UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036195 |
|---|---|
| Receipt number | 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 20:13:44 |
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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
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
seki.yoshimi.nq@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041200
