UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006814
Receipt number R000008060
Scientific Title Investigation of coronary spasm for left ventricular dysfunction
Date of disclosure of the study information 2011/12/01
Last modified on 2011/12/01 16:22:01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Investigation of coronary spasm for left ventricular dysfunction

Acronym

Investigation of coronary spasm for left ventricular dysfunction

Scientific Title

Investigation of coronary spasm for left ventricular dysfunction

Scientific Title:Acronym

Investigation of coronary spasm for left ventricular dysfunction

Region

Japan


Condition

Condition

coronary spasm

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We investigate the role of coronary spasm for left ventricular dysfunction.

Basic objectives2

Others

Basic objectives -Others

pathophysiological examination

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

result of acetylcholine provocation test
therapeutic efficacy for left ventricular dysfunction

Key secondary outcomes



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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

left ventricular ejection fraction less than 55% by echocardiography

Key exclusion criteria

cardiac sarcoidosis
cardiac amyloidosis
Fabry Disease

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takumi Inami

Organization

Kyorin University School of Medicine

Division name

Second Department of Internal Medicine

Zip code


Address

Shinkawa 6-20-2, Mitaka, Tokyo

TEL

0422-47-5511

Email



Public contact

Name of contact person

1st name
Middle name
Last name Takumi Inami

Organization

Kyorin University School of Medicine

Division name

Second Department of Internal Medicine

Zip code


Address


TEL


Homepage URL


Email

z4z4z4z4@hotmail.co.jp


Sponsor or person

Institute

Kyorin University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

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

2011 Year 12 Month 01 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Open public recruiting

Date of protocol fixation

2007 Year 01 Month 01 Day

Date of IRB


Anticipated trial start date

2007 Year 01 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We performed acetylcholine provocation test to the patients with left ventricular dysfunction, and investigated the degree of improvement of left ventricular dysfunction after medical treatment based on results of acetylcholine provocation test.


Management information

Registered date

2011 Year 12 Month 01 Day

Last modified on

2011 Year 12 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008060


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name