UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004625 |
|---|---|
| Receipt number | R000005508 |
| Scientific Title | Multicenter study on strain rate versus myocardial velocity for assessment of left ventricular relaxation and filling pressure (SMAP study) |
| Date of disclosure of the study information | 2010/12/01 |
| Last modified on | 2014/05/27 14:32:21 |
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Basic information
Public title
Multicenter study on strain rate versus myocardial velocity for assessment of left ventricular relaxation and filling pressure (SMAP study)
Acronym
Strain rate versus myocardial velocity for assessment of left ventricular relaxation and filling pressure (SMAP study)
Scientific Title
Multicenter study on strain rate versus myocardial velocity for assessment of left ventricular relaxation and filling pressure (SMAP study)
Scientific Title:Acronym
Strain rate versus myocardial velocity for assessment of left ventricular relaxation and filling pressure (SMAP study)
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate whether myocardial strain rate indices can more accurately estimate left ventricular relaxation and filling pressure than myocardial velocity indices.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate the correlations between myocardial velocity index (e'), flow propagation velocity (Vp), strain rate index (ESR) and time constant (tau) or LV filling pressure.
Key secondary outcomes
To compare the accuracy for estimating LV relaxation and filling pressure between the measuring methods of e', Vp, and ESR.
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 with angina pectoris, suspected angina pectoris, or prior myocardial infarction, patients with dilated or hypertrophic cardiomyopathy, and patients with hypertension who is developing heart failure. Patients with adequate echocardiographic image quality.
Key exclusion criteria
Patients with heart rhythm other than sinus rhythm, patients with relevant left-sided valvular heart disease, patients after mitral or aortic valve replacement or mitral annular plasty, or patients with receiving hemodialysis.
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Tsutsui |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
Kita-15, Nishi-7, Kita-ku, Sapporo 060-8638, Japan
TEL
011-706-6974
htsutsui@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Yamada |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
Kita-15, Nishi-7, Kita-ku, Sapporo 060-8638, Japan
TEL
011-706-6974
Homepage URL
syamada@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Japan Society of Ultrasonics in Medicine
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
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
北海道大学病院（北海道）、筑波大学附属病院（茨城県）、名古屋市立大学病院（愛知県）、名古屋市総合リハビリテーションセンター（愛知県）、三重大学医学部付属病院（三重県）、徳島大学病院（徳島県）、山口大学医学部附属病院（山口県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
0bservation
Management information
Registered date
| 2010 | Year | 11 | Month | 26 | Day |
Last modified on
| 2014 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005508
