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Thoracic Aortic Dilatation Syndromes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02111668
Recruitment Status : Completed
First Posted : April 11, 2014
Last Update Posted : May 2, 2018
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:
Aortic dilatation syndromes are comprised by a group of different syndromes, of which Marfan syndrome is the best described. Many of the aorta dilatation associated syndromes are heritable connective tissue disorders but some patients do not have any other phenotypical symptoms than aorta dilatation. The genetic variation in thoracic aorta dilatation is still unknown. This study aims on genetic evaluation of patients with thoracic aorta dilatation. Furthermore the study will focus on a registry angel trying to evaluate prevalence, mortality, morbidity and socioeconomically status of Marfan syndrome patients. This part will rely on registry data obtained from unique Danish registries.

Condition or disease
Thoracic Aorta Dilatation Marfan Syndrome

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Study Type : Observational [Patient Registry]
Actual Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration: 1 Day
Official Title: Thoracic Aortic Dilatation Syndromes - Diagnostic, Incidences, Morbidity, Mortality and Socioeconomical Observations.
Study Start Date : February 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Genetic evaluation [ Time Frame: one year ]
    Evaluation of the genetic cause of thoracic aorta dilatation


Secondary Outcome Measures :
  1. Diagnosis correction [ Time Frame: One year ]
    After the genetic evaluation som patients might have another condition than expected pre genetic testing. This will be corrected.


Biospecimen Retention:   Samples With DNA
Biobank with plasma, serum and Whole blood.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with thoracic aorta dilatation
Criteria

Inclusion Criteria:

  • Thoracic aorta dilatation
  • Marfan syndrome phenotype as in the Ghent II criteria.

Exclusion Criteria:

  • None of the inclusions criteria.

Information from the National Library of Medicine

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): NCT02111668


Locations
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Denmark
Aarhus University Hospital
Aarhus, Region Midtjylland, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
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Principal Investigator: Kristian A Groth, Doctor Aarhus University / Aarhus University Hospital
Additional Information:

Publications:

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02111668    
Other Study ID Numbers: M-20110238
First Posted: April 11, 2014    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: February 2013
Keywords provided by University of Aarhus:
Aorta
Dilatation
Marfan syndrome
Genetic
Fbn1
Additional relevant MeSH terms:
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Marfan Syndrome
Arachnodactyly
Aneurysm
Syndrome
Dilatation, Pathologic
Disease
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Heart Diseases
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Connective Tissue Diseases
Limb Deformities, Congenital
Musculoskeletal Abnormalities