UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039790 |
|---|---|
| Receipt number | R000045016 |
| Scientific Title | Impact of left ventricular stiffness by diastolic wall strain on atrial high rate episodes after pacemaker implantation |
| Date of disclosure of the study information | 2020/05/12 |
| Last modified on | 2023/03/15 20:57:40 |
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Basic information
Public title
Impact of left ventricular stiffness by diastolic wall strain on atrial high rate episodes after pacemaker implantation
Acronym
LEADER study
Scientific Title
Impact of left ventricular stiffness by diastolic wall strain on atrial high rate episodes after pacemaker implantation
Scientific Title:Acronym
LEADER study
Region
| Japan |
Condition
Condition
Patients scheduled for pacemaker implantation without a history of atrial fibrillation
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Elucidating predictors of patients with asymptomatic atrial fibrillation and initial atrial fibrillation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
One year atrial tachycardia episode after pacemaker implantation
Key secondary outcomes
(Before implanting a pacemaker)
Clinical data: age, gender, medical history, arrhythmia type, comorbid heart disease, past history, medications, height, weight, NYHA classification,
Blood sampling: Cre, Hb, UA, BNP, proBNP, Troponin-T
ECG: heart rate, QRS wave form, presence or absence of leg block,
Trans thoracic echocardiography:
Left atrial diameter, left atrial volume, left ventricular wall thickness, LV mass index, left ventricular end diastolic diameter, left ventricular systolic diameter, left ventricular ejection fraction, E wave, deceleration time, E / e` ratio, diastolic wall strain
(Pacemaker implantation technique)
Pacemaker type, setting, lead position (right atrial appendage, right ventricular apex, other)
(After pacemaker implantation)
Atrial hypertachycardia episode (atrial rate of 180 / min or more lasting for 6 minutes or more) at 1 month, 3 months, and 6 months after pacemaker visit.
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 scheduled for pacemaker implantation without a history of atrial fibrillation
Key exclusion criteria
Excludes patients with organic heart disease (cardiomyopathy, history of myocardial infarction, severe valvular disease), cardiac surgery, hemodialysis, and pacing-dependent.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takanao |
| Middle name | |
| Last name | Mine |
Organization
Hyogo College of Medicine
Division name
Department of Cardiovascular and Renal Medicine
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya, Japan
TEL
81-798-45-6553
mine@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Takanao |
| Middle name | |
| Last name | Mine |
Organization
Hyogo College of Medicine
Division name
Department of Cardiovascular and Renal Medicine
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya, Japan
TEL
81-798-45-6553
Homepage URL
mine@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
no data
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kobe Ekisaikai Hosptal
Kawasaki Hospital
Meiwa Hospital
Hoshigaola Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Review Board of Hyogo College of Medicine
Address
1-1 Mukogawa-cho, Nishinomiya, Japan
Tel
0798-45-6066
rinri@hyo-med.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
兵庫医科大学病院（兵庫県）、神戸掖済会病院（兵庫県）、川崎病院（兵庫県）、明和病院（兵庫県）、JCHO 星ヶ丘医療センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | Month | 12 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 03 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Approved by Ethics Review Committee
Management information
Registered date
| 2020 | Year | 03 | Month | 12 | Day |
Last modified on
| 2023 | 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=R000045016
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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