UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027872 |
|---|---|
| Receipt number | R000029070 |
| Scientific Title | Evaluation of safety, success rate, and clinical impact of percutaneous coronary intervention without contrast medium (PCIWOC): A prospective cohort study |
| Date of disclosure of the study information | 2017/06/22 |
| Last modified on | 2020/07/16 22:44:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of safety, success rate, and clinical impact of percutaneous coronary intervention without contrast medium (PCIWOC): A prospective cohort study
Acronym
The clinical significance of PCI without contrast medium
Scientific Title
Evaluation of safety, success rate, and clinical impact of percutaneous coronary intervention without contrast medium (PCIWOC): A prospective cohort study
Scientific Title:Acronym
The clinical significance of PCI without contrast medium
Region
| Japan |
Condition
Condition
Angina pectoris and acute coronary syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To survey safety, key factors in successful procedure, prognostic impact of IVUS- or OCT-guided PCI without contrast medium (PCIWOC)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of contrast medium induced acute kidney injury
Key secondary outcomes
1-year renal function; 1-year MACCE; 1-year mortality; composite of 1-year cardiac death, non-fatal myocardial infarction, heart failure and renal failure
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients without dialysis who are to undergo PCI
Key exclusion criteria
PCI for chronic total occlusion
Patients with dialysis
Patients who plan to undergo directional coronary atherectomy
Patients who are not expected to survive >1 year due to non-cardiac diseases such as malignancy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Higuchi |
Organization
Kyorin University Hospital
Division name
Department of Cardiology
Zip code
181-8611
Address
6-20-2, Shinkawa, Mitaka City, Tokyo
TEL
0422-47-5511
satoshi_hgc@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Higuchi |
Organization
Kyorin University Hospital
Division name
Department of Cardiology
Zip code
181-8611
Address
6-20-2, Shinkawa, Mitaka City, Tokyo
TEL
0422-47-5511
Homepage URL
satoshi_hgc@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
the Ethics Committee of Kyorin University Hospital
Address
6-20-2, Shinkawa, Mitaka-City, Tokyo
Tel
0422-47-5511
irb@ks.kyorin-u.ac.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
杏林大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/abs/10.1002/ccd.28958
Number of participants that the trial has enrolled
81
Results
This study included 106 lesions from 81 patients. Successful noncontrast PCI was performed in 95 (90%) lesions. Contrast-induced acute kidney injury (CI-AKI) was observed in 4 (5%). Six-month worsening renal function (WRF) was observed in 18 individuals (22%). While successful noncontrast PCI was not associated with the incidence of CI-AKI, successful noncontrast PCI was inversely associated with WRF (hazard ratio, 0.28; 95% confidence interval, 0.09-0.90) after adjustment for renal function.
Results date posted
| 2020 | Year | 06 | Month | 23 | Day |
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
| 2016 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The present study is designed as prospective cohort to evaluate success rate and the clinical impact of PCI without contrast medium.
Management information
Registered date
| 2017 | Year | 06 | Month | 22 | Day |
Last modified on
| 2020 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029070
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
