UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015880
Receipt number R000018452
Scientific Title Follow-up of Percutaneous Coronary Intervention (PCI) patients with Multifunction Cardiogram to (MCG)
Date of disclosure of the study information 2014/12/20
Last modified on 2014/12/09 10:05:11

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Basic information

Public title

Follow-up of Percutaneous Coronary Intervention (PCI) patients with Multifunction Cardiogram to (MCG)

Acronym

Follow-up of Percutaneous Coronary Intervention (PCI) patients with Multifunction Cardiogram to (MCG)

Scientific Title

Follow-up of Percutaneous Coronary Intervention (PCI) patients with Multifunction Cardiogram to (MCG)

Scientific Title:Acronym

Follow-up of Percutaneous Coronary Intervention (PCI) patients with Multifunction Cardiogram to (MCG)

Region

Japan


Condition

Condition

Patients recieved percutaneous coronary intervention

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to evaluate the usefulness of MCG for follow-up over a long period of time to patients who underwent PCI.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To evaluate the ability of MCG to monitor temporal change of ischemic conditions due to significant in-stent restenosis or nascent new stenosis following PCI procedures

Key secondary outcomes

(1) To evaluate the ability of MCG to monitor temporal change of ischemic conditions due to PCI-related complications
(2) To evaluate the ability of MCG to quantitatively detect significant myocardial ischemia of patients tested positive via FFR
(3) To evaluate the ability of MCG to quantitatively detect varying degrees of myocardial ischemia of patients having collateral circulation formation


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

21 years-old <=

Age-upper limit

85 years-old >

Gender

Male and Female

Key inclusion criteria

Patients received percutaneous coronary intervention

Key exclusion criteria

Patients with CABG or valve repalacement, acute myocardial infarction, congestive heart faiulre, cardiogenic shock, poor record of MCG and whose physitians judge not suitable.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tadayuki Uetani

Organization

Chubu Rosai Hospital

Division name

Cardiology

Zip code


Address

1-10-6, Komei, Minato-ku, Ngoya 465-8530 Japan

TEL

052-652-5511

Email

shinoda.cvm@chubuh.rofuku.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Norihiro Shinoda

Organization

Chubu Rosai Hospital

Division name

Cardiology

Zip code


Address

Minato-ku, Ngoya 465-8530 Japan

TEL

052-652-5511

Homepage URL


Email

shinoda.cvm@chubuh.rofuku.go.jp


Sponsor or person

Institute

Department of cardiology, Chubu Rosai Hospital

Institute

Department

Personal name



Funding Source

Organization

none

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

2014 Year 12 Month 20 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

Enrolling by invitation

Date of protocol fixation

2013 Year 06 Month 23 Day

Date of IRB


Anticipated trial start date

2014 Year 06 Month 23 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2014 Year 12 Month 09 Day

Last modified on

2014 Year 12 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018452


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name