← Back to Search

Direct Contact Genetic Screening for High Cholesterol

N/A

Recruiting

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

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

Must have

Proband must be a KCNQ1 Thr224Met or APOB R3527Q carrier

Proband must be 18 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion: approximately 4 years

Awards & highlights

Study Summary

This trial will test two methods of screening at-risk family members for genetic variants that may increase their risk of disease.

Who is the study for?

This trial is for adults who carry the KCNQ1 Met224Thr or APOB Arg3527Gln genetic variant, which can be linked to conditions like Long QT Syndrome and high cholesterol. Their first-degree relatives are also eligible as part of a family-based screening approach.Check my eligibility

What is being tested?

The study compares two methods of informing family members about their risk for certain genetic conditions: direct contact by the study team versus indirect contact initiated by the patient (proband). It aims to determine which method is more effective and respectful of privacy.See study design

What are the potential side effects?

There are no direct physical side effects from participating in this trial since it involves communication strategies rather than medical treatments. However, there may be mental or psychosocial impacts due to learning about one's genetic risks.

Eligibility Criteria

Inclusion Criteria

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

Select...

I carry the KCNQ1 Thr224Met or APOB R3527Q gene mutation.

Select...

I am 18 years old or older.

Select...

A close family member has the KCNQ1 Thr224Met or APOB Arg3527Gln mutation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion: approximately 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion: approximately 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion: approximately 4 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Uptake of cascade screening among all first-degree relatives

Secondary outcome measures

Anxiety regarding method of contact questionnaire

Knowledge of disease and variant questionnaire

Number of new cases detected among all first-degree family members

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Direct contactExperimental Treatment1 Intervention

Study team contact of family members

Group II: Indirect contactActive Control1 Intervention

Proband initiated contact of family members

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor

688 Previous Clinical Trials

374,456 Total Patients Enrolled

1 Trials studying Long QT Syndrome

131 Patients Enrolled for Long QT Syndrome

Media Library

Direct contact of family members for cascade screening of relevant variants Clinical Trial Eligibility Overview. Trial Name: NCT05348564 — N/A

Long QT Syndrome Research Study Groups: Direct contact, Indirect contact

Long QT Syndrome Clinical Trial 2023: Direct contact of family members for cascade screening of relevant variants Highlights & Side Effects. Trial Name: NCT05348564 — N/A

Direct contact of family members for cascade screening of relevant variants 2023 Treatment Timeline for Medical Study. Trial Name: NCT05348564 — 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 still opportunities for individuals to join the clinical trial?

"Affirmative. According to the clinicaltrials.gov page, this medical investigation is actively seeking participants since its initial posting on May 1st 2023 and last update on April 17th 2023. 200 people are needed from one research facility for the trial."

Answered by AI

What is the maximum number of participants that can enroll in this trial?

"Affirmative. According to clinicaltrials.gov, this scientific trial is still in need of volunteers. It was first made available on May 1st 2023 and has been modified as recently April 17th 2023. The aim is to recruit 200 individuals from a single medical site for the experiment's duration."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparing Direct vs Indirect Methods for Cascade Screening

Amber Beitelshees 2023. "Comparing Direct vs Indirect Methods for Cascade Screening". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05348564.

All > Long Qt Syndrome