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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00586950
Acronym
B-SAFE
Enrollment
1000
Registered
2008-01-07
Start date
2006-06-30
Completion date
2011-09-30
Last updated
2011-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Myocardial Free Fatty Acid metabolism, High risk patients, End-stage renal failure, Cardiovascular events, prognosis

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.

Interventions

None listed

Sponsors

Toho University Ohashi Medical Center
CollaboratorUNKNOWN
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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.

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026