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Genetic Results Disclosure for Cardiovascular Disease (MVP-ROAR Trial)

N/A

Waitlist Available

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Is identified to have a pathogenic or likely pathogenic variant in the gene(s) of interest in MVP genotype data

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

MVP-ROAR Trial Summary

This trial is designed to study how best to return genetic test results to participants, and to see if this affects their health outcomes or quality of life.

Who is the study for?

This trial is for living participants enrolled in the Million Veteran Program who have been identified with a pathogenic or likely pathogenic variant in specific genes of interest. It's not open to those who are incarcerated, pregnant, or have previously had genetic testing for the condition being studied.Check my eligibility

What is being tested?

The study aims to create a process for returning medically actionable genetic results to MVP participants and assess how this information affects their medical management, health outcomes, and quality of life.See study design

What are the potential side effects?

Since this trial involves result disclosure rather than medication or procedures, traditional physical side effects are not expected. However, receiving genetic information can have emotional or psychological impacts.

MVP-ROAR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My genetic test shows a mutation linked to my condition.

MVP-ROAR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

LDL-C change

Secondary outcome measures

LDL-C target

Pharmacotherapy

Other outcome measures

Cascade testing

Healthcare costs

Lifestyle behaviors

+2 more

MVP-ROAR Trial Design

2Treatment groups

Experimental Treatment

Group I: Immediate ResultsExperimental Treatment1 Intervention

Participants in the Immediate Results arm will receive their genetic testing results from a genetic counselor at baseline following randomization.

Group II: Delayed ResultsExperimental Treatment1 Intervention

Participants in the Delayed Results arm will receive their genetic testing results from a genetic counselor 6 months after randomization.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,175 Total Patients Enrolled

Jason L Vassy, MD MPHStudy ChairVA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

2 Previous Clinical Trials

5,408 Total Patients Enrolled

Media Library

Result disclosure Clinical Trial Eligibility Overview. Trial Name: NCT04178122 — N/A

Cardiovascular Disease Research Study Groups: Immediate Results, Delayed Results

Cardiovascular Disease Clinical Trial 2023: Result disclosure Highlights & Side Effects. Trial Name: NCT04178122 — N/A

Result disclosure 2023 Treatment Timeline for Medical Study. Trial Name: NCT04178122 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available spots for participants in this experiment?

"Based on the information present in clinicaltrials.gov, this trial is no longer seeking recruits. It was first posted on December 30th 2019 and last updated on March 8th 2022; however, there are still approximately 427 other trials actively recruiting patients currently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Million Veteran Program Return of Actionable Results

2019. "Million Veteran Program Return of Actionable Results". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04178122.