Inflammatory CardiomyopathyNCT03356756
PET MRI Study in Patients With Cardiac Sarcoidosis
An observational study of Inflammatory Cardiomyopathy and Sarcoidosis, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Myocarditis or inflammatory cardiomyopathy refers to inflammation of the heart muscle (the myocardium). Sarcoidosis is a multisystem granulomatous disorder that may involve the heart, causing inflammation, and potentially resulting in complications including arrhythmia and sudden death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Cardiomyopathy, Sarcoidosis
- What is being tested?
- simultaneous combined 18F-FDG PET and cardiac MRI imaging
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 27 Jun 2016to 23 Feb 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients 18 years or older with known or suspected cardiac sarcoidosis or other inflammatory cardiomyopathy who are referred for clinically indicated 18F-FDG PET/CT imaging at University Health Network.
Who may be able to join
- The primary criterion for enrolment will be patients ≥18 years of age with known or suspected sarcoidosis or other inflammatory cardiomyopathy who are referred for clinically indicated 18F-FDG PET/CT imaging
Who cannot join
- Standard cardiac MRI contraindications include arrhythmia, claustrophobia, history of allergic reaction or other contraindication to gadolinium-based contrast agent, impaired renal function with eGFR < 60 ml/min/1.73m2, pregnancy, breast-feeding, or any other general contraindication to MRI (pacemaker, cerebral aneurysm clips, shrapnel, etc).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic and Prognostic Significance of Combined PET/MRI in Inflammatory Cardiomyopathies and Sarcoidosis
Myocarditis or inflammatory cardiomyopathy refers to inflammation of the heart muscle (the myocardium). Sarcoidosis is a multisystem granulomatous disorder that may involve the heart, causing inflammation, and potentially resulting in complications including arrhythmia and sudden death. The objective of this study is to evaluate the diagnostic and prognostic significance of simultaneous combined 18F-FDG PET and cardiac MRI imaging in the evaluation of inflammatory cardiomyopathies including cardiac sarcoidosis. Combined PET/MRI imaging may allow for detection and quantification of active myocardial inflammation as well as chronic fibrosis and scarring. Results of this study may allow for earlier detection of cardiac inflammation when compared with methods in current clinical use, and may lead to better understanding of the disease processes contributing to adverse outcomes. Elucidation of imaging findings associated with future adverse event risk may impact patient management such as providing an indication for pacemaker or defibrillator implantation, or escalation of medical therapy.
Read the detailed description
Myocarditis or inflammatory cardiomyopathy refers to inflammation of the myocardium. Sarcoidosis is a multisystem granulomatous disorder of unknown etiology, which can result in myocardial inflammation. Approximately 5% of patients with sarcoidosis have clinically apparent cardiac involvement, yet autopsy series indicate that cardiac involvement is present in up to 25% of cases. This discrepancy suggests that cardiac sarcoidosis may be under-diagnosed in clinical practice. Recent studies have demonstrated high diagnostic accuracy of both cardiac MRI and 18F-labelled fluoro-2-deoxyglucose (FDG) PET for detection of cardiac involvement. However, cardiac MRI may fail to identify areas of active inflammation even with fluid sensitive T2-weighted sequences.
Fasting 18F-FDG positron emission tomography (PET) has been shown to identify early cardiac sarcoidosis with relatively high sensitivity. To date, simultaneous PET/MRI evaluation of cardiac inflammation and sarcoidosis has only been described in limited case reports. The objective of the proposed research is to evaluate the utility of simultaneous PET/MRI imaging in patients with cardiac sarcoidosis and other inflammatory cardiomyopathies.
- Conditions
- Inflammatory Cardiomyopathy, Sarcoidosis
- Being tested
- simultaneous combined 18F-FDG PET and cardiac MRI imaging
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simultaneous combined 18F-FDG PET and cardiac MRI imagingDiagnostic test
Patients will undergo a research study performed with an integrated whole-body PET/MRI imaging system designed for simultaneous PET and MRI acquisition, immediately after standard of care PET/CT exam.
| Study group | Role | What they receive |
|---|---|---|
| PET MRI exam | simultaneous combined 18F-FDG PET and cardiac MRI imaging (PET MRI) performed immediately after the PET CT exam. Receives: Diagnostic Test: simultaneous combined 18F-FDG PET and cardiac MRI imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incremental value of combined 18F-FDG PET and cardiac MRI imaging in the evaluation of patients with suspected cardiac sarcoidosis or cardiac inflammation
Patients will undergo standard clinical evaluation using modified consensus guidelines for the diagnosis of sarcoidosis. Following enrolment, patients will also undergo parallel assessment for cardiac involvement by PET/MRI. Comparison of cardiac involvement identified by modified consensus criteria and PET/MRI will be performed.
Measured: Completion of enrollment, an average of two years
Secondary outcomes (2)
The differences in circulating plasma biomarkers between cardiac with suspected cardiac sarcoidosis and healthy people
A cohort of 25 healthy volunteers will be recruited for comparison of patients with suspected cardiac sarcoidosis. Biomarkers such as microRNA will be analyzed in both groups.
Measured: Completion of enrollment, an average of two years
The prognostic significance of PET-MRI imaging findings in patients with cardiac inflammation
Clinical follow-up to track adverse events to validate imaging findings and determine their prognostic significance.
Measured: Through study completion, an average of three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start27 Jun 2016
- Primary completion23 Feb 2024
- Study completion23 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inflammatory CardiomyopathyStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kate Hanneman, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03356756
- Sponsor's protocol ID
- 15-9933
- Status last verified
- May 2024
- First submitted
- 3 Nov 2017
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cheung E, Ahmad S, Aitken M, Chan R, Iwanochko RM, Balter M, Metser U, Veit-Haibach P, Billia F, Moayedi Y, Ross HJ, Hanneman K. Combined simultaneous FDG-PET/MRI with T1 and T2 mapping as an imaging biomarker for the diagnosis and prognosis of suspected cardiac sarcoidosis. Eur J Hybrid Imaging. 2021 Dec 16;5(1):24. doi: 10.1186/s41824-021-00119-w.
PubMed 34913098Marschner CA, Aloufi F, Aitken M, Cheung E, Thavendiranathan P, Iwanochko RM, Balter M, Moayedi Y, Duero Posada J, Hanneman K. Combined FDG PET/MRI versus Standard-of-Care Imaging in the Evaluation of Cardiac Sarcoidosis. Radiol Cardiothorac Imaging. 2023 Sep 28;5(5):e220292. doi: 10.1148/ryct.220292. eCollection 2023 Oct.
PubMed 38076597
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Prognostic Significance of Combined PET/MRI in Inflammatory Cardiomyopathies and Sarcoidosis
- ClinicalTrials.gov ID
- NCT03356756
- Acronym / sponsor ID
- 15-9933
- Conditions
- Inflammatory Cardiomyopathy, Sarcoidosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 27 Jun 2016 (actual)
- Primary completion
- 23 Feb 2024 (actual)
- Study completion
- 23 Feb 2024 (actual)
- First posted
- 29 Nov 2017 (actual)
- 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.
Myocarditis or inflammatory cardiomyopathy refers to inflammation of the heart muscle (the myocardium). Sarcoidosis is a multisystem granulomatous disorder that may involve the heart, causing inflammation, and potentially resulting in complications including arrhythmia and sudden death. The objective of this study is to evaluate the diagnostic and prognostic significance of simultaneous combined 18F-FDG PET and cardiac MRI imaging in the evaluation of inflammatory cardiomyopathies including cardiac sarcoidosis. Combined PET/MRI imaging may allow for detection and quantification of active myocardial inflammation as well as chronic fibrosis and scarring. Results of this study may allow for earlier detection of cardiac inflammation when compared with methods in current clinical use, and may lead to better understanding of the disease processes contributing to adverse outcomes. Elucidation of imaging findings associated with future adverse event risk may impact patient management such as providing an indication for pacemaker or defibrillator implantation, or escalation of medical therapy.
Detailed description
Myocarditis or inflammatory cardiomyopathy refers to inflammation of the myocardium. Sarcoidosis is a multisystem granulomatous disorder of unknown etiology, which can result in myocardial inflammation. Approximately 5% of patients with sarcoidosis have clinically apparent cardiac involvement, yet autopsy series indicate that cardiac involvement is present in up to 25% of cases. This discrepancy suggests that cardiac sarcoidosis may be under-diagnosed in clinical practice. Recent studies have demonstrated high diagnostic accuracy of both cardiac MRI and 18F-labelled fluoro-2-deoxyglucose (FDG) PET for detection of cardiac involvement. However, cardiac MRI may fail to identify areas of active inflammation even with fluid sensitive T2-weighted sequences.
Fasting 18F-FDG positron emission tomography (PET) has been shown to identify early cardiac sarcoidosis with relatively high sensitivity. To date, simultaneous PET/MRI evaluation of cardiac inflammation and sarcoidosis has only been described in limited case reports. The objective of the proposed research is to evaluate the utility of simultaneous PET/MRI imaging in patients with cardiac sarcoidosis and other inflammatory cardiomyopathies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET MRI exam | – | Diagnostic Test: simultaneous combined 18F-FDG PET and cardiac MRI imagingsimultaneous combined 18F-FDG PET and cardiac MRI imaging (PET MRI) performed immediately after the PET CT exam. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18 years or older with known or suspected cardiac sarcoidosis or other inflammatory cardiomyopathy who are referred for clinically indicated 18F-FDG PET/CT imaging at University Health Network.
Key inclusion criteria (1 listed)
- The primary criterion for enrolment will be patients ≥18 years of age with known or suspected sarcoidosis or other inflammatory cardiomyopathy who are referred for clinically indicated 18F-FDG PET/CT imaging
Key exclusion criteria (1 listed)
- Standard cardiac MRI contraindications include arrhythmia, claustrophobia, history of allergic reaction or other contraindication to gadolinium-based contrast agent, impaired renal function with eGFR < 60 ml/min/1.73m2, pregnancy, breast-feeding, or any other general contraindication to MRI (pacemaker, cerebral aneurysm clips, shrapnel, etc).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| simultaneous combined 18F-FDG PET and cardiac MRI imagingPatients will undergo a research study performed with an integrated whole-body PET/MRI imaging system designed for simultaneous PET and MRI acquisition, immediately after standard of care PET/CT exam. | Diagnostic test | PET MRI exam |
Primary outcome
The incremental value of combined 18F-FDG PET and cardiac MRI imaging in the evaluation of patients with suspected cardiac sarcoidosis or cardiac inflammation
Time frame: Completion of enrollment, an average of two years
Patients will undergo standard clinical evaluation using modified consensus guidelines for the diagnosis of sarcoidosis. Following enrolment, patients will also undergo parallel assessment for cardiac involvement by PET/MRI. Comparison of cardiac involvement identified by modified consensus criteria and PET/MRI will be performed.
2 secondary outcomes
The differences in circulating plasma biomarkers between cardiac with suspected cardiac sarcoidosis and healthy people
Time frame: Completion of enrollment, an average of two years
The prognostic significance of PET-MRI imaging findings in patients with cardiac inflammation
Time frame: Through study completion, an average of three years
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 28 May 2024.
- Results publication: PubMed 34913098Cheung E, Ahmad S, Aitken M, Chan R, Iwanochko RM, Balter M, Metser U, Veit-Haibach P, Billia F, Moayedi Y, Ross HJ, Hanneman K. Combined simultaneous FDG-PET/MRI with T1 and T2 mapping as an imaging biomarker for the diagnosis and prognosis of suspected cardiac sarcoidosis. Eur J Hybrid Imaging. 2021 Dec 16;5(1):24. doi: 10.1186/s41824-021-00119-w.
- Results publication: PubMed 38076597Marschner CA, Aloufi F, Aitken M, Cheung E, Thavendiranathan P, Iwanochko RM, Balter M, Moayedi Y, Duero Posada J, Hanneman K. Combined FDG PET/MRI versus Standard-of-Care Imaging in the Evaluation of Cardiac Sarcoidosis. Radiol Cardiothorac Imaging. 2023 Sep 28;5(5):e220292. doi: 10.1148/ryct.220292. eCollection 2023 Oct.
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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.
Kate Hanneman, MD principal investigator
University Health Network, Toronto
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 Inflammatory Cardiomyopathy and Sarcoidosis, run by University Health Network, Toronto at 1 site in Canada.
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 1 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 28 May 2024. 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 Canada. 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?
The incremental value of combined 18F-FDG PET and cardiac MRI imaging in the evaluation of patients with suspected cardiac sarcoidosis or cardiac inflammation (time frame: Completion of enrollment, an average of two years). 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 NCT03356756, which also lists 2 linked publications.
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 28 May 2024.