UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044141 |
|---|---|
| Receipt number | R000049175 |
| Scientific Title | Study of formation and disappearance of gastrointestinal angiodysplasia that is associated with cardiovascular diseases with high shear stress |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2022/02/28 20:26:26 |
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Basic information
Public title
Study of formation and disappearance of gastrointestinal angiodysplasia that is associated with cardiovascular diseases with high shear stress
Acronym
Study of formation and disappearance of gastrointestinal angiodysplasia that is associated with cardiovascular diseases with high shear stress
Scientific Title
Study of formation and disappearance of gastrointestinal angiodysplasia that is associated with cardiovascular diseases with high shear stress
Scientific Title:Acronym
Study of formation and disappearance of gastrointestinal angiodysplasia that is associated with cardiovascular diseases with high shear stress
Region
| Japan |
Condition
Condition
Severe aortic stenosis, mitral regurgitation, implantable ventricular assist device placement, obscure gastrointestinal bleeding
Classification by specialty
| Gastroenterology | Cardiology | Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the actual condition of gastrointestinal vascular dysplasia associated with cardiovascular disease.
Basic objectives2
Others
Basic objectives -Others
To clarify the risk factors for gastrointestinal vascular dysplasia associated with cardiovascular disease.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Perform gastrointestinal endoscopy to evaluate the presence, size, morphology, number, and site of onset of gastrointestinal angiodysplasia.
Key secondary outcomes
Obtain the von Willebrand factor (VWF) polymer multimer index. In addition, comprehensive hemostatic analysis of VWF antigen amount, VWF activity, PAI-1, soluble thrombomodulin, etc. will be performed.
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
| Maneuver |
Interventions/Control_1
A ,Aortic valve stenosis (AS)
For cases of AS, EGD/CS/CE are provided as insurance medical treatment before TAVI if the condition permits, but within 1 month after TAVI for cases with poor condition such as heart failure. In addition, one year after TAVI (10 to 14 months later), follow-up examination will be performed only for EGD/CS/CE that had previously confirmed gastrointestinal mucosal vascular dysplasia.
B, Mitral regurgitation (MR)
For cases of MR, EGD/CS/CE will be performed as insurance medical treatment at the time of registration.
C, New implantable left ventricular assist device (LVAD) placement case
LVAD are presumed to be associated with severe heart failure, and it is difficult to perform endoscopy before surgery. Therefore, CE is performed within 1 month of indwelling (free of charge as a study). CE 6 months after LVAD placement (4-8 months), 1 and a half years (16-20 months), and preferably 3-4 years (30-48 months) Follow up. The frequency of gastrointestinal bleeding did not decrease even several years after LVAD placement, and we would like to perform CE 3-4 years later (30-48 months later) to evaluate vascular dysplasia. Purchase of CE Research expenses have not been secured. Therefore, at present, it will be enforced if possible.
D, Gastrointestinal bleeding of unknown cause
Gastrointestinal bleeding cases of unknown causeare registered, and CE is performed as insurance medical treatment. In addition, follow-up CE will be performed only for those who had dysplasia of the gastrointestinal mucosa at the time of splenic bleeding 6 to 24 months after the initial examination.
A,B,C,D
Before CE, we perform patency capsules (PCE) as much as possible (insurance medical treatment). At the same time as endoscopy, additional blood is collected at the time of blood collection within the normal medical care range and thrombotic hemostatic analysis is performed. Evaluate cardiac function at the same time as endoscopy.
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)Aortic stenosis with anemia
(Aortic valve implantation (TAVI) cases with a catheter of hemoglobin <11.0 g / dL) 200 cases
B)30 cases of mitral regurgitation with anemia (hemoglobin <11.0 g / dL)
(AVWS also develops in mitral regurgitation, but hemodynamics are different from aortic stenosis. Therefore, mitral regurgitation is also targeted to determine the effect of hemodynamics.)
C)LVAD implantation cases:25 cases
D)Gastrointestinal bleeding of unknown cause (no obvious source of bleeding such as cancer, ulcer, inflammation, diverticulum): 50 cases
Key exclusion criteria
1) Cases with apparently serious infections and inflammation
2) Cases with serious complications (intestinal paralysis, intestinal obstruction, etc.)
3) Instability of hemodynamics
4) After gastrointestinal surgery (Post appendectomy is OK)
5) Cases suspected of gastrointestinal stenosis
6) Advanced cancer
7) Cases where other causes of anemia, such as cancer, cancer treatment, and blood disorders, can be found
8) Cases of inflammatory bowel disease
9) Other cases that doctors deem inappropriate for this study
Target sample size
305
Research contact person
Name of lead principal investigator
| 1st name | Hisanori |
| Middle name | |
| Last name | Horiuchi |
Organization
Tohoku University
Division name
Department of Molecular and Cellular Biology, Institute of Development, Aging and Cancer
Zip code
9808575
Address
4-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
TEL
022-717-8463
hisanori.horiuchi.e8@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Hisanori |
| Middle name | |
| Last name | Horiuchi |
Organization
Tohoku University
Division name
Department of Molecular and Cellular Biology, Institute of Development, Aging and Cancer
Zip code
9808575
Address
4-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
TEL
022-717-8463
Homepage URL
hisanori.horiuchi.e8@tohoku.ac.jp
Sponsor or person
Institute
Department of Molecular and Cellular Biology, Institute of Development, Aging and Cancer, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine
Address
465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku
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
| 2021 | Year | 06 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 01 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2025 | 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
| 2021 | Year | 05 | Month | 07 | Day |
Last modified on
| 2022 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049175
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| Registered date | File name |
| Research case data | |
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