- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00586950
123I-BMIPP SPECT Analysis for Decreasing Cardiac Events in Hemodialysis Patients (B-SAFE)
September 12, 2011 updated by: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Outcome Study on BMIPP SPECT Analysis for Decreasing Cardiac Events in Hemodialysis Patients
The aim of this multi-center study is to determine the applicability of BMIPP to diagnosing cardiac disease and to predicting the outcome of patients on hemodialysis.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Anticipated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Tokyo
-
Meguro-ku, Tokyo, Japan, 135-8515
- Toho University Ohashi Medical Center
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Defined Population
Description
Inclusion Criteria:Adult hemodialysis patients with one or more of the following 10 risk factors for coronary heart disease
- Hypertension
- Diabetes mellitus
- Hyperlipidemia
- Obliterative arteriosclerosis in the lower extremities
- Smoker
- Family history of juvenile coronary artery disease
- History of ischemic stroke
- History of heart failure requiring hospitalization
- Within 3 months after initiation of hemodialysis therapy
- Dialysis hypotension
Exclusion Criteria:Hemodialysis patients who meet any one of the following conditions will be excluded.
- Peritoneal dialysis
- Severe valvular disorder requiring treatment
- Diagnosis of hypertrophic cardiomyopathy(HCM) or dilated cardiomyopathy(DCM) before start of dialysis
- History of revascularization(PCI, CABG) or prior diagnosis of myocardial infarction
- Hypersensitivity to BMIPP or its analogue
- Judged unsuitable for the study for any other reasons by physicians.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Kenjiro Kikuchi, MD, PhD, Asahikawa Medical College
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2006
Primary Completion (Actual)
November 1, 2010
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
December 21, 2007
First Submitted That Met QC Criteria
December 21, 2007
First Posted (Estimate)
January 7, 2008
Study Record Updates
Last Update Posted (Estimate)
September 13, 2011
Last Update Submitted That Met QC Criteria
September 12, 2011
Last Verified
February 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UHA_CAD05-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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