Clinical trial NCT03599531: Utility of the SomaLogic Cardiovascular Disease (CVD) Secondary Risk Panel for Cardiovascular Risk
Official title: A Pilot Study to Evaluate the Utility of the SomaLogic Cardiovascular Disease (CVD) Secondary Risk Panel as a a Tool to Stratify Cardiovascular Risk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Risk Factor
Cardiovascular Diseases
Lead sponsor: SomaLogic, Inc.
Sponsor class: INDUSTRY
First posted: 2018-07-26
Enrollment: 244
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be 40 years or older with stable Coronary Heart Disease (CHD)

Brief summary: This is a prospective pilot study of participants who have stable coronary heart disease (CHD). Participants undergo risk stratification using the SomaLogic Cardiovascular Disease (CVD) Risk Panel blood test at baseline and again 4-12 months after the initial test. Participant surveys and chart abstractions are conducted at baseline and follow-up to collect feedback about the test report and actions taken. Care teams may consider using the risk information from the SomaLogic panel to address care gaps. Medical treatment decisions and recommendations are confirmed by established clinical methods, including blood pressure monitoring, body mass index (BMI), lipid and c-reactive protein (CRP) measurements, and physician's clinical judgment.

Detailed description: This is a prospective pilot study of participants who have stable coronary heart disease (CHD). Objectives of this study are to understand whether CVD Secondary Risk Panel scores change from baseline to follow-up (4-12 months after baseline) and actions taken, if any, based upon the results. Participants are surveyed to learn what the test results mean to them and assess if the results affect adherence to therapy and lifestyle choices (diet, exercise, alcohol, and tobacco use). In addition, this study will investigate the characteristics of patients that physicians choose to test with the CVD Secondary Risk Panel, and what actions the care team takes because of the results of the test. Medical treatment decisions and recommendations are confirmed by established clinical methods, including blood pressure monitoring, BMI, lipid and CRP measurements, and physician's clinical judgement. Chart abstractions and participants surveys occur at the baseline and follow-up visits, and charts may be abstracted annually for up to 10 years post enrollment.

Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 40
* Stable CHD documented by at least one of the following: history of myocardial infarction \>6 months prior to study enrollment, angiographic evidence of at least 50% stenosis, abnormal CAC score, prior evidence of inducible ischemia by treadmill or nuclear testing, or a history of coronary revascularization
* Ability to provide informed consent

Exclusion Criteria:

* Inability or unwillingness to provide informed consent
* Less than 40 years of age
* History of myocardial infarction in the prior 6 months.
* Treatment for malignancy (other than basal or squamous cell carcinomas of the skin) within the last 2 years
* Pregnancy
* Individuals deemed ineligible by the Investigator

Primary outcomes:
measure: Decrease in SomaLogic CVD Secondary Risk Score from baseline to follow-up.
timeFrame: 12 months
Secondary outcomes:
measure: Motivation for adherence to medication assessed by a self-reported questionnaire.
timeFrame: 12 months
measure: Motivation for a healthy diet assessed by a self-reported questionnaire.
timeFrame: 12 months
measure: Motivation for exercise assessed by a self-reported questionnaire.
timeFrame: 12 months
measure: Motivation for decreased alcohol use assessed by a self-reported questionnaire.
timeFrame: 12 months
Other outcomes:
Locations:
city: Boulder
country: United States
facility: Boulder Heart
state: Colorado
Study officials:
affiliation: SomaLogic, Inc.
name: Stephen M Williams, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: