Prospective Electronic Polygenic Risk Study (PEPRS1)

November 3, 2022 updated by: Ali Torkamani, Scripps Translational Science Institute

Prospective Electronic Polygenic Risk Study (PEPRS) - First Phase

This study will investigate the role of polygenic risk scores (PRS) in preventive health.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

This study will investigate the role of polygenic risk scores (PRS) in preventive health. Specifically, the purpose of this study is to determine whether knowledge of the degree of coronary artery disease (CAD) genetic risk, as measured and conveyed by a PRS, influences patient and physician decision-making during short-term (6 month) and long-term (2 year) follow-up. The initial findings of this study will be used to plan an expanded second phase study with the purpose of prospectively validating that these decision-making changes lead to improvements in clinical outcomes.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A confidential data request will be submitted to screen the Scripps Health EHR system for individuals meeting study inclusion criteria and having seen a participating study physician in the past two years.

Description

Inclusion Criteria:

  • 45 ≥ Age < 65
  • ASCVD Risk Score > 7.5% as defined by the standard pooled cohort equation
  • Access to and ability to use a smartphone

Exclusion Criteria:

  • Prior diagnosis of coronary disease as defined by prior myocardial infarction (STEMI or NSTEMI), or revascularization (stent or coronary artery bypass grafting)
  • Cerebrovascular disease with history of ischemic stroke, TIA, carotid endarterectomy, carotid artery stenting
  • Peripheral arterial disease with history of claudication, revascularization (stents or bypass)
  • Current and active high-intensity statin prescription (rosuvastatin 20 mg, rosuvastatin 40 mg, atorvastatin 40 mg and atorvastatin 80 mg)
  • Anti-PCSK9 therapy
  • Lipid apheresis therapy
  • Currently enrolled in a clinical trial for lipid lowering therapy
  • Known statin intolerance to 2 or more statins in the past

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Subjects receiving care from Scripps Health physicians in Cardiology and Primary Care
A confidential data request will be submitted to screen the Scripps Health EHR system for individuals meeting study inclusion criteria and having seen a participating study physician in the past two years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Statin or other lipid lowering therapy initiation or intensification by EHR entry
Time Frame: 6 months post enrollment
New or intensified prescriptions for statins or other LDL lowering therapy. Binary outcome measured at 6-months post-enrollment by survey-based self-report and EHR analysis - encoded as 0 if no new or intensified prescription relative to medication status at baseline, and 1 if a new or intensified prescription is entered in the EHR relative to medication status at baseline. A prescription for statins or other LDL lowering therapy is considered new if an EHR entry for a statin, PCSK9i, or ezitimibe is present at follow-up and no equivalent EHR entry exists for up to 1-year prior to enrollment. A statin prescription is considered intensified if an active statin prescription is present in the EHR at enrollment and an active statin prescription of a higher intensity tiers (high-, moderate-, and low-intensity) as described in the 2013 ACC/AHA Guidelines on the Treatment of Blood Cholesterol is present at follow-up.
6 months post enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Statin or other lipid lowering therapy persistence by EHR entry
Time Frame: 2 years post enrollment
Statin or other lipid lowering therapy prescription renewal. Binary outcome measured at 2-years post-enrollment by EHR analysis. Statin persistence is defined as prescription renewal within 60 days of the end of the duration of an index statin prescription made after study enrollment
2 years post enrollment
Statin or other lipid lowering therapy adherence by EHR entry
Time Frame: 2 years post enrollment
Statin or other lipid lowering therapy prescription possession. Binary outcome measured at 2-years post-enrollment by EHR entry. Statin adherence is defined as prescription coverage of no less than 80% of the days between the index statin prescription and the end of the 2-year follow-up period
2 years post enrollment
Adequate LDL-C lowering - comparison of baseline and follow-up measures by lab test
Time Frame: 6 months and 2 years post enrollment
Adequate LDL-C lowering. Adequate LDL-C lowering is defined as 30% or more reduction from baseline study measured LDL-C
6 months and 2 years post enrollment
Lifestyle changes by survey
Time Frame: 6 months post enrollment
Adoption of Healthy Lifestyle. Binary outcomes derived from baseline and 6-months post-enrollment by survey-based self-report.
6 months post enrollment
Physician Utility by survey
Time Frame: 6 months and 1 year
Physician confidence, perceived utility, and actions attributable to genomic testing.
6 months and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scripps Translational Science Institute

Collaborators

Illumina, Inc.
Quest Diagnostics-Nichols Insitute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

November 1, 2023

Study Completion (Anticipated)

November 1, 2023

Study Registration Dates

First Submitted

September 24, 2021

First Submitted That Met QC Criteria

October 5, 2021

First Posted (Actual)

October 8, 2021

Study Record Updates

Last Update Posted (Actual)

November 7, 2022

Last Update Submitted That Met QC Criteria

November 3, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-21-7762

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Research records with patient identification will be kept for 6 years after study completion. The collected data and related de-identified health information may be kept indefinitely. Record retention will comply with the specific requirements of the Scripps IRB (i.e., Scripps Research must keep HIPAA form for at least 6 years after study completion). The results of this research will be presented at meetings or in publication. However, research participants' identities will not be disclosed in those presentations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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