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

This study has been completed.
Sponsor:
Collaborator:
Toho University Ohashi Medical Center
Information provided by:
Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier:
NCT00586950
First received: December 21, 2007
Last updated: September 12, 2011
Last verified: February 2009
History of Changes
  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:

U.S. FDA Resources

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 21, 2007
Last Updated: September 12, 2011
Health Authority: Japan: Ministry of Education, Culture, Sports, Science and Technology

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

ClinicalTrials.gov processed this record on May 16, 2013