Ignite Creation Date:
2024-10-25 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06552052
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-01-04
Brief Title:
R-P NH of Genetic Vasculopathies
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Retrospective and Prospective Natural History of Genetic Vasculopathies
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None