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NCT05072483 · ClinicalTrials.gov registry record
Natural History Study of CADASIL
A clinical trial of Cardiovascular Disease and Arterial Stiffness, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Recruiting
- Registry status
- 155
- Enrollment target
- 1
- Study location
NCT05072483: Recruiting study of Cardiovascular Disease and Arterial Stiffness, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT05072483 is a study of Cardiovascular Disease and Arterial Stiffness that is actively recruiting participants, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 155 participants, below the 2,696-participant average among 137 other Cardiovascular Disease trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05072483, a study of Cardiovascular Disease and Arterial Stiffness, is actively recruiting participants, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- RECRUITING
- Registry status
- 155 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: CADASIL (cerebral autosomal dominant arteriopathy with subcortical infarct and leukoencephalopathy) is a genetic disorder. It causes narrowing of the small blood vessels and can lead to strokes and dementia. Researchers want to monitor people with CADASIL over time. Objective: To learn more about how CADASIL affects a person s blood vessels over time. Eligibility: Adults ages 18 and older who have CADASIL, and healthy volunteers. Design: Participants will be screened with a medical record review. Participants will have 4 study visits over 9 years. Visits will last 6 8 hours per day, for 2 4 days. Participants will give blood and urine samples. They will have an electrocardiogram to record their heart s electrical activity. They will fill out a family tree. They will have tests that measure mental abilities like memory and attention. They may have a skin biopsy. They may have a lumbar puncture. Participants will have an eye exam. Their pupils will be dilated. They will receive a dye via intravenous (IV) line. Pictures will be taken of their eyes. Participants will have an imaging scan of their brain. They may receive a contrast agent via IV. Participants blood flow and blood vessel flexibility will be measured. In one test, a probe will be pressed against the skin of the their wrist, neck, and groin. In another test, they will hold one arm still while a microscope makes videos of the blood flow through a fingernail. In another test, they will perform light exercise or other activities while wearing an elastic band around their head or probes placed on their arm or leg. Healthy volunteers will complete some of the above tests.
Primary Outcome
To study the pathogenesis of CADASIL and obtain clinical evaluations and biospecimens from affected cohorts to identify underlying disease mechanism(s).
Conditions Studied
Interventions
- DEVICE MRI
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 155 participants |
| Start Date | 2022-04-18 |
| Est. Completion | 2041-06-01 |
What NCT05072483 shows while recruiting
NCT05072483 is an observational study that tracks outcomes without assigning an intervention. The registered 155 participants enrollment target is mid-sized for trials with a published cap, below the 2,696-participant average among 137 other Cardiovascular Disease trials with a reported enrollment target (94% lower).
The record links to 5 conditions, with Cardiovascular Disease appearing as the primary indexed condition, and to 1 intervention - of which MRI is the first listed.
NCT05072483 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05072483 about?
NCT05072483 is a clinical study titled "Natural History Study of CADASIL". Background: CADASIL (cerebral autosomal dominant arteriopathy with subcortical infarct and leukoencephalopathy) is a genetic disorder. It causes narrowing of the small blood vessels and can lead to strokes and dementia. Researchers want to monitor people with CADASIL over time. Objective: To lear...
What is the current status of trial NCT05072483?
This trial is currently recruiting. The enrollment target is 155 participants. The study started on 2022-04-18. Estimated completion is 2041-06-01.
What conditions does trial NCT05072483 study?
This clinical trial studies the following conditions: Cardiovascular Disease, Arterial Stiffness, Germline Mutation in the NOTCH 3 Gene, Pathogenesis of CADASIL, Clinical Phenotype of CADASIL.
What interventions are being tested in trial NCT05072483?
The interventions under investigation include: MRI (DEVICE).
Who is sponsoring clinical trial NCT05072483?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05072483 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05072483's enrollment target sits among peer trials
155 59th of 137 higher than 79 of 137 other Cardiovascular Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiovascular Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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