Actively Recruiting

Age: 29Days +
All Genders
NCT06552052

A Retrospective and Prospective Natural History of Genetic Vasculopathies

Led by Massachusetts General Hospital · Updated on 2025-05-08

50

Participants Needed

1

Research Sites

216 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study will combine retrospective review of medical records from patients with ACTA2 and ongoing collection of clinical data using standardized instruments and intervals on an observational basis from patients with ACTA2. Patients in cohorts 1-3 will be asked to attend clinic visits in person per the schedule of events. At minimum, the medical records of patients with ACTA2 will be reviewed to record data on aspects of the disease, including disease characteristics and developmental milestones. The study is planned to enroll a total of 100 patients: 7 in cohort 1, 7 in cohort 2, and the remaining in cohorts 3 and 4. This study is planned to study patients for at least 3 years with the option to continue as long as possible for assessment of disease progression. During their continued study participation, as patients age, they may move into the next cohort. Beyond 3 years the duration of the study with be determined by availability of funding from sponsors.

CONDITIONS

Official Title

A Retrospective and Prospective Natural History of Genetic Vasculopathies

Who Can Participate

Age: 29Days +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed ACTA2 pathogenic variant
  • Medical records available from birth documenting disease characteristics and developmental milestones
  • Two parents and/or legal guardians who speak English and can read, understand, and sign informed consent
  • Ability to tolerate travel to the study site
Not Eligible

You will not qualify if you...

  • Does not meet the inclusion criteria
  • Currently pregnant

AI-Screening

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Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

A

Anna V Lynch, BA

CONTACT

D

Diana Tambala, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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