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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038723


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name