Hereditary Hemorrhagic Telangiectasia and Neurovascular Manifestations, in the Danish HHT Database (DAN-HEMTEL-VM)
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ClinicalTrials.gov Identifier: NCT05933330 |
Recruitment Status :
Recruiting
First Posted : July 6, 2023
Last Update Posted : July 14, 2023
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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.
Condition or disease | Intervention/treatment |
---|---|
Telangiectasia, Hereditary Hemorrhagic Intracranial Arteriovenous Malformations | Other: Brain MRI |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 300 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 3 Years |
Official Title: | Hereditary Hemorrhagic Telangiectasia (HHT) and Its Diverse Neurological Manifestations: Unraveling the Intricacies of an Enigmatic Disorder |
Actual Study Start Date : | April 1, 2022 |
Estimated Primary Completion Date : | March 31, 2025 |
Estimated Study Completion Date : | June 30, 2025 |
Group/Cohort | Intervention/treatment |
---|---|
Danish HHT patient 18-65 years of age |
Other: Brain MRI
All included patients receive an MRI of the brain |
- Number of new patients with Cerebral Arteriovenous malformation [ Time Frame: 1st of April 2022 - 30th of June 2025. ]MRI verified arteriovenous malformation
- Number of new patients with Ischemic stroke [ Time Frame: 1st of April 2022 - 30th of June 2025. ]Symptomatic or silent (MRI verified) Ischemic cerebral stroke
- Number of new patients with Hemorrhagic stroke [ Time Frame: 1st of April 2022 - 30th of June 2025. ]spontaneous CAVM rupture.
- Short Form 26 [ Time Frame: 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. ]Results from questionnaire SF-36. 0-100. 100 being the best possible.
- MRI arterial spin labeling (ASL) [ Time Frame: 1st of April 2022 - 30th of June 2025. ]comparison between conventional MRI angio sequences compared to MRI with ASL, in it´s ability to detect CAVM.
- Becks Depression Inventory II [ Time Frame: 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. ]Results from questionnaire BDI II. 0-61. 61 being the most depressed possible, and 0 the "best".
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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- HHT according to the clinical diagnostic criteria (curacao)
- 18-65 years of age.
- registered in the Danish HHT-database
Exclusion Criteria:
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05933330
Denmark | |
Danish HHT-center. Odense University Hospital | Recruiting |
Odense, Fyn, Denmark, 5000 | |
Contact: Mikkel Seremet Kofoed, M.D. 26167984 mikkel.seremet.kofoed@rsyd.dk | |
Principal Investigator: Mikkel Seremet Kofoed, M.D. | |
Sub-Investigator: Anette Drøhse Kjeldsen, M.D. Professor | |
Sub-Investigator: Troels Halfeld Nielsen, M.D. Ph.D. | |
Sub-Investigator: Alex Alban Christensen, M.D. Ph.D. | |
Sub-Investigator: Pernille Tørring, M.D. Ph.D. | |
Sub-Investigator: Bibi Lange, M.D. Ph.D. |
Responsible Party: | Odense University Hospital |
ClinicalTrials.gov Identifier: | NCT05933330 |
Other Study ID Numbers: |
OP_1656 |
First Posted: | July 6, 2023 Key Record Dates |
Last Update Posted: | July 14, 2023 |
Last Verified: | July 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | All data from the study, will be stored according to danish legislation and GDPR, in certified GDPR servers at OUH, after study completion. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Intracranial Arteriovenous Malformations Telangiectasis Arteriovenous Malformations Telangiectasia, Hereditary Hemorrhagic Congenital Abnormalities Vascular Diseases Cardiovascular Diseases Vascular Malformations Cardiovascular Abnormalities Hemostatic Disorders |
Hemorrhagic Disorders Hematologic Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Central Nervous System Vascular Malformations Nervous System Malformations Intracranial Arterial Diseases |