NCT00586950

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 7, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

September 13, 2011

Status Verified

February 1, 2009

Enrollment Period

4.4 years

First QC Date

December 21, 2007

Last Update Submit

September 12, 2011

Conditions

Coronary DiseaseFatty Acids, UnsaturatedRadioisotopesHemodialysisSingle Photon Emission Computed Tomography

Keywords

Myocardial Free Fatty Acid metabolismHigh risk patientsEnd-stage renal failureCardiovascular eventsprognosis

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Defined Population

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toho University Ohashi Medical Center

Meguro-ku, Tokyo, 135-8515, Japan

Location

MeSH Terms

Conditions

Coronary DiseaseKidney Failure, Chronic

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kenjiro Kikuchi, MD, PhD

    Asahikawa Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 7, 2008

Study Start

June 1, 2006

Primary Completion

November 1, 2010

Study Completion

September 1, 2011

Last Updated

September 13, 2011

Record last verified: 2009-02

Locations

JP(1)