UMIN-CTR Clinical Trial

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
Last 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
1st 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