UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029899
Receipt number R000034155
Scientific Title A novel interpretation method of fractional flow reserve derived from CT (FFR-CT)
Date of disclosure of the study information 2017/12/30
Last modified on 2018/05/26 21:28:55

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Basic information

Public title

A novel interpretation method of fractional flow reserve derived from CT (FFR-CT)

Acronym

A novel interpretation method of fractional flow reserve derived from CT (FFR-CT)

Scientific Title

A novel interpretation method of fractional flow reserve derived from CT (FFR-CT)

Scientific Title:Acronym

A novel interpretation method of fractional flow reserve derived from CT (FFR-CT)

Region

Japan


Condition

Condition

Ischemic coronary disease

Classification by specialty

Medicine in general Cardiology Radiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In this study, we explore which paramers derived from FFRCT have better diagnostic performance for the detection of ischemia compared with invasive FFR as the refference standard.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The primary endpoint was diagnostic characteristics including area under curve (AUC), accuracy, sensitivity, and specificity for detection of ischemia of CCTA and quantitative parameters derived from FFR-CT.

Key secondary outcomes



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

30 years-old <=

Age-upper limit

90 years-old >

Gender

Male and Female

Key inclusion criteria

Consecutive patients who underwent CCTA with FFR-CT analysis followed by invasive FFR measurement

Key exclusion criteria

1) Patients with history of prior coronary artery bypass graft surgery or percutaneous coronary intervention
2 )Patients with unstable symptom.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hidenobu Takagi

Organization

Iwate Medical University

Division name

Department of Radiology

Zip code


Address

19-1, Uchimaru, Morioka, Iwate

TEL

019-651-5111

Email

hdnb69tkg@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Hidenobu Takagi

Organization

Iwate Medical University

Division name

Department of Radiology

Zip code


Address

19-1, Uchimaru, Morioka, Iwate

TEL

019-651-5111

Homepage URL


Email

hdnb69tkg@gmail.com


Sponsor or person

Institute

Department of Radiology, Iwate Medical University

Institute

Department

Personal name



Funding Source

Organization

Japan Science and Technology Agency

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


Address


Tel


Email



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

2017 Year 12 Month 30 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

Completed

Date of protocol fixation

2017 Year 08 Month 01 Day

Date of IRB


Anticipated trial start date

2017 Year 09 Month 01 Day

Last follow-up date


Date of closure to data entry

2017 Year 10 Month 31 Day

Date trial data considered complete

2017 Year 10 Month 31 Day

Date analysis concluded

2018 Year 07 Month 31 Day


Other

Other related information

This study is retrospective observational study.
Study enrollment has already closed.


Management information

Registered date

2017 Year 11 Month 09 Day

Last modified on

2018 Year 05 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034155


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name