UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050235 |
|---|---|
| Receipt number | R000057215 |
| Scientific Title | Association of skin color change with respiratory and circulatory status in patients undergoing transcatheter aortic valve implantation |
| Date of disclosure of the study information | 2023/02/04 |
| Last modified on | 2024/08/09 13:43:24 |
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Basic information
Public title
Association of skin color change with respiratory and circulatory status in patients undergoing transcatheter aortic valve implantation
Acronym
Skin color change in patients undergoing transcatheter aortic valve implantation
Scientific Title
Association of skin color change with respiratory and circulatory status in patients undergoing transcatheter aortic valve implantation
Scientific Title:Acronym
Skin color change in patients undergoing transcatheter aortic valve implantation
Region
| Japan |
Condition
Condition
Aortic valve stenosis, transcatheter aortic valve implantation (TAVI)
Classification by specialty
| Cardiology | Intensive care medicine | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to clarify whether facial color changes during postoperative period, time course changes in skin color from pre- to 72-hr after-TAVI are measured using spectrophotometer. Factors associated with skin color is investigated.
Basic objectives2
Others
Basic objectives -Others
Clinical pathophysiology
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
skin color, CIE1976L*b*a*
Key secondary outcomes
Relationship between L*a*b* and laboratory data or vital sign
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
| 65 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. more than 65 years to less than 90 years old
3. Patients with TAVI scheduled in the morning
4. Persons who have been fully informed and have given written consent of their own free will.
Key exclusion criteria
1. Skin lesions (rash, trauma, scarring, etc.) at the measurement site.
2. Diseases that cause pigmentation (hyperthyroidism, liver cirrhosis, chronic renal failure, etc.)
3. Patients with dementia
4. Persons deemed inappropriate by the principal investigator/assigned investigator
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | Kutsuzawa |
| Last name | Kutsuzawa |
Organization
Tokai University
Division name
School of Medicine, Faculty of Nursing
Zip code
259-1193
Address
143 Shimokasya, Iehara, Kanagawa
TEL
0463931121
tkutsu@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Kutsuzawa |
Organization
Tokai University
Division name
School of Medicine, Faculty of Nursing
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
0463931121
Homepage URL
tkutsu@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Tomoko Kutsuzawa
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)
IRB Contact (For public release)
Organization
Institutional Review Board for Clinical Research, Tokai University
Address
143 Shimokasuya, Isehara, Kanagawa
Tel
0463931121
tokai-rinsho@ml.tokai-u.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
| 2023 | Year | 02 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1002/col.22952
Number of participants that the trial has enrolled
11
Results
The skin lightness L* values increased at 6 and 18 h after TAVI and returned at 72 h after TAVI and a* values decreased at 6 h after TAVI. No associations were observed between the changes in skin color and changes in BP or laboratory data.
Results date posted
| 2024 | Year | 08 | Month | 09 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Submitted to a journal in the field of intensive medicine in 2023, but was not accepted; submitted to a journal in the field of color in February 2024, and was accepted in July 2024.
Date of the first journal publication of results
| 2024 | Year | 08 | Month | 08 | Day |
Baseline Characteristics
Patients with symptomatic aortic stenosis aged 65-90 years. Patients with skin pigmentation, such as liver cirrhosis, end-stage renal failure, endocrine disorders, tattoos, wounds, or burns at the measurement site, were excluded.
Participant flow
Adverse events
None
Outcome measures
Skin color: L*,a*, b*, BP, SpO2, Laboratory data (WBC, hemoglobin, hematocrit, bilirubin, albumin, CRP)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 05 | Month | 28 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 13 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 03 | Day |
Date of closure to data entry
| 2022 | Year | 11 | Month | 02 | Day |
Date trial data considered complete
| 2022 | Year | 11 | Month | 02 | Day |
Date analysis concluded
| 2023 | Year | 02 | Month | 04 | Day |
Other
Other related information
We measure time course changes in skin color from pre- to 72-hr after-TAVI using spectrophotometer to clarify whether facial color changes during postoperative period.
To investigate relationships between skin color and blood pressure or hemoglobin.
Management information
Registered date
| 2023 | Year | 02 | Month | 04 | Day |
Last modified on
| 2024 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057215
