UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043272
Receipt number R000049389
Scientific Title Coronary and esophageal testing in patients with chest pain
Date of disclosure of the study information 2021/04/01
Last modified on 2024/02/10 09:46:01

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Basic information

Public title

Coronary and esophageal testing in patients with chest pain

Acronym

Coronary and esophageal testing in patients with chest pain

Scientific Title

Coronary and esophageal testing in patients with chest pain

Scientific Title:Acronym

Coronary and esophageal testing in patients with chest pain

Region

Japan


Condition

Condition

Chest pain syndrome

Classification by specialty

Gastroenterology Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the relation between angina including vasospastic and microvascular angina and esophageal disorders such as gastroesophageal reflux disease and esophageal achalasia in patients with chest pain

Basic objectives2

Others

Basic objectives -Others

Clinical diagnostic study

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The prevalence of angina and esophageal disorders and their relations

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who have chest pain and are planned for coronary and upper gastrointestinal testing

Key exclusion criteria

Patients with no consent

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Yuichi
Middle name
Last name Saito

Organization

Chiba University Hospital

Division name

Department of Cardiovascular Medicine

Zip code

260-0856

Address

1-8-1 Inohana, Chuo-ku, Chiba, Japan

TEL

043-222-7171

Email

saitoyuichi1984@gmail.com


Public contact

Name of contact person

1st name Yuichi
Middle name
Last name Saito

Organization

Chiba University Hospital

Division name

Department of Cardiovascular Medicine

Zip code

260-0856

Address

1-8-1 Inohana, Chuo-ku, Chiba, Japan

TEL

043-222-7171

Homepage URL


Email

saitoyuichi1984@gmail.com


Sponsor or person

Institute

Chiba University Hospital

Institute

Department

Personal name



Funding Source

Organization

Scholarship donation

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

Chiba University Graduate School of Medicine

Address

1-8-1 Inohana, Chuo-ku, Chiba, Japan

Tel

043-222-7171

Email

inohana-soumu1@chiba-u.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



Other administrative information

Date of disclosure of the study information

2021 Year 04 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

Enrolling by invitation

Date of protocol fixation

2020 Year 11 Month 04 Day

Date of IRB

2020 Year 12 Month 18 Day

Anticipated trial start date

2021 Year 01 Month 29 Day

Last follow-up date

2023 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

N/A


Management information

Registered date

2021 Year 02 Month 07 Day

Last modified on

2024 Year 02 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049389


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name