Involvement of FFA Metabolism and Insulin Resistance in Cardiac Death (CD_HD_FAIR)

February 11, 2010 updated by: Toujinkai Hospital

Prediction of Impaired Myocardial Fatty Acid Metabolism and Insulin Resistance for Cardiac Death of Hemodialysis Patients With Normal Coronary Arteries

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

Study Overview

Status

Completed

Conditions

Detailed Description

Dialysis patients have extraordinarily high mortality rates. Cardiac diseases play an important role in deaths among end-stage renal disease (ESRD) patients undergoing renal replacement therapy. Previous studies have shown that maintenance hemodialysis patients have high prevalence of obstructive coronary artery disease. While obstructive coronary artery disease is undoubtedly involved in cardiac deaths induced by acute myocardial infarction or congestive heart failure and in sudden cardiac death, cardiac death can occur in hemodialysis patients who have apparently no pre-existing obstructive coronary artery disease. However, few studies have investigated the factors which are useful for stratifying the risk of cardiac death in dialysis patients with normal coronary arteries.

We recently showed that visualizing severely impaired myocardial fatty acid metabolism on images can help not only to detect obstructive coronary artery disease [8], but also to identify patients at high risk of cardiac death among hemodialysis patients without coronary intervention or old myocardial infarction and among those with coronary revascularization by percutaneous coronary artery intervention. In addition, combination of impaired cardiac fatty acid metabolism with insulin resistance, which is one of the risk factors related with coronary atherosclerosis, may contribute to left ventricular dysfunction in patients with maintenance hemodialysis with normal coronary arteries. Impaired myocardial fatty acid metabolism and insulin resistance, both of which reduce the synthesis of myocardial adenosine triphosphate (ATP), are likely to be involved in fatal cardiac events by causing deficiency of myocardial energy supply. In this study, we prospectively investigated the potential of myocardial fatty acid metabolism and insulin resistance to predict cardiac death in hemodialysis patients without pre-existing obstructive coronary artery disease.

Study Type

Observational

Enrollment (Actual)

155

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kyoto, Japan, 612-8026
        • Toujinkai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Cardiac death

Secondary Outcome Measures

Outcome Measure
All-cause death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Toujinkai Hospital

Investigators

  • Study Director: Toshihiko Ono, MD, Toujinkai Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

February 11, 2010

First Submitted That Met QC Criteria

February 11, 2010

First Posted (Estimate)

February 12, 2010

Study Record Updates

Last Update Posted (Estimate)

February 12, 2010

Last Update Submitted That Met QC Criteria

February 11, 2010

Last Verified

October 1, 2000

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Toujinkai Clincal Study-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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