SomaSignal Tests for Cardiovascular Disease Risk Management

(SomaSignal Trial)

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. ^{1 2 3 4 5}

How is the SomaSignal test unique in managing cardiovascular disease risk?

The SomaSignal test is unique because it uses novel risk markers to provide a more accurate assessment of cardiovascular disease risk, potentially reducing unnecessary treatments and costs by better identifying patients who truly need intervention. ^{3 4 5 6 7}

Research Team

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

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

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 Overview 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.

Participant Groups

Group I: Informed Experimental Treatment 1 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: Uninformed Active Control 1 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.

Who Is Running the Clinical Trial?

Intermountain Health Care, Inc.

Lead Sponsor

Trials

142

Recruited

1,965,000+

Brent James

Intermountain Health Care, Inc.

Chief Medical Officer since 2010

MD from University of Utah

Rob Allen

Intermountain Health Care, Inc.

Chief Executive Officer since 2022

Bachelor's degree in Business Administration

SomaLogic, Inc.

Industry Sponsor

Trials

7

Recruited

1,300+

Findings from Research

The Framingham Risk Score, while commonly used to assess 10-year risk for coronary heart disease (CHD), does not effectively identify many individuals who will develop CHD, highlighting the need for improved risk assessment tools.

Alternative methods such as coronary artery calcium scoring, C-reactive protein measurement, and evaluating heart rate recovery and exercise tolerance during stress tests may enhance risk stratification for patients at intermediate risk for CHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary prevention for patients with intermediate Framingham risk scores. Thompson, JB., Rivera, JJ., Blumenthal, RS., et al.[2019]

The CAROSS trial will involve 530 regular smokers aged 40-70 to determine if screening for carotid plaques can increase smoking cessation rates and improve control of cardiovascular risk factors over a 1-year period.

This study is unique as it will be the first to evaluate the effectiveness of carotid plaque screening in motivating smokers to quit and manage their cardiovascular health, providing insights into the potential benefits of awareness of subclinical cardiovascular disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Rodondi, N., Bovet, P., Hayoz, D., et al.[2017]

The SCORE index significantly overestimated cardiovascular mortality, predicting rates three times higher than what was actually observed in the population aged 40 to 75 years in Castilla y León.

The study found low sensitivity and predictive values for the SCORE, especially in women and individuals under 65, indicating that the current risk assessment models need to be updated to improve their accuracy in predicting cardiovascular outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Validation of the SCORE index and SCORE for old people in the Castilla y Léon cardiovascular disease risk cohort]. Vega Alonso, AT., Ordax Díez, A., Lozano Alonso, JE., et al.[2020]

The Systemic COronary Risk Evaluation (SCORE) model, developed from data covering approximately 3 million person-years, effectively estimates the risk of fatal cardiovascular disease (CVD) events over a 10-year period, helping clinicians tailor preventative strategies based on total cardiovascular risk.

The SCORE model is being tested in the POWER study, which aims to include around 60,000 patients, to evaluate its effectiveness as a tool for reducing cardiovascular risk in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The SCORE model in the POWER study: an attempt to focus the limited resources for prevention on patients with greatest need. De Backer, G.[2007]

In a study of 720 adults in Poland, a high carotid-femoral pulse wave velocity (CFPWV) was strongly associated with an increased risk of cardiovascular disease (CVD), with an odds ratio of 2.29 for those with a SCORE risk of 5% or higher.

The study established that a CFPWV cut-off value of 11.7 m/s effectively differentiates between low and high CVD risk, demonstrating 58.6% sensitivity and 71.3% specificity, making it a useful measure for assessing cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between carotid-femoral pulse wave velocity and overall cardiovascular risk score assessed by the SCORE system in urban Polish population. Podolec, M., Siniarski, A., Pająk, A., et al.[2019]

The Coronary Artery Calcium Score (CACS) is a valuable tool for improving cardiovascular risk assessment, as it can identify patients who may be at risk for atherosclerosis that traditional models like the Framingham Risk Score and SCORE might miss, potentially reducing unnecessary treatments.

A CACS of 0 can indicate a low risk, allowing for the avoidance of unnecessary interventions, while a CACS of 100 or higher suggests a need for statin treatment, highlighting the importance of CACS in guiding clinical decisions regarding cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subclinical cardiovascular disease and utility of coronary artery calcium score. Saydam, CD.[2023]

Emerging tests from atherosclerosis imaging and laboratory assessments may enhance cardiovascular risk assessment beyond traditional methods, potentially leading to better patient outcomes.

The article reviews statistical methods to evaluate the clinical value of these new tests, providing a foundation for future guidelines on cardiovascular risk prediction by the Swiss Society of Cardiology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement of cardiovascular risk prediction: time to review current knowledge, debates, and fundamentals on how to assess test characteristics. Romanens, M., Ackermann, F., Spence, JD., et al.[2015]

References

1. United States pubmed.ncbi.nlm.nih.gov

Primary prevention for patients with intermediate Framingham risk scores. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

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]

3. Spain pubmed.ncbi.nlm.nih.gov

[Validation of the SCORE index and SCORE for old people in the Castilla y Léon cardiovascular disease risk cohort]. [2020]

4. England pubmed.ncbi.nlm.nih.gov

The SCORE model in the POWER study: an attempt to focus the limited resources for prevention on patients with greatest need. [2007]

5. Poland pubmed.ncbi.nlm.nih.gov

Association between carotid-femoral pulse wave velocity and overall cardiovascular risk score assessed by the SCORE system in urban Polish population. [2019]

6. Ireland pubmed.ncbi.nlm.nih.gov

Subclinical cardiovascular disease and utility of coronary artery calcium score. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Improvement of cardiovascular risk prediction: time to review current knowledge, debates, and fundamentals on how to assess test characteristics. [2015]