Involvement of FFA Metabolism and Insulin Resistance in Cardiac Death

Coronary Artery Disease Clinical Trial

— CD_HD_FAIR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01068080
• Other study ID #: Toujinkai Clincal Study-2
• Status: Completed
• Phase: N/A
• First received: February 11, 2010
• Last updated: February 11, 2010
• Start date: January 2001
• Est. completion date: December 2004

Study information

• Verified date: October 2000
• Source: Toujinkai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Education, Culture, Sports, Science and Technology
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 90 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Hemodialysis
• Insulin Resistance
• Kidney Disease
• Kidney Diseases
• Myocardial Ischemia

Locations

Country	Name	City	State
Japan	Toujinkai Hospital	Kyoto

Sponsors (1)

Lead Sponsor	Collaborator
Toujinkai Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac death			No
Secondary	All-cause death			No