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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000039790 |
Receipt No. | 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 | 2020/09/13 |
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 |
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Condition | |||
Condition | Patients scheduled for pacemaker implantation without a history of atrial fibrillation | ||
Classification by specialty |
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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 | |
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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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 | |
Institute | Hyogo College of Medicine |
Institute | |
Department |
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 |
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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 | |
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Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
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Anticipated trial start date |
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Last follow-up date |
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Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | Approved by Ethics Review Committee |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045016 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |