UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011920 |
|---|---|
| Receipt number | R000013880 |
| Scientific Title | Association between blood pressure variability assessed by ambulatory blood pressure monitoring and tissue characterization of coronary plaques |
| Date of disclosure of the study information | 2013/10/01 |
| Last modified on | 2017/02/27 22:26:40 |
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Basic information
Public title
Association between blood pressure variability assessed by ambulatory blood pressure monitoring and tissue characterization of coronary plaques
Acronym
Association between blood pressure variability assessed by ambulatory blood pressure monitoring and tissue characterization of coronary plaques
Scientific Title
Association between blood pressure variability assessed by ambulatory blood pressure monitoring and tissue characterization of coronary plaques
Scientific Title:Acronym
Association between blood pressure variability assessed by ambulatory blood pressure monitoring and tissue characterization of coronary plaques
Region
| Japan |
Condition
Condition
Acute coronary syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association between blood pressure variability by ambulatory blood pressure monitoring and coronary plaque burden or plaque vulnerability in acute coronary syndrome patients.
Basic objectives2
Others
Basic objectives -Others
Analysis of the relationship above
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between blood pressure variability by ABPM and coronary plaque burden or plaque vulnerability by IVUS or IB-IVUS
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Acute coronary syndrome patients who underwent primary percutaneous coronary intervention with using IVUS
Key exclusion criteria
1.Patients with unstable vital signs
2.Patients with intravenous inotropic agents
3.Patients with mechanical assist device
4.Patients assessed by principal investigator as ineligible
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshio Kobayashi |
Organization
Chiba University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL
043-222-7171
tsuchiya-chiba@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichi Saito |
Organization
Chiba University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL
043-222-7171
Homepage URL
y-saito@chiba-u.jp
Sponsor or person
Institute
Chiba University School of Medicine Department of Cardiovascular Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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 | 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
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
| 2013 | Year | 08 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective study
Management information
Registered date
| 2013 | Year | 09 | Month | 30 | Day |
Last modified on
| 2017 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013880
