UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008283
Receipt number 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 10:42:30

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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 or person

Institute

Graduate School of Medical Sciences, Kumamoto University

Institute

Department

Personal name



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

Value
https://center6.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