UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026325
Receipt number R000030239
Scientific Title Relation between intraluminal intensity of blood speckle on intravascular ultrasound and fractional flow reserve
Date of disclosure of the study information 2017/03/01
Last modified on 2021/11/07 20:58:11

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Basic information

Public title

Relation between intraluminal intensity of blood speckle on intravascular ultrasound and fractional flow reserve

Acronym

Relation between intraluminal intensity of blood speckle on intravascular ultrasound and fractional flow reserve

Scientific Title

Relation between intraluminal intensity of blood speckle on intravascular ultrasound and fractional flow reserve

Scientific Title:Acronym

Relation between intraluminal intensity of blood speckle on intravascular ultrasound and fractional flow reserve

Region

Japan


Condition

Condition

Coronary artery disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluating relation between intraluminal intensity of blood speckle on intravascular ultrasound and fractional flow reserve

Basic objectives2

Others

Basic objectives -Others

Physiological assessment

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Comparison between the difference in intraluminal intensity of blood speckle (Delta IBS) and fractional flow reserve (FFR) with or without hyperemia.

Key secondary outcomes

1) Comparison between Delta IBS and instantaneous wave-free ratio (iFR) with or without hyperemia.
2) Diagnostic Accuracy of Delta IBS for physiological assessment of coronary artery stenosis by FFR with or without hyperemia.
3) Diagnostic Accuracy of Delta IBS for physiological assessment of coronary artery stenosis by iFR with or without hyperemia.
4) Diagnostic Accuracy of minimum lumen area (MLA) on intravascular ultrasound (IVUS) for physiological assessment of coronary artery stenosis.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

IVUS data acquisition and FFR measurement during percutaneous coronary intervention (PCI).

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

85 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients who scheduled to undergo PCI.

Key exclusion criteria

1) Patients with hemodialysis
2) Patients who use nhaled drugs or theophylline products for bronchial asthma
3) Patients with left main trunk lelsion or stenosis >50% at the distal to the target lesion.
4) Patients with chronic total obstruction
5) Patients with severe heart failure (ejection fraction <30% or NYHA >class 3)
6) Patients with prior coronary artery bypass grafting

Target sample size

31


Research contact person

Name of lead principal investigator

1st name Yoshio
Middle name
Last name Kobayashi

Organization

Chiba University Hospital

Division name

Department of Cardiovascular Medicine

Zip code

260-0856

Address

1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan

TEL

043-222-7171

Email

a-tamiya@chiba-u.jp


Public contact

Name of contact person

1st name Yuichi
Middle name
Last name Saito

Organization

Chiba University Hospital

Division name

Department of Cardiovascular Medicine

Zip code

260-0856

Address

1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan

TEL

043-222-7171

Homepage URL


Email

policemaccho@yahoo.co.jp


Sponsor or person

Institute

Chiba University Hospital

Institute

Department

Personal name



Funding Source

Organization

None

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

Chiba University Hospital

Address

1-8-1 Inohana, Chuo-ku, Chiba

Tel

043-222-7171

Email

takeshis@faculty.chiba-u.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

2017 Year 03 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

Terminated

Date of protocol fixation

2016 Year 11 Month 24 Day

Date of IRB

2017 Year 03 Month 01 Day

Anticipated trial start date

2017 Year 03 Month 01 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 02 Month 27 Day

Last modified on

2021 Year 11 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030239


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name