UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004320 |
|---|---|
| Receipt number | R000005174 |
| Scientific Title | Effect of Intensive Blood Pressure Control on Progression of Coronary Atherosclerosis: Randomized Evaluation by Intravascular Ultrasound |
| Date of disclosure of the study information | 2010/10/04 |
| Last modified on | 2012/09/27 16:20:45 |
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Basic information
Public title
Effect of Intensive Blood Pressure Control on Progression of Coronary Atherosclerosis: Randomized Evaluation by Intravascular Ultrasound
Acronym
Effect of Intensive Blood Pressure Control on Progression of Coronary Atherosclerosis: Randomized Evaluation by Intravascular Ultrasound
Scientific Title
Effect of Intensive Blood Pressure Control on Progression of Coronary Atherosclerosis: Randomized Evaluation by Intravascular Ultrasound
Scientific Title:Acronym
Effect of Intensive Blood Pressure Control on Progression of Coronary Atherosclerosis: Randomized Evaluation by Intravascular Ultrasound
Region
| Japan |
Condition
Condition
Hypertension, Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of intensive blood pressure control on progression of atherosclerosis by intravascular ultrasound.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of percent atheroma volume evaluated by intravascular ultrasound after 18 months.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
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
| Medicine |
Interventions/Control_1
Intensive blood pressure control (SBP<120mmHg)
Interventions/Control_2
Standard blood pressure control (SBP<140mmHg)
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients who are planning to take CAG or PCI.
2)Patients with primary hypertention: SBP140-180mmHg within one month.
3)20<=Age<80
Key exclusion criteria
1)Patients with severe hypertention.
2)Patients with secondary hypertension.
3)Patients treated hypertention with more than 3 drugs.
4)Patients with coronary artery disease in left main trank.
5)Patients with moderate heart failure.
6)Patients with severe valvelar disease.
7)Patients with liver dysfunction.
8)Patients with renal dysfuction(Cr>=2.0 mg/dL).
9)Pregnant or nursing woman.
10)Patients with uncontrollable arrythmia.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Kimura |
Organization
Kyoto University
Division name
Cardiovascular Medicine
Zip code
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyoto University
Division name
Cardiovascular Meicine
Zip code
Address
TEL
0757514255
Homepage URL
Sponsor or person
Institute
Cardiovascular Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Research Institute for Production Development
Organization
Division
Category of Funding Organization
Non profit foundation
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 | 10 | Month | 04 | 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
| 2010 | Year | 09 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | 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
Management information
Registered date
| 2010 | Year | 10 | Month | 04 | Day |
Last modified on
| 2012 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005174
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
