risk assessment. This review study mainly selectively discussing studies with CACS measurement. A CACS = 0 can down-stratify risk of patients otherwise treated or treatment eligible before test and can reduce unnecessary interventions and cost, whereas CACS ≥ 100 is equivalent to statin treatment threshold of ≥ 7.5% risk level otherwise statin ineligible before test. Since inflammation, insulin resistance, oxidative stress, dyslipidemia and ongoing endothelial damage due to hypertension could lead to CAC, ASCVD linked with comorbidities. Recent cohort studies have shown a CACS 100-300 as a sign of increased cancer risk. Physical activity, dietary factors, cigarette use, alcohol consumption, metabolic health, family history of CHD, aging, exposures of neighborhood environment and non-cardiovascular comorbidities can determine CACs changes.
Improvement of cardiovascular risk prediction: time to review current knowledge, debates, and fundamentals on how to assess test characteristics. [2015]Cardiovascular risk assessment might be improved with the addition of emerging, new tests derived from atherosclerosis imaging, laboratory tests or functional tests. This article reviews relative risk, odds ratios, receiver-operating curves, posttest risk calculations based on likelihood ratios, the net reclassification improvement and integrated discrimination. This serves to determine whether a new test has an added clinical value on top of conventional risk testing and how this can be verified statistically. Two clinically meaningful examples serve to illustrate novel approaches. This work serves as a review and basic work for the development of new guidelines on cardiovascular risk prediction, taking into account emerging tests, to be proposed by members of the 'Taskforce on Vascular Risk Prediction' under the auspices of the Working Group 'Swiss Atherosclerosis' of the Swiss Society of Cardiology in the future.