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

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

Status: Completed

Conditions: Fatty Acids, Unsaturated; Hemodialysis; Single Photon Emission Computed Tomography; Radioisotopes; Coronary Disease

Study type: Observational

Funder types: Other

Identifiers

NCT00586950

UHA_CAD05-01

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.