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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00586950
First Posted: January 7, 2008
Last Update Posted: September 13, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Toho University Ohashi Medical Center
Information provided by:
Translational Research Informatics Center, Kobe, Hyogo, Japan
  Purpose
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.

Condition
Coronary Disease Fatty Acids, Unsaturated Radioisotopes Hemodialysis Single Photon Emission Computed Tomography

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Outcome Study on BMIPP SPECT Analysis for Decreasing Cardiac Events in Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:

Estimated Enrollment: 1000
Study Start Date: June 2006
Study Completion Date: September 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Defined Population
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00586950


Locations
Japan
Toho University Ohashi Medical Center
Meguro-ku, Tokyo, Japan, 135-8515
Sponsors and Collaborators
Translational Research Informatics Center, Kobe, Hyogo, Japan
Toho University Ohashi Medical Center
Investigators
Principal Investigator: Kenjiro Kikuchi, MD, PhD Asahikawa Medical College
  More Information

Responsible Party: Kenjiro Kikuchi, MD, PhD , Principal Investigator, Hokkaido Cardiovascular Hospital
ClinicalTrials.gov Identifier: NCT00586950     History of Changes
Other Study ID Numbers: UHA_CAD05-01
First Submitted: December 21, 2007
First Posted: January 7, 2008
Last Update Posted: September 13, 2011
Last Verified: February 2009

Keywords provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:
Myocardial Free Fatty Acid metabolism
High risk patients
End-stage renal failure
Cardiovascular events
prognosis

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases