UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038948
Receipt number R000044413
Scientific Title The change in the conditions of the patients pre and post TAVI
Date of disclosure of the study information 2019/12/23
Last modified on 2023/04/23 22:09:55

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Basic information

Public title

The change in the conditions of the patients pre and post TAVI

Acronym

The change in the conditions of the patients pre and post TAVI

Scientific Title

The change in the conditions of the patients pre and post TAVI

Scientific Title:Acronym

The change in the conditions of the patients pre and post TAVI

Region

Japan


Condition

Condition

Heyde's syndrome

Classification by specialty

Medicine in general Gastroenterology Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The primary outcome measure in this study was the AS-related clinical outcome, the proportion of patients who underwent gastrointestinal endoscopic examinations and the proportion of patients who had gastrointestinal angiodysplasia.

Basic objectives2

Others

Basic objectives -Others

The secondary outcome was the change in the conditions of the patients pre and post TAVI.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The primary outcome measure in this study was the AS-related clinical outcome, the proportion of patients who underwent gastrointestinal endoscopic examinations and the proportion of patients who had gastrointestinal angiodysplasia.

Key secondary outcomes

The secondary outcome was the change in the conditions of the patients pre and post TAVI.


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

Other

Interventions/Control_1

Gastrointestinal endoscopic examinations

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

100 years-old >

Gender

Male and Female

Key inclusion criteria

Patients who underwent TAVI for severe AS with anemia or positive fecal occult blood test.

Key exclusion criteria

Patients were excluded if they had any of the following: a condition of infection or severe organ failure, a history of inflammatory bowel disease.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Yoshito
Middle name
Last name Itoh

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

602-8566

Address

465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan

TEL

0752515519

Email

yitoh@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name Ken
Middle name
Last name Inoue

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code

602-8566

Address

65, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan

TEL

(075)251-5519

Homepage URL


Email

keninoue71@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name



Funding Source

Organization

Kyoto Prefectural University of Medicine

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

Ethical Review Committee of the Kyoto Prefectural University of Medicine

Address

465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan

Tel

0752515337

Email

rinri@koto.kpu-m.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

2019 Year 12 Month 23 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

2019 Year 10 Month 07 Day

Date of IRB

2019 Year 10 Month 07 Day

Anticipated trial start date

2019 Year 12 Month 11 Day

Last follow-up date

2024 Year 03 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

2019 Year 12 Month 21 Day

Last modified on

2023 Year 04 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044413


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name