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NCT01158807 · ClinicalTrials.gov registry record
Cerebral Hemorrhage Risk in Hereditary Hemorrhagic Telangiectasia
A clinical trial of Hereditary Hemorrhagic Telangiectasia, sponsored by Unity Health Toronto.
- Active
- Registry status
- 2,272
- Enrollment target
- 19
- Study locations
NCT01158807 is a study of Hereditary Hemorrhagic Telangiectasia that is active but no longer recruiting, run by Unity Health Toronto. The registered enrollment target is 2,272 participants, above the 1,466-participant average among 7 other Hereditary Hemorrhagic Telangiectasia trials with a reported enrollment target (55% higher). The trial reports 19 study locations across 16 states.
The verdict
NCT01158807, a study of Hereditary Hemorrhagic Telangiectasia, is active but no longer recruiting, sponsored by Unity Health Toronto.
- ACTIVE NOT RECRUITING
- Registry status
- 2,272 participants
- Enrollment target
- 19
- Study locations
Study Summary
This study is one of the three projects of an NIH Rare Disease Clinical Research Consortium. A "consortium" is a group of centres sharing information and resources to perform research. The consortium research focuses on brain blood vessel malformations in three different rare diseases. The focus of this specific study is on Hemorrhagic Telangiectasia (HHT). HHT is a condition characterized by blood vessel malformations, called telangiectasia and arteriovenous malformations (AVMs), occurring in the brain, nose, lungs, stomach, bowels and liver. Brain AVMs (BAVMs) in HHT are difficult to study because they are rare, affecting approximately 10% of people with HHT. While other types of BAVMs have been studied in depth, studies in the HHT population have been very small. Here, we propose the first large-scale collaboration by joining with 12 HHT Centers of Excellence in North America to perform a large study of risk factors for bleeding from BAVMs, called intracranial hemorrhage (ICH) in HHT patients. The current standard of clinical practice across North America, is to screen all HHT patients for BAVMs with magnetic resonance imaging (MRI). If BAVMs are detected, patients are referred to a multidisciplinary neurovascular team for consideration for treatment. Treatment decisions are made on a case by case basis, balancing risks of complications from the BAVM with risks of therapy, but are limited by the few studies available in HHT. We hope that the knowledge we obtain about the risk factors for intracranial bleeding in these patients from this larger study will help us to improve the care of HHT patients. We plan to study risk factors for rupture of BAVMs, including primarily genetics and imaging characteristics of the BAVMs. Knowledge about risk factors will help in the care and management of HHT patients. This will be achieved through the collection of health information to construct a HHT database, blood sampling and banking (through the National Institute of Neu
Conditions Studied
Study Locations (19)
California
- David Geffen School of Medicine at University of California, Los Angeles - Los Angeles
- University of California, San Francisco - San Francisco
Maryland
- Johns Hopkins University School of Medicine - Baltimore
- HHT Foundation International, Inc. - Monkton
Ontario
- St. Michael's Hospital - Toronto
- Hospital for Sick Children - Toronto
Arizona
- Barrow Neurological Institute - Phoenix
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Colorado
- UCHealth Pulmonary Vascular Disease Clinic - Anschutz Medical - Aurora
Connecticut
- Yale University - New Haven
Georgia
- Georgia Regents University - Augusta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,272 participants |
| Start Date | 2010-04-08 |
| Est. Completion | 2025-06-30 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01158807
The ClinicalTrials.gov registry entry for NCT01158807 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 2,272 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,466-participant average among 7 other Hereditary Hemorrhagic Telangiectasia trials with a reported enrollment target (55% higher). The listed sponsor is Unity Health Toronto, which has 12 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hereditary Hemorrhagic Telangiectasia appearing as the primary indexed condition, and to 0 interventions.
NCT01158807 reports 19 study locations spanning 16 distinct geographic areas - top geographies include California, Maryland, Ontario.
Frequently Asked Questions
What is clinical trial NCT01158807 about?
NCT01158807 is a clinical study titled "Cerebral Hemorrhage Risk in Hereditary Hemorrhagic Telangiectasia". This study is one of the three projects of an NIH Rare Disease Clinical Research Consortium. A "consortium" is a group of centres sharing information and resources to perform research. The consortium research focuses on brain blood vessel malformations in three different rare diseases. The focus of...
What is the current status of trial NCT01158807?
This trial is currently active not recruiting. The enrollment target is 2,272 participants. The study started on 2010-04-08. Estimated completion is 2025-06-30.
What conditions does trial NCT01158807 study?
This clinical trial studies the following conditions: Hereditary Hemorrhagic Telangiectasia.
Who is sponsoring clinical trial NCT01158807?
This trial is sponsored by Unity Health Toronto, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01158807 being conducted?
This trial has 19 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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