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

This study has been completed.
Sponsor:
Information provided by:
Toujinkai Hospital
ClinicalTrials.gov Identifier:
NCT01068080
First received: February 11, 2010
Last updated: NA
Last verified: October 2000
History: No changes posted
  Purpose

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


Condition
Kidney Disease
Coronary Artery Disease
Hemodialysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prediction of Impaired Myocardial Fatty Acid Metabolism and Insulin Resistance for Cardiac Death of Hemodialysis Patients With Normal Coronary Arteries

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Toujinkai Hospital:

Primary Outcome Measures:
  • Cardiac death [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All-cause death [ Designated as safety issue: No ]

Enrollment: 155
Study Start Date: January 2001
Study Completion Date: December 2004
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01068080

Locations
Japan
Toujinkai Hospital
Kyoto, Japan, 612-8026
Sponsors and Collaborators
Toujinkai Hospital
Investigators
Study Director: Toshihiko Ono, MD Toujinkai Group
  More Information

No publications provided

Responsible Party: Masato Nishimura, MD, PhD, Toujinkai Hospital
ClinicalTrials.gov Identifier: NCT01068080     History of Changes
Other Study ID Numbers: Toujinkai Clincal Study-2
Study First Received: February 11, 2010
Last Updated: February 11, 2010
Health Authority: Japan: Ministry of Education, Culture, Sports, Science and Technology

Keywords provided by Toujinkai Hospital:
fatty acid metabolism
insulin resistance
cardiac death
 hemodialysis
normal coronary arteries
Predictive values of impaired myocardial fatty acid metabolism or insulin resistance for cardiac death of hemodialysis patients with normal coronary arteries

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Insulin Resistance
Kidney Diseases
Death
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
 Vascular Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Urologic Diseases
Pathologic Processes
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013