123I-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.

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Key information

Conditions

Coronary Disease Cardiovascular Diseases Chronic Disease Disease Attributes Fatty Acids, Unsaturated Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Hemodialysis Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Radioisotopes Renal Insufficiency Renal Insufficiency, Chronic Single Photon Emission Computed Tomography Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Toho University Ohashi Medical Center

Meguro-ku, Tokyo, 135-8515, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Sponsors and collaborators

Lead sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Other

Collaborators

Toho University Ohashi Medical Center

Registry information

Official study title

Outcome Study on BMIPP SPECT Analysis for Decreasing Cardiac Events in Hemodialysis Patients

Acronym: B-SAFE

Important dates

Study start: 2006
Primary completion: 2010
Study completion: 2011
First posted: Jan 7, 2008
Registry last updated: Sep 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed