UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025047
Receipt number R000028664
Scientific Title Usefulness of cardiac computed tomography in aortic stenosis patients
Date of disclosure of the study information 2016/12/01
Last modified on 2021/05/18 09:32:44

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Basic information

Public title

Usefulness of cardiac computed tomography in aortic stenosis patients

Acronym

Usefulness of cardiac computed tomography in aortic stenosis patients

Scientific Title

Usefulness of cardiac computed tomography in aortic stenosis patients

Scientific Title:Acronym

Usefulness of cardiac computed tomography in aortic stenosis patients

Region

Japan


Condition

Condition

Aortic stenosis

Classification by specialty

Cardiology Radiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to evaluate the influence of various parameters (CT strain, LIE-CT, CT-ECV) obtained from cardiac CT on prognosis in patients with aortic stenosis.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To evaluate the feasibility of left ventricular CT MP-strain, LIE-CT, CT-ECV for predicting outcome: all-cause mortality, cardiac death, hospitalization due to heart failure, therapeutic effect (aortic valve replacement, transcatheter aortic valve implantation, transcatheter aortic valve replacement )

Key secondary outcomes

1) To evaluate CT MP-strain value compared with strain value derived from cardiac MRI or US.
2) To compare CT MP-strain with cardiac anatomical, functional or myocardial characteristic information measured by cardiac MRI or US (left ventricular ejection fraction, wall thickness, myocardial volume, late gadolinium enhancement, T1 mapping, T2 mapping, phase contrast)
3) To evaluate other parameters from CT strain analysis (Strain rate, minimum principal strain etc.)
4) To evaluate LIE-CT/CT-ECV derived from cardiac CT compared with LGE-MRI/ECV derived from cardiac MRI.


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Patients who were diagnosed with aortic stenosis clinically and underwent coronary CT angiography
2.Over 20 years old

Key exclusion criteria

1.Clinically unstable patients (Acute myocardial infarction, unstable angina, and malignant arrhythmia)
2.Patients with a history of hypersensitivity to iodine or iodinated contrast media
3.Patients who are pregnant or breastfeeding
4.When the research director or the research subinvestigator determines that it is not appropriate to participate in the research

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Yuki
Middle name
Last name Tanabe

Organization

Ehime University Graduate School of Medicine

Division name

Department of Radiology

Zip code

7910295

Address

Shitsukawa, Toon City, Ehime

TEL

089-960-5371

Email

yuki.tanabe.0225@gmail.com


Public contact

Name of contact person

1st name Yuki
Middle name
Last name Tanabe

Organization

Ehime University Graduate School of Medicine

Division name

Department of Radiology

Zip code

7910295

Address

Shitsukawa, Toon City, Ehime

TEL

089-960-5371

Homepage URL


Email

yuki.tanabe.0225@gmail.com


Sponsor or person

Institute

Ehime University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Nothing

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ehime University Hospital Clinical Research Support Center

Address

Shitsukawa, Toon City, Ehime

Tel

089-960-5914

Email

cttc@m.ehime-u.ac.jp


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



Other administrative information

Date of disclosure of the study information

2016 Year 12 Month 01 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

Open public recruiting

Date of protocol fixation

2016 Year 10 Month 07 Day

Date of IRB

2016 Year 11 Month 28 Day

Anticipated trial start date

2016 Year 12 Month 01 Day

Last follow-up date

2026 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Single center prospective study


Management information

Registered date

2016 Year 11 Month 29 Day

Last modified on

2021 Year 05 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028664


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name