UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041784 |
|---|---|
| Receipt number | R000047607 |
| Scientific Title | The investigation of cardiovascular prognosis and vascular reaction after directional coronary atherectomy followed by drug-coated balloon angioplasty |
| Date of disclosure of the study information | 2020/09/14 |
| Last modified on | 2020/12/13 09:34:22 |
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Basic information
Public title
The investigation of optimal cardiovascular treatment with directional coronary atherectomy
Acronym
OPT-DCA
Scientific Title
The investigation of cardiovascular prognosis and vascular reaction after directional coronary atherectomy followed by drug-coated balloon angioplasty
Scientific Title:Acronym
OPT-DCA
Region
| Japan |
Condition
Condition
Coronary atherosclerosis
Angina pectoris, Acute coronary syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1) To assess cardiovascular prognosis in patients who underwent PCI with DCA.
2) To evaluate effects of the treatment combined DCA with DCB.
Basic objectives2
Others
Basic objectives -Others
The investigation of the independent predictor of cardiovascular events after PCI combined DCA and DCB.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Composite endpoint; Cardiac death, non-fatal myocardial infarction, Revascularization for target lesion or vessel failure.
2) The difference between DCA+DCB therapy and DCA alone therapy.
Key secondary outcomes
The assessment for risk factor of adverse prognosis in DCA+DCB therapy.
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
1) Patients more than 20 years old, at the timing of percutaneous coronary intervention (PCI).
2) Patients who was performed PCI with directional coronary atherectomy.
Key exclusion criteria
1) Patients with any malignancy or inflammatory diseases (such as rheumatoid and connective tissue disease)
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Yamamoto |
Organization
Hyogo Brain and Heart Center
Division name
The division of Cardiovascular medicine
Zip code
670-0981
Address
520, Saisho-Kou
TEL
+81792933131
y0493589m@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Yamamoto |
Organization
Hyogo Brain and Heart Center
Division name
The division of Cardiovascular medicine
Zip code
670-0981
Address
520, Saisho-Kou, Himeji, Japan
TEL
+81792933131
Homepage URL
y0493589m@hotmail.co.jp
Sponsor or person
Institute
Hyogo Brain and Heart Center
Institute
Department
Personal name
Funding Source
Organization
Hyogo Brain and Heart Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo Brain and Heart Centor
Address
520, Saisyo-Kou, Himeji, Hyogo, Japan
Tel
0792933131
y0493589m@hotmail.co.jp
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
| 2020 | Year | 09 | Month | 14 | 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
| 2020 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing.
Management information
Registered date
| 2020 | Year | 09 | Month | 14 | Day |
Last modified on
| 2020 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047607
