Hereditary Hemorrhagic Telangiectasia and Neurovascular Manifestations, in the Danish HHT Database

NCT05933330 | Active Not Recruiting

• 1 other identifier: OP_1656
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

With a described prevalence of brain arteriovenous malformations (CAVM) of 12.8% in HHT patients, of whom 10% presents with intracranial hemorrhage, HHT pose a risk of devastating intracranial hemorrhage. The main objective of the study is to challenge current statements (pros and cons) regarding systematic screening of asymptomatic HHT patients for neurovascular manifestations. The investigators are thus seeking to answer a question many screening programs have faced. A screening program should screen for a manageable problem, by a method that is considered cost effective and does not cause negative effect, even when extrapolated to a large cohort. Finally, the positive effect of screening program should outweigh the negative and not cause unnecessary concerns for the patients. The investigators are seeking to draw perspectives from the results to general questions about screening programs.

Conditions

Telangiectasia, Hereditary Hemorrhagic; Intracranial Arteriovenous Malformations

Outcome Measures

Primary Outcomes (1)

• Number of new patients with Cerebral Arteriovenous malformation

  MRI verified arteriovenous malformation

  1st of April 2022 - 30th of June 2025.

Secondary Outcomes (5)

• Number of new patients with Ischemic stroke

  1st of April 2022 - 30th of June 2025.

• Number of new patients with Hemorrhagic stroke

  1st of April 2022 - 30th of June 2025.

• Short Form 26

  Baseline - inclusion, and 3 months after screening with MRI, and (in case of treatment) 3 months after treatment. 1st of April 2022 - 30th of June 2025.

• MRI arterial spin labeling (ASL)

  1st of April 2022 - 30th of June 2025.

• Becks Depression Inventory II

  Baseline - inclusion, and 3 months after screening with MRI, and (in case of treatment) 3 months after treatment. 1st of April 2022 - 30th of June 2025.

Study Arms (1)

Danish HHT patient 18-65 years of age

Other: Brain MRI

Interventions

Brain MRI OTHER

All included patients receive an MRI of the brain

Danish HHT patient 18-65 years of age

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with HHT (according to the curacao criteria or genetically verified mutations)

You may qualify if:

• HHT according to the clinical diagnostic criteria (curacao)
• years of age.
• registered in the Danish HHT-database

You may not qualify if:

• patients has received an MRI of the brain with angio sequences, within the last 5 years.
• contraindications to MRI
• contraindications to self-reported questionnaires (i.e. mental retardation)

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Danish HHT-center. Odense University Hospital

Odense, Fyn, 5000, Denmark

Location

MeSH Terms

Conditions

Telangiectasia, Hereditary Hemorrhagic; Intracranial Arteriovenous Malformations

Condition Hierarchy (Ancestors)

Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Telangiectasis; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Vascular Malformations; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Central Nervous System Vascular Malformations; Nervous System Malformations; Arteriovenous Malformations; Intracranial Arterial Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: July 6, 2023
• Study Start: April 1, 2022
• Primary Completion: March 31, 2025
• Study Completion: July 31, 2025
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

DK (1)