UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055919 |
|---|---|
| Receipt number | R000063899 |
| Scientific Title | A Prospective Observational Study Evaluating Lung Drug Clearance Using Isosorbide Dinitrate as a Probe. |
| Date of disclosure of the study information | 2024/10/23 |
| Last modified on | 2024/12/21 10:25:43 |
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Basic information
Public title
A Prospective Observational Study Evaluating Lung Drug Clearance Using Isosorbide Dinitrate as a Probe.
Acronym
A Prospective Observational Study Evaluating Lung Drug Clearance Using Isosorbide Dinitrate as a Probe.
Scientific Title
A Prospective Observational Study Evaluating Lung Drug Clearance Using Isosorbide Dinitrate as a Probe.
Scientific Title:Acronym
A Prospective Observational Study Evaluating Lung Drug Clearance Using Isosorbide Dinitrate as a Probe.
Region
| Japan |
Condition
Condition
Patients scheduled for both heart catheterization and endomyocardial biopsy, with planned use of isosorbide dinitrate (ISDN) During the Procedure.
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether isosorbide dinitrate is cleared in the lungs.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Insantaneous Extraction Ratio (ER) of Isosorbide Dinitrate in the lung.
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for both heart catheterization and endomyocardial biopsy
Patients planned to have a sheath placed in the radial artery
Patients expected to receive 1.0 mg or more of isosorbide dinitrate injection (5 mg/10 mL) during coronary angiography.
Individuals aged 18 years or older and 85 years or younger at the time of consent
Patients with a BMI (Body Mass Index) of 18.0 kg/m2 or higher and 35.0 kg/m2 or lower at screening.
Patients who have provided written consent
Key exclusion criteria
AST and ALT levels exceeding three times the upper limit of normal values.
Serum creatinine levels exceeding 1.5 times the upper limit of normal values.
Requirement for continuous oxygen therapy due to pulmonary disease.
Decompensated heart failure at the time of consent.
Patients diagnosed with severe valvular disease by echocardiography.
Deemed unsuitable for this study by the investigator.
Exclusion Criteria for Lab Values Obtained During Cardiac Catheterization
Cardiac Index (CI) obtained by the thermodilution method is 1.8 L/min/m2 or below.
Pulmonary Artery Wedge Pressure (PAWP) is 18 mmHg or higher.
Pulmonary Vascular Resistance (PVR) calculated as (mean PAP - PAWP) / CO is 3.0 Wood or higher, or mean PAP is 25 mmHg or higher.
A sheath could not be placed in the radial artery.
The physician deems the administration of Isosorbide Dinitrate inappropriate due to reasons such as hypotension.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Naoto |
| Middle name | |
| Last name | Uemura |
Organization
Oita University
Division name
Department of Clinical Pharmacology and Therapeutics
Zip code
8795593
Address
1-1 Idaigaoka, Hasama-Machi, Yufu-Shi, Oita, 879-5593 Japan
TEL
0975865952
khayashi@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Hayashi |
Organization
Oita University
Division name
Department of Clinical Pharmacology and Therapeutics
Zip code
8795593
Address
1-1 Idaigaoka, Hasama-Machi, Yufu-Shi, Oita, 879-5593 Japan
TEL
0975865952
Homepage URL
khayashi@oita-u.ac.jp
Sponsor or person
Institute
Oita University
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI Grant Number 22K06701
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nagoya City University Department of Cardiology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Oita University Ethics Committee
Address
1-1 Idaigaoka, Hasama-Machi, Yufu-Shi, Oita, 879-5593 Japan
Tel
0975865952
rinrikenkyu@oita-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
| 2024 | Year | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2024 | Year | 10 | Month | 22 | Day |
Last modified on
| 2024 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063899
