123I-BMIPP SPECT Analysis for Decreasing Cardiac Events i... | NCT00586950

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

NCT00586950

Sponsor

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

Status

Completed

Last Update Posted

Sep 13, 2011Estimated

Enrollment

1,000Estimated

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

Nov 2010Actual

Completion Date

Sep 2011Actual

First Submitted Date

Dec 21, 2007

First Submission Date that Met QC Criteria

Dec 21, 2007

First Posted Date

Jan 7, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2011

Last Update Posted Date

Sep 13, 2011Estimated

Name	Class
Toho University Ohashi Medical Center	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Defined Population

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kenjiro Kikuchi, MD, PhD	Asahikawa Medical College	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Toho University Ohashi Medical Center		Meguro-ku	Tokyo	135-8515	Japan

Condition Browse Module

MeSH Terms

ID	Term
D003327	Coronary Disease
D007676	Kidney Failure, Chronic

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided