UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000008922
Receipt No. 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 (Ver. 7)

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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
Last 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
Email ikari@is.icc.u-tokai.ac.jp

Public contact
1st 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
Email f.saito@tokai-u.jp

Sponsor
Institute Tokai University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010461