UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024479
Receipt number R000028143
Scientific Title The Impact of FFR and iFR in Patients with Severe Aortic Stenosis
Date of disclosure of the study information 2016/10/19
Last modified on 2020/11/12 10:57:32

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Basic information

Public title

The Impact of FFR and iFR in Patients with Severe Aortic Stenosis

Acronym

The Impact of FFR and iFR in Patients with Severe Aortic Stenosis

Scientific Title

The Impact of FFR and iFR in Patients with Severe Aortic Stenosis

Scientific Title:Acronym

The Impact of FFR and iFR in Patients with Severe Aortic Stenosis

Region

Japan


Condition

Condition

Aortic valve stenosis

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Fractional flow reserve (FFR) is a standard technique to assess the functional severity of coronary artery stenosis in the catheterization laboratory, whereas the instantaneous wave-free ratio (iFR) is being introduced as a new non-pharmacologic-stress index of coronary stenosis severity. The iFR could have great advantages in patients with severe aortic valve stenosis (AS), to evaluate physiologically intermediate coronary artery stenosis, because iFR measurement does not require pharmacologic stress test. However, its performance has not been explored yet. The aim of this research is to establish the impact of iFR in intermediate coronary artery stenosis in patients with severe AS.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Factorial analysis between ischemic score and iFR / FFR

Key secondary outcomes

Factorial analysis between iFR and FFR


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

a. Patients consented with this clinical research.
b. Coronary angiography demonstrated more than 50% diameter stenosis by visual estimation.

Key exclusion criteria

a. contra-indication to ATP
b. lesion with chronic total occlusion
c. acute myocardial infarction within 3 months
d. inadequate lesion for FFR/iFR
e. vessels which connected to bypass graft
f. severe renal dysfunction
g. hemodialysis patients

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shigeru Saito

Organization

Shonankamakura General Hospital

Division name

Department of Cardiology and Catheterization Laboratory

Zip code


Address

1370-1 Okamoto, Kamakura, Kanagawa, Japan

TEL

0467-46-1717

Email

transradial@kamakuraheart.org


Public contact

Name of contact person

1st name
Middle name
Last name Futoshi Yamanaka

Organization

Shonankamakura General Hospital

Division name

Department of Cardiology and Catheterization Laboratory

Zip code


Address

1370-1 Okamoto, Kamakura, Kanagawa, Japan

TEL

0467-46-1717

Homepage URL


Email

futoshi-yamanaka@nifty.com


Sponsor or person

Institute

Shonankamakura General Hospital

Institute

Department

Personal name



Funding Source

Organization

Shonankamakura General Hospital

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

2016 Year 10 Month 19 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

2015 Year 04 Month 06 Day

Date of IRB

2015 Year 04 Month 06 Day

Anticipated trial start date

2015 Year 04 Month 07 Day

Last follow-up date

2018 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

no comment to declare


Management information

Registered date

2016 Year 10 Month 19 Day

Last modified on

2020 Year 11 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028143


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name