UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033949 |
|---|---|
| Receipt number | R000038723 |
| Scientific Title | The Effect Which Hot Compresses to waist and back during percutaneous coronary intervention exerts on autonomic nervous system. |
| Date of disclosure of the study information | 2018/09/01 |
| Last modified on | 2022/10/16 11:09:16 |
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Basic information
Public title
The Effect Which Hot Compresses to waist and back during percutaneous coronary intervention exerts on autonomic nervous system.
Acronym
HOT-PCI
Scientific Title
The Effect Which Hot Compresses to waist and back during percutaneous coronary intervention exerts on autonomic nervous system.
Scientific Title:Acronym
HOT-PCI
Region
| Japan |
Condition
Condition
Ischemic heart disease
Classification by specialty
| Cardiology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1)To evaluate the effect of hot compresses to waist and back at the time of percutaneous coronary intervention on autonomic nervous system by Lorenz Plot Analysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Heart rate variation analysis (Lorentz Plot Analysis).
Key secondary outcomes
1) Adverse events.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
As an intervention group, the patients are warmed with a bath towel, and with hot compressed to the waist and back using 3MTM Bair-huggerTM patient warming system During percutaneous coronary intervention.
Interventions/Control_2
As a control group, the patients are warmed with a bath towel during percutaneous coronary intervention.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient who receives PCI for the first time.
Key exclusion criteria
1.Patients with atrial fibrillation.
2.Patients with diabetes.
3.Patients with heart failure or circulatory insufficiency.
4.Patients performing PCI on more than two branches of the coronary arteries.
5.Patients with restlessness.
6.Patients who use ME devices such as IABP during treatment.
7.Patients who receive treatment of rotablator.
8.Patients with high risk of burns.
9.Patients with sensory paralysis.
10.Patient who needs informed consent.
11.Pediatric patients who need informed assent.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hisato |
| Middle name | |
| Last name | Kanai |
Organization
National Hospital Organization
Yokohama Medical Center
Division name
Nursing Department
Zip code
245-8575
Address
3-60-2 Harajyuku Totsuka-ku, Yokohama city Kanagawa 245-8575 Japan
TEL
+81-45-851-2621
kanai.hisato.ac@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Hisato |
| Middle name | |
| Last name | Kanai |
Organization
National Hospital Organization Yokohama Medical Center
Division name
Nursing Department
Zip code
245-8575
Address
3-60-2 Harajyuku Totsuka-ku, Yokohama city Kanagawa 245-8575 Japan
TEL
+81-45-851-2621
Homepage URL
kanai.hisato.ac@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization
Yokohama Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Yokohama Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Yokohama Medical Center
Address
3-60-2 Harajyuku Totsuka-ku, Yokohama city Kanagawa 245-8575 Japan
Tel
+81-45-851-2621
219sy01@hosp.go.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
独立行政法人国立病院機構横浜医療センター(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
https://confit.atlas.jp/guide/event/nms76/subject/P1-2-364/advanced
Publication of results
Published
Result
URL related to results and publications
https://confit.atlas.jp/guide/event/nms76/subject/P1-2-364/advanced
Number of participants that the trial has enrolled
40
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
Main results already published
Date of protocol fixation
| 2018 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 12 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 10 | Month | 16 | Day |
Date trial data considered complete
| 2022 | Year | 10 | Month | 16 | Day |
Date analysis concluded
| 2022 | Year | 10 | Month | 16 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 29 | Day |
Last modified on
| 2022 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038723
