Pulsatility Index, Vasomotor Reactivity and Leukoencephalopathy in Fabry Patients
Association of the Pulsatility Index and Vasomotor Reactivity With White Matter Lesions in Brain MRI of Fabry Disease Patients
1 other identifier
observational
45
1 country
1
Brief Summary
We hypothesize that Fabry disease - FD is associated with elevated vascular resistance induced by cerebral small-vessel disease, indicating increased distal resistance to blood flow. The findings of this study may be used as a precursor for neuroimaging manifestations related to stroke in FD patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2020
CompletedFirst Posted
Study publicly available on registry
October 6, 2020
CompletedStudy Start
First participant enrolled
November 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2023
CompletedNovember 9, 2023
November 1, 2023
1.6 years
September 29, 2020
November 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Prevalence of elevated pulsatility index of FD patients
to assess the prevalence of elevated pulsatility index in FD patients at a single time point.
2 years
Prevalence of elevated vasomotor reactivity in FD patients.
to assess the prevalence of elevated vasomotor reactivity in FD patients at a single time point.
2 years
Secondary Outcomes (4)
Association of pulsalitily index with leukoencephalopathy in FD patients.
2 years
Association of vasomotor reactivity with leukoencephalopathy in FD patients.
2 years
Τo compare the pulsatility index measured in FD patients against corresponding prospectively collected data from healthy individuals, stratified by age and sex.
2 years
Τo compare vasomotor reactivity measured in FD patients against corresponding prospectively collected data from healthy individuals, stratified by age and sex.
2 years
Study Arms (2)
Fabry disease
Healthy
age and sex matched
Interventions
Transcranial Doppler (TCD) and Transcranial Color-Coded Duplex (TCCD) ultrasonography will be performed in consecutive FD patients. All TCD and TCCD studies will be performed by stroke neurologists experienced in vascular sonography.
Eligibility Criteria
Consecutive patients with genetically confirmed FD and healthy individuals will be prospectively enrolled as part of routine clinical examination.
You may qualify if:
- Fabry disease diagnosis, genetically confirmed Age\> 16 years
You may not qualify if:
- Insufficient temporal bone window MRI contra-indication Inability to cooperate for breath-holding test Detection of atrial fibrillation Refuse to sing informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Second Department of Neurology, "Attikon" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece
Athens, 12462, Greece
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 29, 2020
First Posted
October 6, 2020
Study Start
November 20, 2020
Primary Completion
July 1, 2022
Study Completion
January 20, 2023
Last Updated
November 9, 2023
Record last verified: 2023-11