UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029283 |
|---|---|
| Receipt number | R000033471 |
| Scientific Title | Evaluation on blood biomarkers related with outcomes in patients with stable anigina pectoris undergoing percutaneous coronary intervention |
| Date of disclosure of the study information | 2017/09/25 |
| Last modified on | 2017/09/25 19:06:05 |
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Basic information
Public title
Evaluation on blood biomarkers related with outcomes in patients with stable anigina pectoris undergoing percutaneous coronary intervention
Acronym
Evaluation on blood biomarkers related with outcomes in patients with stable anigina pectoris undergoing percutaneous coronary intervention
Scientific Title
Evaluation on blood biomarkers related with outcomes in patients with stable anigina pectoris undergoing percutaneous coronary intervention
Scientific Title:Acronym
Evaluation on blood biomarkers related with outcomes in patients with stable anigina pectoris undergoing percutaneous coronary intervention
Region
| Japan |
Condition
Condition
patients with stable angina undergoing percutaneous coronary intervention
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate blood biomarkers related with outcomes in patients with stable angina undergoing percutaneous coronary intervention
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, revascularization, and hospitalization for heart failure.
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
stable angina pectoris undergoing their first percutaneous coronary intervention
Key exclusion criteria
1.New York Heart Association functional classification of >III
2.malignant disease with an expected prognosis of <1 year
3.chronic inflammatory disease
4.chronic renal failure (serum creatinine concentration of >2.0mg/dl)
5. Patinets who did not provide written informed consent
Target sample size
144
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Miyoshi |
Organization
Okayama University Hospital
Division name
Cardiovascular Medicine
Zip code
Address
2-5-1, Shikata-cho, Kita-ku, Okayama
TEL
086-235-7351
miyoshit@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toru Miyoshi |
Organization
Okayama University Hospital
Division name
Cardiovascular Medicine
Zip code
Address
2-5-1 Shikada-cho Kita-ku Okayama
TEL
086-235-7351
Homepage URL
miyoshit@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Okayama University
Organization
Division
Category of Funding Organization
Government offices of other countries
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
香川県立中央病院、岡山大学病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 25 | 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
| 2008 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 08 | 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
Obsevatonal study
Management information
Registered date
| 2017 | Year | 09 | Month | 25 | Day |
Last modified on
| 2017 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033471
