UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000034768 |
|---|---|
| Receipt number | R000039630 |
| Scientific Title | Effects of cardiac therapeutic interventions on cerebral blood flow |
| Date of disclosure of the study information | 2018/11/07 |
| Last modified on | 2021/11/08 08:49:30 |
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Basic information
Public title
Effects of cardiac therapeutic interventions on cerebral blood flow
Acronym
Cerebral blood flow changes from cardiac therapeutic interventions
Scientific Title
Effects of cardiac therapeutic interventions on cerebral blood flow
Scientific Title:Acronym
Cerebral blood flow changes from cardiac therapeutic interventions
Region
| Japan |
Condition
Condition
chronic thromboembolic pulmonary hypertension and atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test if balloon pulmonary angioplasty and catheter ablation improve cerebral perfusion in patients with chronic thromboembolic pulmonary hypertension and those with atrial fibrillation, respectively.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cerebral blood flow
Key secondary outcomes
Psychological test scores
Correlations between cerebral blood flow and psychological test scores
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
| 45 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients are diagnosed as chronic thromboembolic pulmonary hypertension in fully meeting with the following criteria 1-3.
1.Chronic thrombi detected by perfusion scintigraphy, pulmonary angiography, and/or contrast computed tomography.
2.Mean pulmonary artery pressure more or equal with 25mmhg
3.Pulmonary artery wedge pressure less or equal with 15mmHg
Paroxysmal and persistent atrial fibrillation are defined as atrial fibrillation which returns to sinus rhythm within 7 days and that persisting more than 7 days, respectively.
Key exclusion criteria
1.Patients with organic brain diseases such as dementia and massive cerebral stroke
2.Patients with unstable hemodynamic and/or respiratory conditions
3.Patients with psychiatric diseases
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Suzuki |
Organization
Tohoku Medical Megabank Ogranization
Division name
Department of community medical supports
Zip code
980-8573
Address
2-1, Seiryo, Aoba, Sendai, Japan
TEL
022-717-7153
hd.suzuki.1870031@cardio.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Suzuki |
Organization
Tohoku Medical Megabank Ogranization
Division name
Department of community medical supports
Zip code
980-8573
Address
2-1, Seiryo, Aoba, Sendai, Japan
TEL
022-717-7153
Homepage URL
hd.suzuki.1870031@cardio.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Ethics application office in Tohoku University Hospital
Address
Sendai, Aoba, Seiryo, 1-1
Tel
022-717-7122
ec@rinri.hosp.tohoku.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
| 2018 | Year | 11 | Month | 07 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000039630
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
24
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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cerebral blood flow measurement with 99mTC ECD SPECT
Management information
Registered date
| 2018 | Year | 11 | Month | 05 | Day |
Last modified on
| 2021 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039630
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
