UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008922 |
|---|---|
| Receipt number | R000010461 |
| Scientific Title | Extreme reduction of contrast dose with intravascular ultrasound guide PCI for patients with chronic kidney disease |
| Date of disclosure of the study information | 2012/09/14 |
| Last modified on | 2019/03/21 17:07:38 |
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Basic information
Public title
Extreme reduction of contrast dose with intravascular ultrasound guide PCI for patients with chronic kidney disease
Acronym
MINICON 2
Scientific Title
Extreme reduction of contrast dose with intravascular ultrasound guide PCI for patients with chronic kidney disease
Scientific Title:Acronym
MINICON 2
Region
| Japan |
Condition
Condition
coronary artery disease requiring coronary intervention in patients with chronic kidney disease
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify minimum contrast (minicon) PCI in patients with chronic kidney disease. Minicon PCI is defined as PCI using extreme low contrast dose less than estimated glomerular filtration (ml)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
All cause mortality and maitenance dialysis induction rate at 1 year
Key secondary outcomes
*Achievement rate of minicon PCI
*Rate of contrast induced nephropathy defined as increase of Cr >0.5 or 25%.
*Mortality rate at 1 year
*Induction rate of maintenance dialysis at 1 year
* Stroke rate at 1 year
* Myocardial infarction rate at 1 year
* repeat PCI at 1 year
* bypass surgery at 1 year
* Major adverse cardiac events (cardiac death, myocardial infarction, PCI or CABG)
* Major adverse cardiac and cereblar events (all cause mortality, myocardial infarction, stroke and all revascularization)
* Major adverse cardiac, cereblar and renal events (all cause mortality, myocardial infarction, stroke and indcution of dialysis)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Percutaneous coronary intervention (PCI)
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
* coronary artery disease requiring PCI
* elective case
* chronic kidney disease with estimated glomerular filtration rate (eGFR) less than 30 or eGFR between 30 and 45 with proteinuria (urine protein / Cr > 0.015 or urine microalbumin / Cr >30)
Key exclusion criteria
* Maintenance dialysis is started before PCI
* Insufficient renal protection with saline or bicarbonate transfusion
* plan of schedule surgery
* renal transplantation
* no indication of PCI
* Others
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Ikari |
Organization
Tokai University
Division name
Department of Cardiology
Zip code
259-1193
Address
143 Shimokasuya, Isehara, 259-1193, Japan
TEL
0463-93-1121
ikari@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | Fumie |
| Middle name | |
| Last name | Saito |
Organization
Tokai University
Division name
Department of Cardiology
Zip code
259-1193
Address
143 Shimokasuya, Isehara
TEL
0463-93-1121
Homepage URL
f.saito@tokai-u.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Funding Source
Organization
Daiichi Sankyo
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokai University
Address
143 Shimokasuya, Isehara, Kanagawa
Tel
0463-93-1121
tokai-rinsho@ml.tokai-u.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
| 2012 | Year | 09 | Month | 14 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s12928-018-0552-7
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s12928-018-0552-7
Number of participants that the trial has enrolled
184
Results
Conclusions. The IVUS-guided MINICON PCI reduces CI-AKI significantly and induction of RRT at 1 year in patients with stage 4 or 5 advanced CKD.
Results date posted
| 2019 | Year | 03 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Average age 76 years old, 79% were male and diabetes was 61%. the rate of stage 4 and 5 CKD exhibited no statistically significant difference.
Participant flow
Prospective registration
Adverse events
The histogram in Fig. 1 shows the distribution of the contrast volume, which in the IVUS-guided MINICON PCI group was significantly less compared with the angiography-guided standard PCI group (22 +/- 20 vs. 130 +/- 105 mL; P = 0.001). All patients in the IVUS-guided MINICON PCI group attempted to attain the contrast volume less than the eGFR value (achievement rate, 78%). Furthermore, CI-AKI was observed in standard angiography-guided or IVUS-guided MINICON PCI groups as 15% and 2%, respectively (P = 0.001; Fig. 2).
Outcome measures
The primary endpoint of this study was a composite endpoint of all-cause mortality, myocardial infarction and induction of RRT at 1 year following PCI. Moreover, the secondary endpoints were contrast dose, the incidence of CI-AKI after PCI, or cardiac death, stroke, myocardial infarction and any additional coronary revascularization, including PCI or coronary artery bypass graft, at 1 year.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2012 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2012 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 14 | Day |
Last modified on
| 2019 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010461
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