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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036195
Receipt No. R000041200
Scientific Title The Serum CA-125 levels in Atrial Fibrillation
Date of disclosure of the study information 2019/03/14
Last modified on 2019/03/15

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Basic information
Public title The Serum CA-125 levels in Atrial Fibrillation
Acronym CA-125 AF
Scientific Title The Serum CA-125 levels in Atrial Fibrillation
Scientific Title:Acronym CA-125 AF
Region
Japan

Condition
Condition Atrial Fibrillation
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigated the relationship the serum CA-125 level and the incidence of atrial fibrillation in the patients aged over 65 years old with peace maker
Basic objectives2 Others
Basic objectives -Others Analysis of patients' characteristics
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of Atrial Fibrillation
Key secondary outcomes 1.Exploratory analysis of the patient background
2.The result of the biomaker
3.The ratio of the permanent atrial fibrillation from the paroxysmal atrial fibrillation
4.The incidence of the cardiovascular disease
5.The recurrence of atrial fibrillation after the procedure of pulmonary vein isolation

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
65 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria 1.The male patients aged over 65 years old at the obtaining informed consent
2.The patients implanted pacemakers over 3 months ago
3.The patients with sinus rhythm at the enrollment
4.The patients implanted atrial pacing lead
5.The patients who have obtained written informed consent after sufficient explanation in advance of participating in this study

Key exclusion criteria 1.Patients presenting shock (systolic blood pressure <90 mmHg)
2.Patients with decompensated heart failure
3.Patients with atrial flutter, atrial tachycardia, permanent atrial fibrillation or long standing atrial fibrillation
4.Patients with bronchiectasis
5.Patients with pancreatic cancer, lung cancer, or colon cancer
6.Patients undergoing chemotherapy or radiation therapy for malignant tumors
7.Patients with severe infections or severe trauma, or within 2 weeks after surgery
8.Patients whose doctors judged them as unsuited to participate in this clinical study
Target sample size 850

Research contact person
Name of lead principal investigator
1st name HARUKI
Middle name
Last name SEKIGUCHI
Organization National Hospital Organization
Division name Clinical Research Department
Zip code 245-8575
Address 3-60-2 Harajyuku, Totsuka-ku, Yokohama, Kanagawa
TEL 045-851-2621
Email sekiguchi.haruki@twmu.ac.jp

Public contact
Name of contact person
1st name Yoshimi
Middle name
Last name Seki
Organization National Hospital Organization Yokohama Medical Center
Division name Clinical Research Department
Zip code 245-8575
Address 3-60-2 Harajyuku, Totsuka-ku, Yokohama, Kanagawa
TEL 045-851-2621
Homepage URL
Email seki.yoshimi.nq@mail.hosp.go.jp

Sponsor
Institute National Hospital Organization
Institute
Department

Funding Source
Organization National Hospital Organization
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 National Hospital Organization
Address 2-5-21 Higashigaoka, Meguro, Tokyo
Tel 03-5712-5075
Email 700-kenkyu@mail.hosp.go.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
2019 Year 03 Month 14 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
2018 Year 12 Month 18 Day
Date of IRB
2018 Year 12 Month 18 Day
Anticipated trial start date
2019 Year 03 Month 14 Day
Last follow-up date
2022 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2019 Year 03 Month 14 Day
Last modified on
2019 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041200

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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