UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022657 |
|---|---|
| Receipt number | R000026115 |
| Scientific Title | The ACTH stimulation test and computed tomography are useful for determining the subtype of primary aldosteronis m |
| Date of disclosure of the study information | 2016/06/08 |
| Last modified on | 2016/06/08 10:55:31 |
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Basic information
Public title
The ACTH stimulation test and computed tomography are useful for determining the subtype of primary aldosteronis m
Acronym
Useful test and value for determining the subtype of primary aldosteronism
Scientific Title
The ACTH stimulation test and computed tomography are useful for determining the subtype of primary aldosteronis m
Scientific Title:Acronym
Useful test and value for determining the subtype of primary aldosteronism
Region
| Japan |
Condition
Condition
Primary aldosteronism
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The diagnostic steps for primary aldosteronism (PA) include case screening tests, confirmatory tests, and localization. The aim of this study was to investigate useful confirmatory tests and their cut-off values for determining the subtype of primary aldosteronism, especially in unilateral PA, such as aldosterone-producing adenoma, and bilateral PA, such as idiopathic hyperaldosteronism.
Basic objectives2
Others
Basic objectives -Others
Adrenal venous sampling (AVS) is the gold-standard test to differentiate unilateral from bilateral disease. However, AVS is far from easy to perform for all patients with PA because of some problems.Therefore, bilateral cases of patients with PA should be identified in a minimally invasive manner before performing AVS.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Investigation of usefulness confirmatory test and
value for determining the subtype of primary aldosteronism
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The medical records of patients diagnosed with PA by confirmatory testing and localization by AVS were retrospectively analyzed. Ninety patients admitted to Nippon Medical School Hospital for AVS from January 2009 to March 2015 were examined. The diagnosis was confirmed by endocrinological examinations such as confirmatory tests (CCT, FUT and SIT) and ACTH-stimulated AVS (ACTH-AVS).
Key exclusion criteria
A patient who had iodine allergy and used steroid during AVS
Five patients who were diagnosed with subclinical Cushing's syndrome
Four patients taking antihypertensive drugs other than calcium channel blockers and a blockers for refractory hypertension
One patient with suspected bilateral aldosterone producing adenomas
Two patients with unsuccessful AVS
One patient who had aldosterone excess and LR over 2.6 on AVS, but CR was over 1.0
Target sample size
76
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Sugihara |
Organization
Graduate School of Medicine, Nippon Medical School
Division name
Department of Endocrinology, Diabetes and Metabolism
Zip code
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
TEL
03-3822-2131
hitoshi@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | AYAKO MORIYA |
Organization
Graduate School of Medicine, Nippon Medical School
Division name
Department of Endocrinology, Diabetes and Metabolism
Zip code
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
TEL
03-3822-2131
Homepage URL
ayako0414@nms.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medicine, Nippon Medical School
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 06 | Month | 08 | 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
Completed
Date of protocol fixation
| 2009 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective review
Management information
Registered date
| 2016 | Year | 06 | Month | 08 | Day |
Last modified on
| 2016 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026115
| 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 |
