Utility of the SomaLogic Cardiovascular Disease (CVD) Secondary Risk Panel for Cardiovascular Risk

A Pilot Study to Evaluate the Utility of the SomaLogic Cardiovascular Disease (CVD) Secondary Risk Panel as a a Tool to Stratify Cardiovascular Risk

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Cardiovascular Risk Factor

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.

• Study Type: Observational
• Enrollment (Actual): 244

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Boulder, Colorado, United States, 80301
      • Boulder Heart

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants will be 40 years or older with stable Coronary Heart Disease (CHD)

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in SomaLogic CVD Secondary Risk Score from baseline to follow-up.	Percent of participants whose CVD risk score decreased from baseline to follow-up. This is assessed on a numeric scale of 1 (lower risk) to 5 (higher risk).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motivation for adherence to medication assessed by a self-reported questionnaire.	Impact of the CVD Secondary Risk Score on patient adherence to therapy. Assessed by percent of patients whose motivation to adhere increased on a 5-point scale from baseline to follow-up.	12 months
Motivation for a healthy diet assessed by a self-reported questionnaire.	Impact of the CVD Secondary Risk Score on diet. Assessed by percent of patients whose motivation for a healthy diet increased on a 5-point scale from baseline to follow-up.	12 months
Motivation for exercise assessed by a self-reported questionnaire.	Impact of the CVD Secondary Risk Score on exercise. Assessed by percent of patients whose motivation to exercise increased on a 5-point scale from baseline to follow-up.	12 months
Motivation for decreased alcohol use assessed by a self-reported questionnaire.	Impact of the CVD Secondary Risk Score on alcohol use. Assessed by percent of patients whose alcohol use decreased on a 5-point scale from baseline to follow-up.	12 months

Collaborators and Investigators

• Sponsor: SomaLogic, Inc.
• Investigators: Principal Investigator: Stephen M Williams, MD, PhD, SomaLogic, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 13, 2017
• Primary Completion (ACTUAL): October 10, 2020
• Study Completion (ACTUAL): October 10, 2020

Study Registration Dates

• First Submitted: May 25, 2018
• First Submitted That Met QC Criteria: July 23, 2018
• First Posted (ACTUAL): July 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 15, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: CLI1002F011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No