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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/15/2021.

Pulmonary Arteriovenous Malformations (PAVMs) in Hereditary Haemorrhagic Telangiectasia (HHT)

Clinicaltrials.gov identifier NCT03940014

Recruitment Status Completed

First Posted May 7, 2019

Last update posted May 7, 2019

Study Description

Brief summary:

Computed tomography (CT) is the modality of choice to characterize pulmonary arteriovenous malformations (PAVMs) in patients with hereditary haemorrhagic telangiectasia (HHT). The objective of this study was to determine if CT findings were associated with frequency of brain abscess and ischaemic stroke. This retrospective study included patients with HHT-related PAVMs. CT results, PAVM presentation (unique, multiple, disseminated or diffuse), the number of PAVMs and the largest feeding artery size, were correlated to prevalence of ischaemic stroke and brain abscess.

  • Condition or Disease:Hereditary Haemorrhagic Telangiectasia
    Pulmonary Arteriovenous Malformation
    Cerebral Disorder
  • Intervention/Treatment: Other: Data collection from standard follow up
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational
  • Actual Enrollment: 170 participants
  • Observational Model: Cohort
  • Time Perspective: Retrospective
  • Official Title: Pulmonary Arteriovenous Malformations (PAVMs) in Hereditary Haemorrhagic Telangiectasia (HHT): Correlations Between Computed Tomography Findings and Cerebral Complications
  • Actual Study Start Date: January 2014
  • Actual Primary Completion Date: March 2017
  • Actual Study Completion Date: March 2018
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: Pulmonary arteriovenous malformations
Patients with hereditary haemorrhagic telangiectasia (HHT)-related Pulmonary Arteriovenous Malformations (PAVMs). For all patients, the final diagnosis of certain HHT the diagnosis can be made depending on the presence of four criteria known as the Curaçao criteria: 1) Spontaneous recurrent epistaxis 2) Multiple telangiectasias in typical locations 3) Proven visceral Arteriovenous Malformations (AVM) (lung, liver, brain, spine) 4) First-degree family member with HHT. If conditions three or four are met, a patient has "definite HHT", while condition two is considered as "possible HHT". All patients had a molecular diagnosis and all follow-up clinical assessments were available in the database.
Other: Data collection from standard follow up
Annual clinical consultation with an Hereditary Haemorrhagic Telangiectasia (HHT) specialist and/or pneumologist and organ specialists when necessary (such as hepatologists, cardiologists and neurologists). Explorations (contrast echography, chest Computed Tomography and treatments performed according to international guidelines. TransCatheter Embolotherapy for each treatable Pulmonary Arteriovenous Malformations (PAVMs) and follow-up every 3 years. Chest Computed Tomography (CT) every 6-12 months.
Outcome Measures
  • Primary Outcome Measures: 1. Yearly change in chest Computed Tomography (CT) results in patients with Hereditary Haemorrhagic Telangiectasia (HHT). [ Time Frame: Every year for 10 years ]
    The presence of pulmonary arteriovenous malformations (PAVMs) (unique, multiple, disseminated or diffuse, the number of PAVMs and the largest feeding artery size) upon examination by CT could be correlated to the frequency of brain abscess and ischemic stroke in patients with hereditary haemorrhagic telangiectasia (HHT). These patients underwent a yearly CT scan to check for PAVM presence.
Eligibility Criteria
  • Ages Eligible for Study: (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Non-Probability Sample
  • Study Population: Hereditary Haemorrhagic Telangiectasia (HHT) Patients who had a molecular diagnosis and all follow-up clinical assessments available in the database.
Criteria

Inclusion Criteria:

- Hereditary Haemorrhagic Telangiectasia (HHT) diagnosis

- Pulmonary Arteriovenous Malformations (PAVMs) related with HHT

Exclusion Criteria:

- Clinical follow-up not available in the database

Contacts and Locations
Contacts
Locations
Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator: Salim Si-Mohamed, MD Hospices Civils de Lyon (Hôpital cardiologique Louis Pradel)

More Information
  • Responsible Party: Hospices Civils de Lyon
  • ClinicalTrials.gov Identifier: NCT03940014 History of Changes
  • Other Study ID Numbers: PAVM
  • First Posted: May 7, 2019 Key Record Dates
  • Last Update Posted: May 7, 2019
  • Last Verified: May 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Congenital Abnormalities
    Hemangioma
    Telangiectasis
    Arteriovenous Malformations
    Telangiectasia, Hereditary Hemorrhagic
    Arteriovenous Fistula