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

NCT03599531 | Completed

• 1 other identifier: CLI1002F011
• Study Type: observational
• Target: 244
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Risk Factor; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Motivation for adherence to medication assessed by a self-reported questionnaire.

  12 months

• Motivation for a healthy diet assessed by a self-reported questionnaire.

  12 months

• Motivation for exercise assessed by a self-reported questionnaire.

  12 months

• Motivation for decreased alcohol use assessed by a self-reported questionnaire.

  12 months

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• SomaLogic, Inc.: lead

Study Sites (1)

Boulder Heart

Boulder, Colorado, 80301, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

EDTA plasma blood

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Stephen M Williams, MD, PhD

  SomaLogic, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: July 26, 2018
• Study Start: June 13, 2017
• Primary Completion: October 10, 2020
• Study Completion: October 10, 2020
• Last Updated: March 17, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)