UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003596 |
|---|---|
| Receipt number | R000004077 |
| Scientific Title | Combined Assessment of Left Ventricular Dyssynchrony and Contractility for Predicting Response to Cardiac Resynchronization Therapy: Multicenter Evaluation of i-Index |
| Date of disclosure of the study information | 2010/05/11 |
| Last modified on | 2012/02/20 15:02:39 |
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Basic information
Public title
Combined Assessment of Left Ventricular Dyssynchrony and Contractility for Predicting Response to Cardiac Resynchronization Therapy:
Multicenter Evaluation of i-Index
Acronym
MEIDEX
Scientific Title
Combined Assessment of Left Ventricular Dyssynchrony and Contractility for Predicting Response to Cardiac Resynchronization Therapy:
Multicenter Evaluation of i-Index
Scientific Title:Acronym
MEIDEX
Region
| Japan |
Condition
Condition
Heart Failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the ability of an echocardiographic index called i-index for improving patient selection of cardic resynchronization therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Relative reduction of left ventricular end-systolic volume of more than 15% at 6 months following initiation of cardic resynchronization therapy.
Key secondary outcomes
Clinical composite score
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
Patients who are scheduled to undergo cardiac resynchronization therapy and filfull all of the following:
1.QRS duration>/=120ms
2.LVEF</=35%
3.NYHA class III or IV
4.Recieving appropreate medical therapy for heart failure including ACE-inhibitor or ARB and beta-blocke, unless contraindicated
4.Sinus rhythm or Right ventricular pacing (%ventricular pacing>90%)
Key exclusion criteria
1. Inability to obtain informed consent
2. Age less than 20
3. Disqualification by attending physician
4. Incapable of follow-uo visits
5. Irregular ventricular response due to atrial arrhythmia
6. Intravenous inotropic drug therapy
7. unstable angina/acute myocardial infarction
8. Cardiac surgery including CABG and PCI within 3 months
9. CRT with more than or equal to three sites ventricular pacing
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuya Inden |
Organization
Department of Cardiology, Nagoya University Graduate School of Medicine
Division name
Department of Cardiology
Zip code
Address
65 Tsurumaicho, Showaku, Nagoya, Japan
TEL
052-741-2150
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromi Asano |
Organization
Medtronic Japan
Division name
CRDM Nagoya Branch
Zip code
Address
9F 2-9-15 Sakae, Naka-Ku, Nagoya, Japan
TEL
052-220-6446
Homepage URL
Sponsor or person
Institute
Medtronic Japan
Institute
Department
Personal name
Funding Source
Organization
Medtronic Japan
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2010 | Year | 05 | Month | 11 | 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
Completed
Date of protocol fixation
| 2010 | Year | 03 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 02 | Month | 01 | Day |
Other
Other related information
Observational study
Management information
Registered date
| 2010 | Year | 05 | Month | 11 | Day |
Last modified on
| 2012 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004077
