UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013090 |
|---|---|
| Receipt number | R000015258 |
| Scientific Title | Actual Conditions and Prognosis of Coronary Artery Disease Patients with Implantable Defibrillator Therapy in Japan -Japan Implantable Devices in Coronary Artery Disease Study |
| Date of disclosure of the study information | 2014/10/01 |
| Last modified on | 2019/08/15 10:26:17 |
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Basic information
Public title
Actual Conditions and Prognosis of Coronary Artery Disease Patients with Implantable Defibrillator Therapy in Japan -Japan Implantable Devices in Coronary Artery Disease Study
Acronym
Japan Implantable Devices in Coronary Artery Disease Study (JID-CAD)
Scientific Title
Actual Conditions and Prognosis of Coronary Artery Disease Patients with Implantable Defibrillator Therapy in Japan -Japan Implantable Devices in Coronary Artery Disease Study
Scientific Title:Acronym
Japan Implantable Devices in Coronary Artery Disease Study (JID-CAD)
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The investigation of actual conditions, including therapy for coronary artery disease and ventricular tachyarrhythmia, in coronary artery disease patients with implantable defibrillator therapy in Japan.
Basic objectives2
Others
Basic objectives -Others
Investigation of actual therapy and prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Actual conditions of appropriate therapy within 2 years after ICD/CRT-D implantation
2. Actual conditions of sustained ventricular tachycardia/fibrillation within 2 years after CRT-P implantation
Key secondary outcomes
1.Actual conditions of inappropriate therapy
2.Prognosis including death, cause of death, admission of hospital for heart failure, and unexpected admission of hospital
3.Cardiovascular events
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients with coronary artery disease
2.Patients are 20 years and more, regardless sex
3.Patients implanted ICD/CRT-D/CRT-P in according to guidelines for non-pharmacotherapy of cardiac arrhythmias (JCS 2011)
Key exclusion criteria
1.Patients Less than 20 years old
2.Patients does not desire to apply the trial
3.Patients in whom Doctor judges the difficulty of applying the trial.
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Okumura |
Organization
Hirosaki University School of Medicine
Division name
Department of Cardiology, Pulmonology and Nephrology
Zip code
036-8563
Address
53 Motomachi,Hirosaki, Aomori,
TEL
0172-39-5057
ninaika@cc.hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Akihiko |
| Middle name | |
| Last name | Shimizu |
Organization
Yamaguchi Graduate School of Medicine
Division name
Faculty of Health Sciences
Zip code
755-8505
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi Japan 755-8505
TEL
0836-22-2856
Homepage URL
ashimizu@yamaguchi-u.ac.jp
Sponsor or person
Institute
Japanese Heart Rhythm Society
Institute
Department
Personal name
Funding Source
Organization
Japanese Heart Rhythm Scoiety
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Ymaguchi Universssity Hospital
Address
+81-836*22-2428
Tel
0836-22-2428
me223@yamaguchi-u.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
山口大学附属病院(山口県)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
401
Results
The number of cases was 401, age 68+/-10 years, LVEF was 35+/-13%.
Appropriate shock was 20% for 2 years. Shock after 2 years was equivalent to primary prevention. During follow-up, 14 cases of ablation and 34 cases of revascularization were performed. Mortality after ablation was slightly less. The mortality in patients with revascularization was 0%.
Mortality was 10% in 1.5 years. The prognosis of the primary prevention group was poor, and it was thought to be due to age and severe heart failure.
Results date posted
| 2019 | Year | 08 | Month | 15 | Day |
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
Completed
Date of protocol fixation
| 2014 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2019 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 22 | Day |
Other
Other related information
The results of observation is wheter the defibrilaltion therapy occurre, or not
Management information
Registered date
| 2014 | Year | 02 | Month | 06 | Day |
Last modified on
| 2019 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015258
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| Registered date | File name |
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