UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047327 |
|---|---|
| Receipt number | R000053979 |
| Scientific Title | Evaluation of microcirculatory function of the pulmonary artery in pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2023/04/04 13:26:15 |
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Basic information
Public title
Evaluation of microcirculatory function of the pulmonary artery in pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
Acronym
Evaluation of microcirculatory function of the pulmonary artery in pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
Scientific Title
Evaluation of microcirculatory function of the pulmonary artery in pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
Scientific Title:Acronym
Evaluation of microcirculatory function of the pulmonary artery in pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
Region
| Japan |
Condition
Condition
Pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
Classification by specialty
| Cardiology | Vascular surgery | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the safety and efficacy of a cardiac catheterization test for the pulmonary artery's microcirculatory function, which may allow to diagnose the pathological condition in pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension before and after the treatments.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Safety: the presence or absence of injuries of pulmonary arteries during and /or after the catheterization study.
Efficacy: symptoms (NYHA functional classification, WHO functional classification, emphasis-10, Specific Activity Scale), 6-minute walk distance 3-12 months after treatment intervention.
Key secondary outcomes
Serum concentrations of BNP and ureic acid, pulmonary artery pressure, pulmonary artery resistance, cardiac index, index of microvascular resistance, etc. 3-12 months after treatment intervention.
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
| Device,equipment | Maneuver |
Interventions/Control_1
Microcirculatory function of the pulmonary artery is quantified by measurement of hemodynamic variables in the artery with a commercial wire for coronary artery.
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
Patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension in the status of WHO classification: II-III
Key exclusion criteria
Patients with allergy to contrast media
Patients with bronchial asthma
Patients in pregnancy and lactation
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kazunori |
| Middle name | |
| Last name | Yamaji |
Organization
Kurume University School of Medicine
Division name
Division of Cardio-Vascular Medicine, Department of Internal Medicine
Zip code
830-0011
Address
67 Asahi-machi, Kurume
TEL
0942-31-7562
yamaji_kazunori@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Ken-ichiro |
| Middle name | |
| Last name | Sasaki |
Organization
Kurume University School of Medicine
Division name
Division of Cardio-Vascular Medicine, Department of Internal Medicine
Zip code
830-0011
Address
67 Asahi-machi, Kurume
TEL
0942-31-7562
Homepage URL
sasaken@med.kurume-u.ac.jp
Sponsor or person
Institute
Division of Cardiovascular Medicine, Department of Internal Medicine, Kurume University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science and Technology (MEXT)
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
Kurume University Hospital Clinical Research Center
Address
67 Asahi-machi, Kurume
Tel
0942-65-3749
i_rinri@kurume-u.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
| 2022 | Year | 04 | 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 | 08 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 01 | 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
| 2022 | Year | 03 | Month | 30 | Day |
Last modified on
| 2023 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053979
