SarcoidosisNCT00958087
Cardiac Sarcoidosis and FDG-PET
An observational study of Sarcoidosis and Dilated Cardiomyopathy, run by Kurume University at 1 site in Japan.
Trial summary
Sarcoidosis is a multi-systemic inflammatory disorder of unknown cause characterized by the formation of non-caseating granulomas in involved organs. Its cardiac involvement may be potentially fatal. Read more about this study
- Who is it for?
- Ages 35 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcoidosis, Dilated Cardiomyopathy
- How many people
- 20 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2004to Jul 2010
- 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 35 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Fasting FDG-PET will be performed in patients with sarcoidosis and age-matched DCM patients. Among them, systemic sarcoidosis will be diagnosed clinically and/or histologically, and referred for cardiac sarcoidosis. Patients with sarcoidosis will reveal cardiac involvement based on guidelines established in 2006 by the Japanese Ministry of Health and Welfare. Healthy control subjects will undergo FDG-PET.
Who may be able to join
- Subjects between the ages of 35 and 85 years
- Subjects with systemic sarcoidosis
- Subjects with idiopathic sarcoidosis
Who cannot join
- Subjects with active inflammatory diseases not related to sarcoidosis
- Subjects with coronary artery disease and primary valvular heart diseases
- Subjects with uncontrolled diabetes mellitus or insulin treatment
- Subjects with use of the corticosteroid
- Subjects with systemic disorders such as active inflammatory, liver, renal, hematopoietic, and malignant disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 18F-fluorodeoxyglucose Positron Emission Tomography Imaging in Cardiac Sarcoidosis Reveals Characteristic Heterogeneity of Tracer Uptake and the Disease Activity in Myocardium
Sarcoidosis is a multi-systemic inflammatory disorder of unknown cause characterized by the formation of non-caseating granulomas in involved organs. Its cardiac involvement may be potentially fatal. Although endomyocardial biopsy is required for definitive diagnosis of cardiac sarcoidosis, it is invasive and lacks sensitivity. The specific diagnostic tool for cardiac sarcoidosis is far from satisfactory. Recent studies have revealed that FDG-PET with under fasting conditions is a useful method for identification of cardiac sarcoidosis patients. However, to our knowledge, no investigations have been published with regard to FDG quantification for the diagnosis and management of cardiac sarcoidosis by PET.
Read the detailed description
Fasting FDG-PET will be performed in all subjects. Serum calcium, C-reactive protein (CRP), angiotensin converting enzyme (ACE), lysozyme, and B-type natriuretic peptide (BNP) levels will be measured in all patients. All patients will undergo chest X-ray, resting 12-lead ECG, transthoracic echocardiography, and 3 types of radionucleotide imaging using Tc-99m sestamibi for myocardial perfusion, Ga and FDG for whole-body evaluation. All assessments will be conducted within 2 weeks and no sign indicated any change in disease activity of sarcoidosis. The patients with cardiac involvement will be treated with 30 mg/day of prednisolone orally for the first 4 weeks, then will decrease to a dose of 20 mg/day for the next 4 weeks, and will maintain to a dose of 10 mg/day afterwards.
- Conditions
- Sarcoidosis, Dilated Cardiomyopathy
- Medical subject headings
- Sarcoidosis, Cardiomyopathy, Dilated
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 |
|---|---|---|
| Sarcoidosis with cardiac involvement | Not described | |
| Dilated cardiomyopathy | Not described | |
| Sarcoidosis without cardiac involvement | Not described | |
| Healthy controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usefulness of Fasting FDG-PET for Diagnosis and Management of Cardiac Sarcoidosis
Measured: Baseline and at 1, 3, 6, 12 months after the initial FDG-PET
Secondary outcomes (4)
Change from baseline in circulating markers of inflammatory and sarcoidosis
Measured: Baseline and at 1, 3, 6, 12 months after the initial FDG-PET
Change from baseline in plasma dendritic cells
Measured: Baseline and at 1, 3, 6, 12 months after the initial FDG-PET
Change from baseline in plasma BNP, AGE, RAGE, and PEDF levels
Measured: Baseline and at 1, 3, 6, 12 months after the initial FDG-PET
All cardiovascular events and all cause death for 5 years
Measured: Baseline and at 1, 3, 6, 12 months after the initial FDG-PET
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2009 (estimated)
- Study startMar 2004
- Primary completionMar 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcoidosisStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kurume University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nobuhiro Tahara, Kurume University
- Investigators
- Nobuhiro Tahara, MD, PhD, Principal investigator, Kurume University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00958087
- Sponsor's protocol ID
- CS-PET
- Status last verified
- Jul 2010
- First submitted
- 12 Aug 2009
- Last updated
- 27 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-fluorodeoxyglucose Positron Emission Tomography Imaging in Cardiac Sarcoidosis Reveals Characteristic Heterogeneity of Tracer Uptake and the Disease Activity in Myocardium
- ClinicalTrials.gov ID
- NCT00958087
- Acronym / sponsor ID
- CS-PET
- Conditions
- Sarcoidosis, Dilated Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Kurume UniversityUniversity, hospital or other
- Study start
- Mar 2004
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 13 Aug 2009 (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.
Sarcoidosis is a multi-systemic inflammatory disorder of unknown cause characterized by the formation of non-caseating granulomas in involved organs. Its cardiac involvement may be potentially fatal. Although endomyocardial biopsy is required for definitive diagnosis of cardiac sarcoidosis, it is invasive and lacks sensitivity. The specific diagnostic tool for cardiac sarcoidosis is far from satisfactory. Recent studies have revealed that FDG-PET with under fasting conditions is a useful method for identification of cardiac sarcoidosis patients. However, to our knowledge, no investigations have been published with regard to FDG quantification for the diagnosis and management of cardiac sarcoidosis by PET.
Detailed description
Fasting FDG-PET will be performed in all subjects. Serum calcium, C-reactive protein (CRP), angiotensin converting enzyme (ACE), lysozyme, and B-type natriuretic peptide (BNP) levels will be measured in all patients. All patients will undergo chest X-ray, resting 12-lead ECG, transthoracic echocardiography, and 3 types of radionucleotide imaging using Tc-99m sestamibi for myocardial perfusion, Ga and FDG for whole-body evaluation. All assessments will be conducted within 2 weeks and no sign indicated any change in disease activity of sarcoidosis. The patients with cardiac involvement will be treated with 30 mg/day of prednisolone orally for the first 4 weeks, then will decrease to a dose of 20 mg/day for the next 4 weeks, and will maintain to a dose of 10 mg/day afterwards.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sarcoidosis with cardiac involvement | – | – |
| Dilated cardiomyopathy | – | – |
| Sarcoidosis without cardiac involvement | – | – |
| Healthy controls | – | – |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Fasting FDG-PET will be performed in patients with sarcoidosis and age-matched DCM patients. Among them, systemic sarcoidosis will be diagnosed clinically and/or histologically, and referred for cardiac sarcoidosis. Patients with sarcoidosis will reveal cardiac involvement based on guidelines established in 2006 by the Japanese Ministry of Health and Welfare. Healthy control subjects will undergo FDG-PET.
Key inclusion criteria (3 listed)
- Subjects between the ages of 35 and 85 years
- Subjects with systemic sarcoidosis
- Subjects with idiopathic sarcoidosis
Key exclusion criteria (5 listed)
- Subjects with active inflammatory diseases not related to sarcoidosis
- Subjects with coronary artery disease and primary valvular heart diseases
- Subjects with uncontrolled diabetes mellitus or insulin treatment
- Subjects with use of the corticosteroid
- Subjects with systemic disorders such as active inflammatory, liver, renal, hematopoietic, and malignant disease
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
Usefulness of Fasting FDG-PET for Diagnosis and Management of Cardiac Sarcoidosis
Time frame: Baseline and at 1, 3, 6, 12 months after the initial FDG-PET
4 secondary outcomes
Change from baseline in circulating markers of inflammatory and sarcoidosis
Time frame: Baseline and at 1, 3, 6, 12 months after the initial FDG-PET
Change from baseline in plasma dendritic cells
Time frame: Baseline and at 1, 3, 6, 12 months after the initial FDG-PET
Change from baseline in plasma BNP, AGE, RAGE, and PEDF levels
Time frame: Baseline and at 1, 3, 6, 12 months after the initial FDG-PET
All cardiovascular events and all cause death for 5 years
Time frame: Baseline and at 1, 3, 6, 12 months after the initial FDG-PET
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 27 Sep 2012.
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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.
Nobuhiro Tahara, MD, PhD principal investigator
Kurume University
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 Sarcoidosis and Dilated Cardiomyopathy, run by Kurume University 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 3 inclusion and 5 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 27 Sep 2012. 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?
Usefulness of Fasting FDG-PET for Diagnosis and Management of Cardiac Sarcoidosis (time frame: Baseline and at 1, 3, 6, 12 months after the initial FDG-PET). It is what the study was designed to measure, not a finding.
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 27 Sep 2012.