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.

First Received: December 21, 2007 Last Updated: February 9, 2009 History of Changes

Sponsor:	Translational Research Informatics Center, Kobe, Hyogo, Japan
Collaborator:	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

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Outcome Study on BMIPP SPECT Analysis for Decreasing Cardiac Events in Hemodialysis Patients

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Dialysis Kidney Failure

U.S. FDA Resources

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:	November 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

No publications provided

Responsible Party:	Hokkaido Cardiovascular Hospital ( Kenjiro Kikuchi, MD, PhD , Principal Investigator )
Study ID Numbers:	UHA_CAD05-01
Study First Received:	December 21, 2007
Last Updated:	February 9, 2009
ClinicalTrials.gov Identifier:	NCT00586950 History of Changes
Health Authority:	Japan: Ministry of Education, Culture, Sports, Science and Technology

Keywords provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:

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

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on November 30, 2009