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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008283
Receipt No. R000009633
Scientific Title Impact of Clinical Parameters Including Endothelial Dysfunction on Procedure-related and Contrast-induced Renal Damage (PCRD) in Patients with Underwent Coronary Angiography
Date of disclosure of the study information 2012/07/01
Last modified on 2017/09/20

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Basic information
Public title Impact of Clinical Parameters Including Endothelial Dysfunction on Procedure-related and Contrast-induced Renal Damage (PCRD) in Patients with Underwent Coronary Angiography
Acronym Impact of Clinical Parameters Including Endothelial Dysfunction on Procedure-related and Contrast-induced Renal Damage (PCRD) in Patients with Underwent Coronary Angiography
Scientific Title Impact of Clinical Parameters Including Endothelial Dysfunction on Procedure-related and Contrast-induced Renal Damage (PCRD) in Patients with Underwent Coronary Angiography
Scientific Title:Acronym Impact of Clinical Parameters Including Endothelial Dysfunction on Procedure-related and Contrast-induced Renal Damage (PCRD) in Patients with Underwent Coronary Angiography
Region
Japan

Condition
Condition stable patients with angina-like chest pain who were referred and scheduled for cardiac catheterization
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine clinical parameters including endothelial dysfunction would have an effect on the occurrence of PCRD
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes We defined the occurrence of PCRD as any increase in serum creatinine measured before and after the procedures
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 patients with angina-like chest pain who were referred and scheduled for cardiac catheterization including coronary angiography and coronary intervention
Key exclusion criteria Patients with acute coronary syndrome who requires emergent coronary procedure, established CKD [estimated glomerular filtration rate (eGFR) <60ml/min/1.75m2], other contrast exposure within one week or less from the index procedure, symptomatic heart failure [left ventricular ejection fraction < 50% and/or plasma B-type natriuretic peptide (BNP) level >200pg/ml], collagen disease, neuromuscular disease, and malignant disease
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seigo Sugiyama
Organization Graduate School of Medical Sciences, Kumamoto University
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-1 Honjo, Kumamoto City 860-8556, Japan
TEL 81-96-373-5175
Email ssugiyam@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hitoshi Sumida
Organization Graduate School of Medical Sciences, Kumamoto University
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-1 Honjo, Kumamoto City 860-8556, Japan
TEL 81-96-373-5175
Homepage URL
Email ssugiyam@kumamoto-u.ac.jp

Sponsor
Institute Graduate School of Medical Sciences, Kumamoto University
Institute
Department

Funding Source
Organization Scientific Research (No. C19590869 for S. Sugiyama) from the Ministry of Education, Science, and Culture in Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 熊本大学附属病院

Other administrative information
Date of disclosure of the study information
2012 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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
2006 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 08 Month 01 Day
Last follow-up date
2011 Year 04 Month 01 Day
Date of closure to data entry
2011 Year 04 Month 01 Day
Date trial data considered complete
2011 Year 04 Month 01 Day
Date analysis concluded
2012 Year 07 Month 01 Day

Other
Other related information Patients who developed PCRD exhibited significant impairment of peripheral endothelial function. The underlying endothelial dysfunction might play an important role in pathogenesis of PCRD.

Management information
Registered date
2012 Year 06 Month 27 Day
Last modified on
2017 Year 09 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009633

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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