UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009669 |
|---|---|
| Receipt number | R000011285 |
| Scientific Title | Effect of cardiac resynchronization therapy on phasic coronary flow pattern and microvascular resistance in patients with non-ischemic cardiomyopathy |
| Date of disclosure of the study information | 2013/01/01 |
| Last modified on | 2012/12/30 15:36:59 |
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Basic information
Public title
Effect of cardiac resynchronization therapy on phasic coronary flow pattern and microvascular resistance in patients with non-ischemic cardiomyopathy
Acronym
Effect of cardiac resynchronization therapy on coronary flow
Scientific Title
Effect of cardiac resynchronization therapy on phasic coronary flow pattern and microvascular resistance in patients with non-ischemic cardiomyopathy
Scientific Title:Acronym
Effect of cardiac resynchronization therapy on coronary flow
Region
| Japan |
Condition
Condition
Non-ischemic cardiomyopathy
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the aim of this study was to investigate the effect of CRT on the phasic coronary flow pattern and microvascular resistance of left anterior descending coronary artery and left circumflex coronary artery in patients with non-ischemic cardiomyopathy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Average peak velocity, phasic coronary flow parameters, coronary flow reserve, hyperemic microvascular resistance index
Key secondary outcomes
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
The indications for CRT were severe HF (New York Heart Association [NYHA] functional class III or IV) despite optimal medical therapy, left ventricular ejection fraction (LVEF) ≤ 35%, and QRS duration ≥ 130 milliseconds (ms). Patients were included in this study, that met the following criteria: (1) non-ischemic cardiomyopathy assessed by coronary angiography, (2) sinus rhythm, (3) complete left bundle branch block (LBBB) or complete atrioventricular block (CAVB) , (4) implantation of first CRT device, including upgrade
Key exclusion criteria
Ischemic cardiomyopathy, decompensated HF, and significant renal dysfunction (serum creatinine ≥ 2.0mg/dL) at 1week after CRT
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiro Shinke |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-5846
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Cardiovascular Medicine
Zip code
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
Homepage URL
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Cardiovascular Medicine, Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
| 2013 | Year | 01 | Month | 01 | 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
| 2009 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
22 consecutive patients were enrolled in this study and recruitmentof study participants was ongoing.
Management information
Registered date
| 2012 | Year | 12 | Month | 30 | Day |
Last modified on
| 2012 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011285
