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
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
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
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
