123I-BMIPP SPECT Analysis for Decreasing Cardiac Events in Hemodialysis Patients - Tabular View

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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

This Tabular View shows the required WHO registration data elements as marked by ^†

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

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.