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123I-BMIPP SPECT Analysis for Decreasing Cardiac Events in Hemodialysis Patients (B-SAFE)

This study is ongoing, but not recruiting participants.
Information provided by Translational Research Informatics Center, Kobe, Hyogo, Japan

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Descriptive Information Fields
Brief Title  123I-BMIPP SPECT Analysis for Decreasing Cardiac Events in Hemodialysis Patients
Official Title  Outcome Study on BMIPP SPECT Analysis for Decreasing Cardiac Events in Hemodialysis Patients
Brief Summary

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.

Detailed Description
Study Phase
Study Type  Observational
Study Design  Cohort, Prospective
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Coronary Disease
Fatty Acids, Unsaturated
Radioisotopes
Hemodialysis
Single Photon Emission Computed Tomography
Intervention 
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  1000
Start Date  June 2006
Completion Date July 2010
Eligibility Criteria 

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.
Gender Both
Ages 20 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  Japan
Administrative Information Fields
NCT ID  NCT00586950
Organization ID UHA_CAD05-01
Secondary IDs ††
Study Sponsor  Translational Research Informatics Center, Kobe, Hyogo, Japan
Collaborators †† Toho University Ohashi Medical Center
Investigators 
Principal Investigator:     Kenjiro Kikuchi, MD, PhD     Asahikawa Medical College    
Information Provided By Translational Research Informatics Center, Kobe, Hyogo, Japan
Verification Date December 2007
First Received Date  December 21, 2007
Last Updated Date December 21, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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