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

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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	Translational Research Informatics Center, Kobe, Hyogo, Japan Toho University Ohashi Medical Center
Information provided by:	Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier:	NCT00586950

Purpose

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.

Condition

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

Genetics Home Reference related topics:

Heart Diseases Vascular Diseases

MedlinePlus related topics:

Heart Diseases Vascular Diseases

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

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

Further study details as provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	1000
Study Start Date:	June 2006
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Defined Population

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00586950

Locations


Japan, Tokyo
	Toho University Ohashi Medical Center
	Meguro-ku, Tokyo, Japan, 135-8515

Sponsors and Collaborators

Translational Research Informatics Center, Kobe, Hyogo, Japan

Toho University Ohashi Medical Center

Investigators


Principal Investigator:	Kenjiro Kikuchi, MD, PhD	Asahikawa Medical College

More Information

Responsible Party:	Hokkaido Cardiovascular Hospital ( Kenjiro Kikuchi, MD, PhD , Principal Investigator )
Study ID Numbers:	UHA_CAD05-01
First Received:	December 21, 2007
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00586950
Health Authority:	Japan: Ministry of Education, Culture, Sports, Science and Technology