Cascade Testing for High Cholesterol

FM
Overseen ByFamily Medicine Research Study Coordinators
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to evaluate the effectiveness of two models of cascade testing in identifying at-risk family members of individuals diagnosed with familial hypercholesterolemia (FH).

Who Is on the Research Team?

EJ

Elisa J. Houwink, MD, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults (18+) diagnosed with familial hypercholesterolemia (FH) who have at least one close relative willing to participate and use email. Their relatives, aged 1 or older, can join if they are first- or second-degree family members and able to give consent. People who've already done structured cascade testing can't join.

Inclusion Criteria

Index Patients: Identified through REP or Tapestry databases
Index Patients: Able and willing to provide informed consent
Index Patients: At least one eligible first- or second-degree relative
See 7 more

Exclusion Criteria

Index Patients: Prior participation in structured cascade testing
Index Patients: Insufficient clinical follow-up (<5 years)
Index Patients: No identifiable or contactable relatives
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Data Collection

Collection of demographics and FH-related history via REDCap; LDL-C values abstracted from EMR

2 weeks

Intervention

Relatives in the intervention arm receive FMTT sputum kits and educational materials; genetic testing facilitated

12 months
Ongoing contact as needed

Control

Relatives may seek genetic testing independently; no structured outreach provided

12 months

Follow-up

Participants receive surveys at 1, 3, and 12 months; follow-up for positive genetic findings

12 months
Surveys at 1, 3, and 12 months

What Are the Treatments Tested in This Trial?

Trial Overview

The study compares two ways of reaching out to families of people with FH—standard care versus a method called cascade testing—to see which better identifies relatives at risk for high cholesterol. Participation involves electronic communication and consent.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Structured OutreachExperimental Treatment1 Intervention
Group II: Usual CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+