UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019349 |
|---|---|
| Receipt number | R000022361 |
| Scientific Title | Validation of integrated backscatter of ultrasound for the quantification of aortic valve calcifications in patients with calcifying aortic valve disease, compared to computed tomography Agatston score. |
| Date of disclosure of the study information | 2015/10/14 |
| Last modified on | 2015/10/15 16:26:48 |
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Basic information
Public title
Validation of integrated backscatter of ultrasound for the quantification of aortic valve calcifications in patients with calcifying aortic valve disease, compared to computed tomography Agatston score.
Acronym
Quantification of aortic valve calcifications with echocardiography, compared to CT.
Scientific Title
Validation of integrated backscatter of ultrasound for the quantification of aortic valve calcifications in patients with calcifying aortic valve disease, compared to computed tomography Agatston score.
Scientific Title:Acronym
Quantification of aortic valve calcifications with echocardiography, compared to CT.
Region
| Europe |
Condition
Condition
Aortic valve disease
Classification by specialty
| Cardiology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Quantification of aortic valve calcifications with backscatter analysis of echocardiography.
Basic objectives2
Others
Basic objectives -Others
Comparison of echocardiography with CT for aortic valve calcification quantification.
Investigation of prognostic value of echocardiographic backscatter in aortic valve disease.
Investigation of the correlation of backscatter analysis with degree of aortic valve stenosis.
Evaluation of the effect of ultrasound equipment settings on backscatter analysis.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation of echocardiographic backscatter with CT Agatston score.
Key secondary outcomes
Correlation of echocardiographic backscatter with degree of aortic valve stenosis.
Correlation of backscatter with aortic valve stenosis prognosis and outcome.
Correlation of backscatter with degree of aortic valve sclerosis.
Effect of ultrasound settings on backscatter analysis.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 19 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients which should be scheduled for a cardiac CT and/or patients with aortic valve disease.
Key exclusion criteria
Aortic valve mechanical prosthesis.
Pregnancy
BMI > 30
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | GILLIS Kris |
Organization
Universitair Ziekenhuis Brussel (UZ Brussel)
Division name
Cardiology
Zip code
Address
Laarbeeklaan 101, 1090 Jette, Belgium
TEL
+81-03224774991
gilliskris@yahoo.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Gillis Kris |
Organization
UZ Brussel
Division name
Cardiology
Zip code
Address
Laarbeeklaan 101, 1090 Jette, Belgium
TEL
+81-03224774991
Homepage URL
gilliskris@yahoo.com
Sponsor or person
Institute
Bernard Cosyns, MD, PhD, Head of department cardiology, UZ Brussel
Institute
Department
Personal name
Funding Source
Organization
Department of cardiology, UZ Brussels.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Universitair Ziekenhuis Brussel (UZ Brussel), Belgium.
In vivo cellular and molecular imaging laboratory (ICMI Lab), Vrije Universiteit Brussel (VUB), Belgium.
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2015 | Year | 10 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Echocardiography: short axis and long axis images.
Backscatter evaluation.
CT Agatston score of aortic valve.
Recruitment of all outpatients of the University Hospital Brussels, Belgium (UZ Brussel) who will come between December 2015 and March 2017 and match the inclusion criteria.
Management information
Registered date
| 2015 | Year | 10 | Month | 14 | Day |
Last modified on
| 2015 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022361
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| Registered date | File name |
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