UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008510
Receipt number R000010002
Scientific Title Evaluation of the correlation between low-dose aspirin-induced small bowel mucosal injury and cardiovascular/cerebrovascular events: multicenter prospective cohort study
Date of disclosure of the study information 2012/07/25
Last modified on 2012/07/24 11:04:43

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Basic information

Public title

Evaluation of the correlation between low-dose aspirin-induced small bowel mucosal injury and cardiovascular/cerebrovascular events: multicenter prospective cohort study

Acronym

Evaluation of the correlation between LDA-induced small bowel mucosal injury and cardiovascular/cerebrovascular events

Scientific Title

Evaluation of the correlation between low-dose aspirin-induced small bowel mucosal injury and cardiovascular/cerebrovascular events: multicenter prospective cohort study

Scientific Title:Acronym

Evaluation of the correlation between LDA-induced small bowel mucosal injury and cardiovascular/cerebrovascular events

Region

Japan


Condition

Condition

small bowel mucosal injury and cardiovascular/cerebrovascular disease

Classification by specialty

Medicine in general Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the incidence rate of cardiovascular/cerebrovascular events in low-dose aspirin users between with small bowel mucosal injuries and without small bowel mucosal injuries evaluated by capsule endoscopy

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The incidence rate of cardiovascular/cerebrovascular events

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

1. Patients who take low-dose aspirin more than three months prior this study for prevention for cardiovascular events (AP and AMI) and cerebrovascular (CI and TIA).
2. Willingness to provide written informed consent.

Key exclusion criteria

1. History of NSAIDs use within three months prior this study
2. History of inflammatory bowel disease
3. History of severe renal failure and/or hepatic failure
4. Patients with implantable pacemaker
5. Ppatients with dysphagia.
6. Patients who have history of the ileus or stricture or fistula of the intestine.
7. Patients who can not give informed consent for operation to retrieve the capsule.
8. The patients who have severe heart failure and respiratory failure.
9. Patients judged as inappropriate candidates for the trial by the investigators

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroki Endo

Organization

Yokohama City University

Division name

Division of Endoscopy

Zip code


Address

3-9, Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Yokohama City University

Division name

Division of Endoscopy

Zip code


Address

3-9, Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan

TEL


Homepage URL


Email



Sponsor or person

Institute

Yokohama City University

Institute

Department

Personal name



Funding Source

Organization

Division of Endoscopy, Yokohama City University

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

横浜市立大学病院、茅ヶ崎市立病院、平塚市民病院、小田原市立病院、横浜労災病院、町田市民病院、都立広尾病院


Other administrative information

Date of disclosure of the study information

2012 Year 07 Month 25 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

2012 Year 07 Month 24 Day

Date of IRB


Anticipated trial start date

2012 Year 07 Month 24 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The incidence rate of cardiovascular/cerebrovascular events in low-dose aspirin users


Management information

Registered date

2012 Year 07 Month 24 Day

Last modified on

2012 Year 07 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010002


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name