NCT01068080

Brief Summary

The investigators evaluated predictive values of myocardial fatty acid metabolism and insulin resistance for cardiac death of hemodialysis patients with normal coronary arteries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
155

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2001

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

January 1, 2001

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2010

Completed
Last Updated

February 12, 2010

Status Verified

October 1, 2000

First QC Date

February 11, 2010

Last Update Submit

February 11, 2010

Conditions

Keywords

fatty acid metabolisminsulin resistancecardiac deathhemodialysisnormal coronary arteriesPredictive values of impaired myocardial fatty acid metabolism or insulin resistance for cardiac death of hemodialysis patients with normal coronary arteries

Outcome Measures

Primary Outcomes (1)

  • Cardiac death

Secondary Outcomes (1)

  • All-cause death

Study Arms (1)

Myocardial fatty acid metabolism, Insulin resistance

Myocardial fatty acid metabolism was evaluated by myocardial fatty acid imaging using BMIPP SPECT. Insulin resistance was evaluated by HOMA-IR.

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hemodialysis patients who had normal coronary arteries identified by coronary angiography and underwent the examination of BMIPP SPECT and measurement of HOMA-IR as a parameter of insulin resistance.

You may qualify if:

  • Hemodialysis patients who had normal coronary arteries identified by coronary angiography and underwent the examination of BMIPP SPECT and measurement of HOMA-IR as a parameter of insulin resistance.

You may not qualify if:

  • Patients who had not done BMIPP SPECT within one month of coronary angiography
  • Congestive heart failure (NYHA 3-4)
  • Significant valvular heart disease
  • Pacemaker
  • Idiopathic cardiomyopathy
  • Malignancy
  • Patients who had not measured HOMA-IR within one month after coronary angiography
  • Patients receiving extrinsic insulin or medication of sulfonylurea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toujinkai Hospital

Kyoto, Kyoto, 612-8026, Japan

Location

Related Publications (1)

  • Nishimura M, Okamoto Y, Takatani T, Sato N, Nishida M, Hashimoto T, Yamazaki S, Kobayashi H, Ono T. Improvement of myocardial fatty acid metabolism by oral nicorandil in hemodialysis patients without coronary artery disease. J Nephrol. 2015 Apr;28(2):227-34. doi: 10.1007/s40620-014-0125-5. Epub 2014 Jul 29.

MeSH Terms

Conditions

Kidney DiseasesCoronary Artery DiseaseInsulin ResistanceDeath

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Toshihiko Ono, MD

    Toujinkai Group

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

February 11, 2010

First Posted

February 12, 2010

Study Start

January 1, 2001

Study Completion

December 1, 2004

Last Updated

February 12, 2010

Record last verified: 2000-10

Locations