RecruitingNot a traditional drug phaseobservationalRules rewrite

Not a traditional drug phase: MRI for Cardiovascular Disease

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.

Official registry: https://clinicaltrials.gov/study/NCT05072483 · National Heart, Lung, and Blood Institute (NHLBI) · enrollment listed as 155

What this phase means

This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.

They plan to enroll about 155 people at Bethesda. Taking part typically means using or being fitted with a device plus check-ins.

Official title (unrewritten)

Natural History Study of CADASIL

Interventions: MRI

Primary outcome (registry wording): This study will examine the pathogenesis of CADASIL through comprehensive clinical evaluations and molecular studies on biospecimens collected under this protocol from affected individuals.

Who it is for (from inclusion criteria)

Ages 18 Years to 100 Years
Eligibility for this study may be determined based on information collected under other NHLBI-approved protocols, outside records and patient report
In order to be eligible to participate in this study, an individual must meet criteria 1 \& 2 and either criteria 3 or 4:
Stated willingness to comply with all study procedures and availability for the duration of the study
Male or female, aged 18 to 100 years (inclusive)
Established diagnosis of CADASIL or NOTCH3 mutations, as determined by genetic testing

Who the registry excludes

An individual who meets any of the following criteria will be excluded from participation in this study:
Pregnancy at time of consent
Subjects who lack capacity to consent and don't have a legally authorized representative
Subjects who decline to provide samples for blood and/or tissue studies
Subjects whose scans or examinations show unexpected brain conditions (outside of CADASIL) which would interfere with interpretation of testing
Subjects unable to undergo an MRI scan or subjects meeting the following criteria:
Subjects who have internal non-MRI compatible metals (i.e., cardiac pacemaker, brain stimulator, shrapnel, surgical metal, clips in the brain or on blood vessels, cochlear implants, artificial heart valves or metal fragments in the eye) as these rendering an MRI unsafe

Public study contact (from the registry)

Ruth C Brower, R.N.

(301) 443-6036

ruth.brower@nih.gov

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

National Institutes of Health Clinical Center — Bethesda, Maryland (recruiting)

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FAQ about this NCT record

Is NCT05072483 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05072483?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05072483?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary