UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056022 |
|---|---|
| Receipt number | R000064023 |
| Scientific Title | A Multicenter Observational Study of the Clinical Significance of Computed Tomography Delayed Enhancement in Patients with Atrial Fibrillation |
| Date of disclosure of the study information | 2024/11/02 |
| Last modified on | 2024/11/02 09:45:53 |
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Basic information
Public title
A Multicenter Observational Study of the Clinical Significance of Computed Tomography Delayed Enhancement in Patients with Atrial Fibrillation
Acronym
CODE-AF
Scientific Title
A Multicenter Observational Study of the Clinical Significance of Computed Tomography Delayed Enhancement in Patients with Atrial Fibrillation
Scientific Title:Acronym
CODE-AF
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiology | Radiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the clinical significance of computed tomography delayed enhancement in patients with atrial fibrillation
Basic objectives2
Others
Basic objectives -Others
diagnostic / prognostic value
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence of cardiac amyloidosis
Key secondary outcomes
Heart failure hospitalization
Hemorrhagic events
Recurrent atrial fibrillation
Change in left atrial volume
Presence and extent of myocardial fibrosis
Improvement in physical function
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 undergoing catheter ablation for atrial fibrillation
Key exclusion criteria
Rejection
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Yamada |
Organization
Yokohama City University School of Medicine
Division name
Division of Cardiology
Zip code
2360004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
0457872718
yamada.yu.iu@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Masaaki |
| Middle name | |
| Last name | Konishi |
Organization
Yokohama City University School of Medicine
Division name
Division of Cardiology
Zip code
2360004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
245-787-2718
Homepage URL
m_koni@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
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
Yokohama City University Certified Institutional Review Board
Address
3-9 Fukuura, Kanazawa-ku
Tel
045-370-7933
ynext@yokohama-cu.ac.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
| 2024 | Year | 11 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1) Background information: age, gender, height, weight, smoking history, drinking history, medical history, complications, medication history
2) Preoperative heart failure severity
3) Questionnaire: IPAQ (International Physical Activity Questionnaire), EQ5D (EuroQol-5Dimention)
4) Vital signs
5) Blood test results (preoperative, postoperative, and at outpatient follow-up): Hematology (white blood cell count, white blood cell fraction, hemoglobin, hematocrit) Biochemical tests (total protein, serum albumin, CRP, BUN, serum creatinine, uric acid, Na, K, Cl, HbA1c, total cholesterol, LDL cholesterol, BNP (brain natriuretic peptide), NT-proBNP (terminal-proBNP )) Coagulation (PT, D-dimer)
6) Imaging studies: preoperative contrast CT, transthoracic echocardiography, 12-lead EKG, Holter EKG, transesophageal echocardiography, coronary angiography, pyrophosphate scintigraphy
7) Frailty scale
8) Physical function: grip strength, SPPB (Short Physical Performance Battery), lower leg circumference, measurement of physical activity using an activity meter
9) Body composition
10) Surgical information: surgical technique, operation time, access site, sheath diameter, type of catheter used, radiation dose, anesthesia time
11) Pathological findings: presence or absence of cardiac amyloidosis, presence and extent of myocardial fibrosis, presence or absence of myocardial degeneration
12) Treatment details: drugs administered
13) Results of determination of treatment efficacy: blood tests, echocardiography, Holter electrocardiography
14) Complications and side effects and their description
15) Prognosis
Management information
Registered date
| 2024 | Year | 11 | Month | 02 | Day |
Last modified on
| 2024 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064023
