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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031700
Receipt No. R000035988
Scientific Title Intervention study on determination of optimal AV / VV Delay in patients implanted with CRT using electrocardiogram
Date of disclosure of the study information 2018/03/13
Last modified on 2018/03/13

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Basic information
Public title Intervention study on determination of optimal AV / VV Delay in patients implanted with CRT using electrocardiogram
Acronym New Ishikawa's CRT Method study
(NICM study)
Scientific Title Intervention study on determination of optimal AV / VV Delay in patients implanted with CRT using electrocardiogram
Scientific Title:Acronym New Ishikawa's CRT Method study
(NICM study)
Region
Japan

Condition
Condition heart failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To enable easy setting of AV / VV Delay which takes approximate value of optimal AV Delay determined using echocardiography while suppressing right ventricular pacing in CRT
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes BNP
EF(Modified Simpson)
LVDs
LVDd
LAD
Time taken to set AV/VV delay
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Measure PQ interval at A Sense
When the 150 msPQ interval is less than 150 ms, the PQ interval is -40 ms, the LV preceding 30 ms
When the PQ interval is 150 ms to 200 ms, the PQ interval is -50 ms, the LV preceding 30 ms
When the PQ interval is 200 ms or more, set PQ interval 120 ms, LV-RV simultaneous pacing.

This study is a crossover study for 3 months, after 3 months we change the setting from 1 group to 2 groups and finish in 6 months.
Interventions/Control_2 Set AV delay by cardiac ultrasound examination and set VV delay to 0 ms.
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 participating in this study must meet all the criteria shown below.
1.Patients meeting the criteria for CRT / CRTD implantation according to guidelines of the Japanes Circulation Society.
2. Patients who have implanted or implanted CRT system.
3.Patients who are able to visit regular follow-up according to protocol.
4 Patient who received explanation about this study and agreed.
Key exclusion criteria Patients eligible for at least one of the following exclusion criteria can not participate in this study.

1. Patients whose predicted life expectancy is less than 1 year
2. Patients who may undergo heart transplant surgery within one year
3. Patients with persistent atrial fibrillation
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiyuki Ishikawa
Organization yokohama city university hospital
Division name Department of Cardiology
Zip code
Address 3-9 Fukuura, kanazawa-ku, YOkohmama 236-0004 Japan
TEL 045-787-2800
Email tishika@med.yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tabito Kino
Organization yokohama city university hospital
Division name Department of Cardiology
Zip code
Address 3-9 Fukuura, kanazawa-ku, YOkohmama 236-0004 Japan
TEL 045-787-2800
Homepage URL
Email kino-tabito@umin.ac.jp

Sponsor
Institute Department of Cardiology, Yokohama City University Hospital
Institute
Department

Funding Source
Organization N/A
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
Address
Tel
Email

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
2018 Year 03 Month 13 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
2017 Year 03 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 13 Day
Last modified on
2018 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035988

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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