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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034768
Receipt No. R000039630
Official scientific title of the study Effects of cardiac therapeutic interventions on cerebral blood flow
Date of disclosure of the study information 2018/11/07
Last modified on 2018/11/07

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Basic information
Official scientific title of the study Effects of cardiac therapeutic interventions on cerebral blood flow
Title of the study (Brief title) 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 Hideaki Suzuki
Organization Tohoku Medical Megabank Ogranization
Division name Department of community medical supports
Address 2-1, Seiryo, Aoba, Sendai, Japan
TEL 022-717-7153
Email hd.suzuki.1870031@cardio.med.tohoku.ac.jp

Public contact
Name of contact person Hideaki Suzuki
Organization Tohoku Medical Megabank Ogranization
Division name Department of community medical supports
Address 2-1, Seiryo, Aoba, Sendai, Japan
TEL 022-717-7153
Homepage URL
Email hd.suzuki.1870031@cardio.med.tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 11 Month 05 Day
Anticipated trial start date
2018 Year 11 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information Cerebral blood flow measurement with 99mTC ECD SPECT

Management information
Registered date
2018 Year 11 Month 05 Day
Last modified on
2018 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039630

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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