UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041821 |
|---|---|
| Receipt number | R000047711 |
| Scientific Title | Prospective capillaroscopic observation of angiogenesis and new induction vessels by warming in systemic sclerosis |
| Date of disclosure of the study information | 2020/09/26 |
| Last modified on | 2023/12/25 16:01:56 |
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Basic information
Public title
Prospective capillaroscopic observation of angiogenesis and new induction vessels by warming in systemic sclerosis
Acronym
AGNI study
Scientific Title
Prospective capillaroscopic observation of angiogenesis and new induction vessels by warming in systemic sclerosis
Scientific Title:Acronym
AGNI study
Region
| Japan |
Condition
Condition
Systemic sclerosis
Classification by specialty
| Medicine in general | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To know whether the peripheral capillary density increase or capillary morphology change due to continuous warming in systemic sclerosis, capillaroscopic observation is performed to the patients.
Basic objectives2
Others
Basic objectives -Others
To find out if capillary changes can occur with sustained thermal stimulation.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Capillary density of the nail fold observed by capillaroscopy
Key secondary outcomes
Morphological modification of the nail fold capillary observed by capillaroscopy,
The concentrations of angiogenesis related factors in fingertip blood (angiopoietin-1, angiopoietin-2, endostatin, VEGF)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Warming the upper lateral surface areas of both elbow joints using disposable warmer pads.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients over 20 years old and under 90 years old.
2. Patients who have Raynaud's phenomenon(RP) and meet the 2013 Classification Criteria for Systemic Sclerosis (ACR/EAULAR).
3. Patients visiting the outpatient of Osaka University Hospital.
4. Patients who give written informed consent.
Key exclusion criteria
1. Another skin disease except systemic sclerosis at the site of wearing
2. Chronic febrile disease including infectious disease
3. Diabetes mellitus
4. Incapable of taking off the warmer by themselves
5. Peripheral neuropathy of upper extremities or past medical history of that
6. Vascular shunt on the arm for hemodialysis
7. Others (judged as ineligible by the responsible researcher)
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshihito |
| Middle name | |
| Last name | Shima |
Organization
Osaka University Graduate School of Medicine
Division name
Laboratory of Thermo-therapeutics for vascular dysfunction
Zip code
565-0871
Address
1-3Yamada-oka, Suita, Osaka5650871, Japan
TEL
06-6105-5710
ryanjin@imed3.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihito |
| Middle name | |
| Last name | Shima |
Organization
Osaka University Graduate School of Medicine
Division name
Laboratory of Thermo-therapeutics for vascular dysfunction
Zip code
565-0871
Address
1-3Yamada-oka, Suita, Osaka5650871, Japan
TEL
06-6105-5710
Homepage URL
ryanjin@imed3.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kobayashi Pharmaceuticals Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Clinical Research Review Committee
Address
2-2 Yamada-oka, Suita, Osaka5650871
Tel
06-6210-8289
rinri@hp-crc.med.osaka-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
| 2020 | Year | 09 | Month | 26 | Day |
Related information
URL releasing protocol
https://www.med.osaka-u.ac.jp/pub/thermo/research04.html
Publication of results
Unpublished
Result
URL related to results and publications
Unpublished
Number of participants that the trial has enrolled
20
Results
Angiopoietin-1 levels in blood at the fingertip increased after heating. This increase persisted at four weeks after the end of heating.
Capillary density changes in the anteriormost capillaries did not show a consistent trend.
The percentage of capillaries in the anterior-most row with normal hairpin shape increased after the heating.
Results date posted
| 2023 | Year | 03 | Month | 28 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
We are writing the manuscript about this study.
Date of the first journal publication of results
Baseline Characteristics
In nineteen subjects, excluding one case without any intervension for even one day,the average age was 55.9 years old, 3 males and 16 females. There were 14 patients with lcSSc and 5 patients with dcSSc. The mean disease duration was 13.3 years. The average mRSS was 4 points.
Participant flow
Twenty patients with systemic sclerosis (SSc) participated; one dropped out without a day's intervention due to hospitalization for causes other than SSc; two participants withdrew of their own volition; 17 participants completed the entire procedure.
Adverse events
The following adverse evets were observed; skin striae:1, reticular dermatitis:1, skin redness:1, burns:3, skin itching:1. Of these, 2 burns were treated with topical agents. Others recovered without treatment.
Outcome measures
Concentration of Angiopoietin-1 in fingertip blood, number of nail canal capillaries in the front row of the 4th finger observed by capillaroscopy, and their morphology
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 17 | Day |
Last modified on
| 2023 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047711
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| Registered date | File name |
| Research case data | |
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