UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023878
Receipt number R000027505
Scientific Title The Impact of Exercise Treatment on Blood Flow of Lower Limb in Patients with Peripheral Artery Disease: an Wave-intensity analysis
Date of disclosure of the study information 2016/09/01
Last modified on 2022/03/12 14:56:23

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Basic information

Public title

The Impact of Exercise Treatment on Blood Flow of Lower Limb in Patients with Peripheral Artery Disease: an Wave-intensity analysis

Acronym

The Impact of Exercise Treatment on Blood Flow of Lower Limb in Patients with Peripheral Artery Disease

Scientific Title

The Impact of Exercise Treatment on Blood Flow of Lower Limb in Patients with Peripheral Artery Disease: an Wave-intensity analysis

Scientific Title:Acronym

The Impact of Exercise Treatment on Blood Flow of Lower Limb in Patients with Peripheral Artery Disease

Region

Japan


Condition

Condition

Peripheral artery disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the mechanism of an blood flow increase after exercise treatment or injection of papaverine on lower limbs using an combined pressure and flow wire (Combo wire, Volcano corporation)

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The change of pressure and blood flow after exercise treatment and injection of papaverine

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Maneuver

Interventions/Control_1

Insertion of Combo wire

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

85 years-old >

Gender

Male and Female

Key inclusion criteria

Patients who have symptomatic peripheral artery disease with one-sided or bilateral occluded iliac artery lesions

Key exclusion criteria

1. Patients with allergic to contrast media
2. Patients who is decided into inadequate for this study by attending physician

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masaharu Ishihara

Organization

Hyogo College of Medicine

Division name

Division of cardiovascular disease and coronary heart disease

Zip code


Address

1-1, Mukogawa-cho, Nishinomiya, Hyogo, Japan

TEL

0798-45-6111

Email

horitetsu.59123@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Tetsuo Horimatsu

Organization

Hyogo College of Medicine

Division name

Division of cardiovascular disease and coronary heart disease

Zip code


Address

1-1, Mukogawa-cho, Nishinomiya, Hyogo, Japan

TEL

0798-45-6111

Homepage URL


Email

horitetsu.59123@gmail.com


Sponsor or person

Institute

Hyogo College of Medicine

Institute

Department

Personal name



Funding Source

Organization

Hyogo College of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2016 Year 09 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


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

Terminated

Date of protocol fixation

2016 Year 08 Month 01 Day

Date of IRB

2016 Year 08 Month 01 Day

Anticipated trial start date

2016 Year 09 Month 01 Day

Last follow-up date

2020 Year 09 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 08 Month 31 Day

Last modified on

2022 Year 03 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027505


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name