UMIN-CTR Clinical Trial

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
Email	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
Email	kanai.hisato.ac@mail.hosp.go.jp

Sponsor
Institute	National Hospital Organization Yokohama Medical Center
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038723