Coronary DiseaseB-SAFENCT00586950
123I-BMIPP SPECT Analysis for Decreasing Cardiac Events in Hemodialysis Patients
An observational study of Coronary Disease and Fatty Acids, Unsaturated, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.
Trial summary
The aim of this multi-center study is to determine the applicability of BMIPP to diagnosing cardiac disease and to predicting the outcome of patients on hemodialysis. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Disease, Fatty Acids, Unsaturated, Radioisotopes
- How many people
- 1,000 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2006to Sep 2011
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Defined Population
Inclusion Criteria:Adult hemodialysis patients with one or more of the following 10 risk factors for coronary heart disease
- Hypertension
- Diabetes mellitus
- Hyperlipidemia
- Obliterative arteriosclerosis in the lower extremities
- Smoker
- Family history of juvenile coronary artery disease
- History of ischemic stroke
- History of heart failure requiring hospitalization
- Within 3 months after initiation of hemodialysis therapy
- Dialysis hypotension
Exclusion Criteria:Hemodialysis patients who meet any one of the following conditions will be excluded.
- Peritoneal dialysis
- Severe valvular disorder requiring treatment
- Diagnosis of hypertrophic cardiomyopathy(HCM) or dilated cardiomyopathy(DCM) before start of dialysis
- History of revascularization(PCI, CABG) or prior diagnosis of myocardial infarction
- Hypersensitivity to BMIPP or its analogue
- Judged unsuitable for the study for any other reasons by physicians.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcome Study on BMIPP SPECT Analysis for Decreasing Cardiac Events in Hemodialysis Patients
The aim of this multi-center study is to determine the applicability of BMIPP to diagnosing cardiac disease and to predicting the outcome of patients on hemodialysis.
- Conditions
- Coronary Disease, Fatty Acids, Unsaturated, Radioisotopes, Hemodialysis, Single Photon Emission Computed Tomography
- Keywords
- Myocardial Free Fatty Acid metabolism, High risk patients, End-stage renal failure, Cardiovascular events, prognosis
- Medical subject headings
- Coronary Disease, Kidney Failure, Chronic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2008 (estimated)
- Study startJun 2006
- Primary completionNov 2010
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Sponsor type
- University, hospital or other
- Collaborators
- Toho University Ohashi Medical Center
- Investigators
- Kenjiro Kikuchi, MD, PhD, Principal investigator, Asahikawa Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00586950
- Sponsor's protocol ID
- UHA_CAD05-01
- Acronym
- B-SAFE
- Status last verified
- Feb 2009
- First submitted
- 21 Dec 2007
- Last updated
- 13 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Study on BMIPP SPECT Analysis for Decreasing Cardiac Events in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT00586950
- Acronym / sponsor ID
- B-SAFE / UHA_CAD05-01
- Conditions
- Coronary Disease, Fatty Acids, Unsaturated, Radioisotopes, Hemodialysis, Single Photon Emission Computed Tomography
- Keywords
- Myocardial Free Fatty Acid metabolism, High risk patients, End-stage renal failure, Cardiovascular events, prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, JapanUniversity, hospital or other
- Collaborators
- Toho University Ohashi Medical Center
- Study start
- Jun 2006
- Primary completion
- Nov 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 7 Jan 2008 (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 aim of this multi-center study is to determine the applicability of BMIPP to diagnosing cardiac disease and to predicting the outcome of patients on hemodialysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Defined Population
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
Not reported in the source record.
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 13 Sep 2011.
Related trials for Coronary Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
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.
Kenjiro Kikuchi, MD, PhD principal investigator
Asahikawa Medical College
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 Coronary Disease and Fatty Acids, Unsaturated, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan 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?
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 13 Sep 2011. 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.
Where can I read the original study information?
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 13 Sep 2011.