Kidney DiseaseCD_HD_FAIRNCT01068080
Involvement of FFA Metabolism and Insulin Resistance in Cardiac Death
An observational study of Kidney Disease and Coronary Artery Disease, run by Toujinkai Hospital at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Kidney Disease, Coronary Artery Disease, Hemodialysis
- How many people
- 155 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2001to Dec 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Kidney Disease, Coronary Artery Disease, Hemodialysis
- Keywords
- 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
- Medical subject headings
- Kidney Diseases, Coronary Artery Disease, Insulin Resistance, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Cardiac death
Secondary outcomes (1)
All-cause death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2010 (estimated)
- Study startJan 2001
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toujinkai Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Toshihiko Ono, MD, Study director, Toujinkai Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01068080
- Sponsor's protocol ID
- Toujinkai Clincal Study-2
- Acronym
- CD_HD_FAIR
- Status last verified
- Oct 2000
- First submitted
- 11 Feb 2010
- Last updated
- 12 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25070153
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Impaired Myocardial Fatty Acid Metabolism and Insulin Resistance for Cardiac Death of Hemodialysis Patients With Normal Coronary Arteries
- ClinicalTrials.gov ID
- NCT01068080
- Acronym / sponsor ID
- CD_HD_FAIR / Toujinkai Clincal Study-2
- Conditions
- Kidney Disease, Coronary Artery Disease, Hemodialysis
- Keywords
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Toujinkai HospitalUniversity, hospital or other
- Study start
- Jan 2001
- Study completion
- Dec 2004 (actual)
- First posted
- 12 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators evaluated predictive values of myocardial fatty acid metabolism and insulin resistance for cardiac death of hemodialysis patients with normal coronary arteries.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiac death
1 secondary outcome
All-cause death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2010.
- Derived from this study: PubMed 25070153Nishimura 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toshihiko Ono, MD study director
Toujinkai Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Disease and Coronary Artery Disease, run by Toujinkai Hospital at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac death. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01068080, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2010.