Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pulsatility Aneurysmal Evaluation Process by Cerebral Dynamic CTA (Computed Tomography Angiography) (PULSAN)

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: NCT03535181
Recruitment Status : Enrolling by invitation
First Posted : May 24, 2018
Last Update Posted : February 14, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Brief Summary:

Intracranial aneurysm are frequent with a prevalence estimated over 2-5% in the general population. These are focal dilatations occuring in the cerebral vessels. They usually remain silent until complications occur. Complications associated with intracranial aneurysms include mass effect on adjacent structures and rupture. Rupture is the most severe complication with a mortality rate of 35-50% and a high rate of morbidity including long-term disability. It incidence is estimated about 1% per year for aneurysm smaller than 1 cm.

However, preventative treatments have their own risk of complication and morbi-mortality rate including stroke and hemorrhage. Actual guidelines for treatment planning are mainly designed with the size, the location and the age of the patient. This is why working on the identification of imaging markers of aneurysmal instability is relevant.

Dynamic CTA (Computed Tomography Angiography) acquisition allow to study the variation of metrics such as dome height, dome length, ostium width, ostium area, and volume during the cardiac cycle. The goal of this study is to assess different aneurysmal metrics to determine those which may vary the most during the cardiac cycle and to assess it as an imaging marker of aneurysmal instability.


Condition or disease
Aneurysm, 4D CT Scan

Layout table for study information
Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Pulsatility Aneurysmal Evaluation Process by Cerebral Dynamic CTA (Computed Tomography Angiography)
Actual Study Start Date : April 20, 2018
Estimated Primary Completion Date : December 15, 2021
Estimated Study Completion Date : December 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms CT Scans




Primary Outcome Measures :
  1. Assess the variation of different aneurysmal metrics (dome height, dome length, ostium width, ostium area, and volume) during the cardiac cycle. [ Time Frame: 6months ]
    Is there a difference between the maximum and the minimum values ? Measurements are realised with a 4D computed tomography angiography.


Secondary Outcome Measures :
  1. Evaluate among different aneurysmal metrics (dome height, dome length, ostium width, ostium area, and volume) the most relevant ones. [ Time Frame: 6months ]
    Evaluate among different aneurysmal metrics (dome height, dome length, ostium width, ostium area, and volume) for a composite endpoint including those which may vary the most during the cardiac cycle (maximum minus minium values) and which have the best reproducibilities over one (intrareader agreement) and multiples cardiac cycles.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients suffering from at least one intracranial aneurysm and who benefited from a 4D CTA in our institution.
Criteria

Inclusion Criteria:

  • Patient with an intracranial aneurysm assessed with a 4D CTA

Exclusion Criteria:

  • Minor
  • Refusal to participate

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): NCT03535181


Locations
Layout table for location information
France
CHRU de Brest
Brest, France, 29609
Sponsors and Collaborators
University Hospital, Brest

Layout table for additonal information
Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT03535181    
Other Study ID Numbers: PULSAN (29BRC18.0073)
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: February 14, 2020
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Aneurysm
Vascular Diseases
Cardiovascular Diseases