Cardiovascular Risk FactorNCT03599531
Utility of the SomaLogic Cardiovascular Disease (CVD) Secondary Risk Panel for Cardiovascular Risk
An observational study of Cardiovascular Risk Factor and Cardiovascular Diseases, run by SomaLogic, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cardiovascular Risk Factor, Cardiovascular Diseases
- How many people
- 244 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2017to 10 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be 40 years or older with stable Coronary Heart Disease (CHD)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Medical subject headings
- Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start13 Jun 2017
- Primary completion10 Oct 2020
- Study completion10 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- SomaLogic, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen M Williams, MD, PhD, Principal investigator, SomaLogic, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599531
- Sponsor's protocol ID
- CLI1002F011
- Status last verified
- Mar 2021
- First submitted
- 25 May 2018
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03599531
- Acronym / sponsor ID
- CLI1002F011
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- SomaLogic, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Jun 2017 (actual)
- Primary completion
- 10 Oct 2020 (actual)
- Study completion
- 10 Oct 2020 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be 40 years or older with stable Coronary Heart Disease (CHD)
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Decrease in SomaLogic CVD Secondary Risk Score from baseline to follow-up.
Time frame: 12 months
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).
4 secondary outcomes
Motivation for adherence to medication assessed by a self-reported questionnaire.
Time frame: 12 months
Motivation for a healthy diet assessed by a self-reported questionnaire.
Time frame: 12 months
Motivation for exercise assessed by a self-reported questionnaire.
Time frame: 12 months
Motivation for decreased alcohol use assessed by a self-reported questionnaire.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen M Williams, MD, PhD principal investigator
SomaLogic, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Risk Factor and Cardiovascular Diseases, run by SomaLogic, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in SomaLogic CVD Secondary Risk Score from baseline to follow-up. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021; AzTrials last refreshed its copy on 7 Nov 2026.