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NCT00586950 Clinical Trial

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

Coronary Disease Clinical Trial

— B-SAFE  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00586950
Other study ID # UHA_CAD05-01
Secondary ID
Status Completed
Phase N/A
First received December 21, 2007
Last updated September 12, 2011
Start date June 2006
Est. completion date September 2011

Study information
Verified date February 2009
Source Translational Research Informatics Center, Kobe, Hyogo, Japan
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Education, Culture, Sports, Science and Technology
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1000
Est. completion date September 2011
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Japan Toho University Ohashi Medical Center Meguro-ku Tokyo

Sponsors (2)
Lead Sponsor Collaborator
Translational Research Informatics Center, Kobe, Hyogo, Japan Toho University Ohashi Medical Center

Country where clinical trial is conducted

Japan, 

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