SarcoidosisNCT02989480
PET-detected Myocardial Inflammation is a Characteristic of Cardiac Sarcoid But Not of ARVC
An observational study of Sarcoidosis and Arrhythmogenic Right Ventricular Cardiomyopathy, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
Arrhythmogenic right ventricular cardiomyopathy (ARVC) is a rare condition in which the heart muscle cells especially of the main pumping chamber (the 'ventricle') is replaced by fat and scar tissue. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sarcoidosis, Arrhythmogenic Right Ventricular Cardiomyopathy
- What is being tested?
- PET CT and Cardiac MRI
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2015to Jul 2019
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Twenty patients from the age of 18-70 will be studied. We will include 10 patients with cardiac sarcoidosis diagnosed according to the Japanese Ministry of Health and Welfare criteria. All patients will have histologically proven sarcoidosis (cardiac biopsy not mandatory) and no other potential cardiac disease. They will have no family history of cardiomyopathy. We will also study 10 patients with ARVC diagnosed according to the Task Force criteria with in addition either a positive family history for the condition or harbour a known pathological mutation associated with it.
Who may be able to join
- Twenty patients from the age of 18-70 will be studied. We will include 10 patients with cardiac sarcoidosis diagnosed according to the Japanese Ministry of Health and Welfare criteria. All patients will have histologically proven sarcoidosis (cardiac biopsy not mandatory) and no other potential cardiac disease. They will have no family history of cardiomyopathy. We will also study 10 patients with ARVC diagnosed according to the Task Force criteria with in addition either a positive family history for the condition or harbour a known pathological mutation associated with it.
Who cannot join
- patients outside the age limit defined above and those who do not fulfil our inclusion criteria for either cardiac sarcoidosis or ARVC will be excluded.
- unwillingness to participate
- patients with any contraindication to MR scanning
- pregnant or breast feeding women
- diabetes
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Aberdeen Royal Infirmary
Aberdeen, Aberdeenshire, AB25 2ZD
Paul Broadhurst, Consultant, 01224559308, paul.broadhurst@nhs.net
Dana Dawson, Consultant, 01224437969, dana.dawson@abdn.ac.uk
About this study
Official title: PET-detected Myocardial Inflammation is a Characteristic of Cardiac Sarcoid But Not of ARVC - a Feasibility Study
Arrhythmogenic right ventricular cardiomyopathy (ARVC) is a rare condition in which the heart muscle cells especially of the main pumping chamber (the 'ventricle') is replaced by fat and scar tissue. Sarcoidosis is a condition that can affect many organs but when it affects the heart patches of inflammation can result in scarring, especially of the ventricles. Both conditions can cause dangerous heart rhythms and sudden death. Sarcoidosis can be treated with inflammation suppressing treatment (steroids), as well as pacemakers and implantable defibrillators which shock the heart back to normal rhythm. ARVC is usually treated with implantable defibrillators. The diagnosis of either condition can be difficult and indeed distinguishing the two can be extremely challenging. Increasingly nuclear scans (PET) are used to identify inflammation in the heart in patients suspected of having cardiac sarcoid. It is not known whether patients with ARVC have abnormal PET scans.
Read the detailed description
Arrhythmogenic right ventricular cardiomyopathy (ARVC) is a rare inherited condition characterised pathologically by fibro-fatty replacement of myocytes usually (but not exclusively) within the right ventricle. The clinical consequences of this process are usually re-entrant ventricular arrhythmias which may be fatal and ARVC consequently is the third most common cause of sudden cardiac death in the young. Diagnosis involves imaging, electrocardiography, myocardial biopsy and genetic testing. Task Force criteria for the diagnosis have been established. Nevertheless the condition can be difficult to diagnose (or exclude), especially in less advanced disease, a common scenario in individuals with a family member suffering from the condition. To complicate the situation further, we and others have published recent reports suggesting that other infiltrative conditions within the heart especially sarcoidosis, may fulfil Task Force criteria, leading to a false positive diagnosis. This is a particular concern since the natural history and treatment options for these conditions are very different.
Sarcoidosis is a granulomatous disorder of unknown cause, predominantly affecting the lungs, reticuloendothelial systems and skin. Cardiac involvement at autopsy is found in up to 25% of affected individuals although clinical manifestations are only present in approximately 5%. Isolated cardiac sarcoidosis, without manifestations in other systems is rare. The non-caseating granulomas frequently infiltrate left ventricular \& septal myocardium although right ventricular involvement also occurs. Granulomas and resulting scar formation can cause conduction disturbances, cardiac failure and ventricular arrhythmias. Sudden death is not uncommon. Myocardial biopsy confirms the diagnosis but because of the patchy nature of the granulomatous process, the test is only positive in 50% of the affected individuals. Other investigations used to help make or support the diagnosis include echocardiography, MRI, electrocardiography, PET, and corroborating evidence from high resolution CT chest and skin biopsy. However, imaging findings may lack specificity for a precise aetiology. Cardiac MRI identifies areas of myocardial scar or fibrosis, which is the final step in the disease process. Although patterns of fibrosis have been well described in ARVC and cardiac sarcoidosis, significant overlap exists between these two diseases with regard to the exact location of fibrosis: for example ARVC can affect either or both ventricles. Typically, although affecting predominantly the RV, in advanced stages there is also a well described pattern of mid-wall patchy fibrosis in the basal infero-lateral wall of the left ventricle and sometimes in the inter-ventricular septum. Conversely, sarcoidosis typically affects the LV, and when fibrosis is found, the location is in the septal or infero-lateral territories. In sarcoid, RV enlargement can occur either due to granulomatous involvement within the RV myocardium, or secondary to the pulmonary hypertension associated with lung involvement. Cases of sarcoidosis where the RV is involved may be more difficult to diagnose: The RV enlargement and reduction in function overlap significantly with the Task Force Criteria for the CMR diagnosis of ARVC, furthermore, the pattern of late gadolinium enhancement is not sufficiently specific to guide the diagnosis to either ARVC or Cardiac Sarcoid with RV involvement.
- Being tested
- PET CT, Cardiac MRI
- Keywords
- Cardiomyopathy
- Medical subject headings
- Sarcoidosis, Arrhythmogenic Right Ventricular Dysplasia, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET CTRadiation
PET CT scans
Cardiac MRIOther
Cardiac MRI
| Study group | Role | What they receive |
|---|---|---|
| Sarcoidosis | Patients with cardiac sarcoidosis diagnosed according to the Japanese Ministry of Health and Welfare criteria will be included. All patients will have histologically proven sarcoidosis (cardiac biopsy not mandatory) and no other potential cardiac disease. They will have no family history of cardiomyopathy. Receives: Radiation: PET CT; Other: Cardiac MRI | |
| Arrhythmogenic RV cardiomyopathy | Patients with ARVC diagnosed according to the Task Force criteria with in addition either a positive family history for the condition or harbour a known pathological mutation associated with it. Receives: Radiation: PET CT; Other: Cardiac MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial inflammation or fibrosis by cardiac MRI and PET CT
Cardiac MRI and PET CT
Measured: Three hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study startAug 2015
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Grampian
- Responsible party
- Sponsor
- Investigators
- Paul Broadhurst, Consultant, Principal investigator, NHS Grampian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989480
- Sponsor's protocol ID
- 3/072/14
- Status last verified
- Oct 2018
- First submitted
- 20 Jan 2016
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Marcus FI, McKenna WJ, Sherrill D, Basso C, Bauce B, Bluemke DA, Calkins H, Corrado D, Cox MG, Daubert JP, Fontaine G, Gear K, Hauer R, Nava A, Picard MH, Protonotarios N, Saffitz JE, Sanborn DM, Steinberg JS, Tandri H, Thiene G, Towbin JA, Tsatsopoulou A, Wichter T, Zareba W. Diagnosis of arrhythmogenic right ventricular cardiomyopathy/dysplasia: proposed modification of the task force criteria. Circulation. 2010 Apr 6;121(13):1533-41. doi: 10.1161/CIRCULATIONAHA.108.840827. Epub 2010 Feb 19.
PubMed 20172911Dempsey OJ, Paterson EW, Kerr KM, Denison AR. Sarcoidosis. BMJ. 2009 Aug 28;339:b3206. doi: 10.1136/bmj.b3206. No abstract available.
PubMed 19717499Mohsen A, Panday M, Wetherold S, Jimenez A. Cardiac sarcoidosis mimicking arrhythmogenic right ventricular dysplasia with high defibrillation threshold requiring subcutaneous shocking coil implantation. Heart Lung Circ. 2012 Jan;21(1):46-9. doi: 10.1016/j.hlc.2011.08.013. Epub 2011 Oct 6.
PubMed 21982156Sen-Chowdhry S, Morgan RD, Chambers JC, McKenna WJ. Arrhythmogenic cardiomyopathy: etiology, diagnosis, and treatment. Annu Rev Med. 2010;61:233-53. doi: 10.1146/annurev.med.052208.130419.
PubMed 20059337Patel MR, Cawley PJ, Heitner JF, Klem I, Parker MA, Jaroudi WA, Meine TJ, White JB, Elliott MD, Kim HW, Judd RM, Kim RJ. Detection of myocardial damage in patients with sarcoidosis. Circulation. 2009 Nov 17;120(20):1969-77. doi: 10.1161/CIRCULATIONAHA.109.851352. Epub 2009 Nov 2.
PubMed 19884472Lobert P, Brown RK, Dvorak RA, Corbett JR, Kazerooni EA, Wong KK. Spectrum of physiological and pathological cardiac and pericardial uptake of FDG in oncology PET-CT. Clin Radiol. 2013 Jan;68(1):e59-71. doi: 10.1016/j.crad.2012.09.007. Epub 2012 Nov 22.
PubMed 23177651Campian ME, Verberne HJ, Hardziyenka M, de Groot EA, van Moerkerken AF, van Eck-Smit BL, Tan HL. Assessment of inflammation in patients with arrhythmogenic right ventricular cardiomyopathy/dysplasia. Eur J Nucl Med Mol Imaging. 2010 Nov;37(11):2079-85. doi: 10.1007/s00259-010-1525-y. Epub 2010 Jul 6.
PubMed 20603720Soejima K, Yada H. The work-up and management of patients with apparent or subclinical cardiac sarcoidosis: with emphasis on the associated heart rhythm abnormalities. J Cardiovasc Electrophysiol. 2009 May;20(5):578-83. doi: 10.1111/j.1540-8167.2008.01417.x. Epub 2009 Jan 9.
PubMed 19175448Williams G, Kolodny GM. Suppression of myocardial 18F-FDG uptake by preparing patients with a high-fat, low-carbohydrate diet. AJR Am J Roentgenol. 2008 Feb;190(2):W151-6. doi: 10.2214/AJR.07.2409.
PubMed 18212199Langah R, Spicer K, Gebregziabher M, Gordon L. Effectiveness of prolonged fasting 18f-FDG PET-CT in the detection of cardiac sarcoidosis. J Nucl Cardiol. 2009 Sep-Oct;16(5):801-10. doi: 10.1007/s12350-009-9110-0. Epub 2009 Jun 23.
PubMed 19548047Alexandrino FB, Faaborg-Andersen CC, daSilva-deAbreu A. Anticoagulation in patients with atrial fibrillation and heart failure: More than meets the eye? Int J Cardiol. 2024 Feb 15;397:131591. doi: 10.1016/j.ijcard.2023.131591. Epub 2023 Nov 17. No abstract available.
PubMed 37979797
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET-detected Myocardial Inflammation is a Characteristic of Cardiac Sarcoid But Not of ARVC - a Feasibility Study
- ClinicalTrials.gov ID
- NCT02989480
- Acronym / sponsor ID
- 3/072/14
- Keywords
- Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- NHS Grampian
- Study start
- Aug 2015
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 12 Dec 2016 (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.
Arrhythmogenic right ventricular cardiomyopathy (ARVC) is a rare condition in which the heart muscle cells especially of the main pumping chamber (the 'ventricle') is replaced by fat and scar tissue. Sarcoidosis is a condition that can affect many organs but when it affects the heart patches of inflammation can result in scarring, especially of the ventricles. Both conditions can cause dangerous heart rhythms and sudden death. Sarcoidosis can be treated with inflammation suppressing treatment (steroids), as well as pacemakers and implantable defibrillators which shock the heart back to normal rhythm. ARVC is usually treated with implantable defibrillators. The diagnosis of either condition can be difficult and indeed distinguishing the two can be extremely challenging. Increasingly nuclear scans (PET) are used to identify inflammation in the heart in patients suspected of having cardiac sarcoid. It is not known whether patients with ARVC have abnormal PET scans.
Detailed description
Arrhythmogenic right ventricular cardiomyopathy (ARVC) is a rare inherited condition characterised pathologically by fibro-fatty replacement of myocytes usually (but not exclusively) within the right ventricle. The clinical consequences of this process are usually re-entrant ventricular arrhythmias which may be fatal and ARVC consequently is the third most common cause of sudden cardiac death in the young. Diagnosis involves imaging, electrocardiography, myocardial biopsy and genetic testing. Task Force criteria for the diagnosis have been established. Nevertheless the condition can be difficult to diagnose (or exclude), especially in less advanced disease, a common scenario in individuals with a family member suffering from the condition. To complicate the situation further, we and others have published recent reports suggesting that other infiltrative conditions within the heart especially sarcoidosis, may fulfil Task Force criteria, leading to a false positive diagnosis. This is a particular concern since the natural history and treatment options for these conditions are very different.
Sarcoidosis is a granulomatous disorder of unknown cause, predominantly affecting the lungs, reticuloendothelial systems and skin. Cardiac involvement at autopsy is found in up to 25% of affected individuals although clinical manifestations are only present in approximately 5%. Isolated cardiac sarcoidosis, without manifestations in other systems is rare. The non-caseating granulomas frequently infiltrate left ventricular \& septal myocardium although right ventricular involvement also occurs. Granulomas and resulting scar formation can cause conduction disturbances, cardiac failure and ventricular arrhythmias. Sudden death is not uncommon. Myocardial biopsy confirms the diagnosis but because of the patchy nature of the granulomatous process, the test is only positive in 50% of the affected individuals. Other investigations used to help make or support the diagnosis include echocardiography, MRI, electrocardiography, PET, and corroborating evidence from high resolution CT chest and skin biopsy. However, imaging findings may lack specificity for a precise aetiology. Cardiac MRI identifies areas of myocardial scar or fibrosis, which is the final step in the disease process. Although patterns of fibrosis have been well described in ARVC and cardiac sarcoidosis, significant overlap exists between these two diseases with regard to the exact location of fibrosis: for example ARVC can affect either or both ventricles. Typically, although affecting predominantly the RV, in advanced stages there is also a well described pattern of mid-wall patchy fibrosis in the basal infero-lateral wall of the left ventricle and sometimes in the inter-ventricular septum. Conversely, sarcoidosis typically affects the LV, and when fibrosis is found, the location is in the septal or infero-lateral territories. In sarcoid, RV enlargement can occur either due to granulomatous involvement within the RV myocardium, or secondary to the pulmonary hypertension associated with lung involvement. Cases of sarcoidosis where the RV is involved may be more difficult to diagnose: The RV enlargement and reduction in function overlap significantly with the Task Force Criteria for the CMR diagnosis of ARVC, furthermore, the pattern of late gadolinium enhancement is not sufficiently specific to guide the diagnosis to either ARVC or Cardiac Sarcoid with RV involvement.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sarcoidosis | – | Radiation: PET CT, Other: Cardiac MRIPatients with cardiac sarcoidosis diagnosed according to the Japanese Ministry of Health and Welfare criteria will be included. All patients will have histologically proven sarcoidosis (cardiac biopsy not mandatory) and no other potential cardiac disease. They will have no family history of cardiomyopathy. |
| Arrhythmogenic RV cardiomyopathy | – | Radiation: PET CT, Other: Cardiac MRIPatients with ARVC diagnosed according to the Task Force criteria with in addition either a positive family history for the condition or harbour a known pathological mutation associated with it. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Twenty patients from the age of 18-70 will be studied. We will include 10 patients with cardiac sarcoidosis diagnosed according to the Japanese Ministry of Health and Welfare criteria. All patients will have histologically proven sarcoidosis (cardiac biopsy not mandatory) and no other potential cardiac disease. They will have no family history of cardiomyopathy. We will also study 10 patients with ARVC diagnosed according to the Task Force criteria with in addition either a positive family history for the condition or harbour a known pathological mutation associated with it.
Key inclusion criteria (1 listed)
- Twenty patients from the age of 18-70 will be studied. We will include 10 patients with cardiac sarcoidosis diagnosed according to the Japanese Ministry of Health and Welfare criteria. All patients will have histologically proven sarcoidosis (cardiac biopsy not mandatory) and no other potential cardiac disease. They will have no family history of cardiomyopathy. We will also study 10 patients with ARVC diagnosed according to the Task Force criteria with in addition either a positive family history for the condition or harbour a known pathological mutation associated with it.
Key exclusion criteria (5 listed)
- patients outside the age limit defined above and those who do not fulfil our inclusion criteria for either cardiac sarcoidosis or ARVC will be excluded.
- unwillingness to participate
- patients with any contraindication to MR scanning
- pregnant or breast feeding women
- diabetes
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 |
|---|---|---|
| PET CTPET CT scans | Radiation | Arrhythmogenic RV cardiomyopathy, Sarcoidosis |
| Cardiac MRICardiac MRI | Other | Arrhythmogenic RV cardiomyopathy, Sarcoidosis |
Primary outcome
Myocardial inflammation or fibrosis by cardiac MRI and PET CT
Time frame: Three hours
Cardiac MRI and PET CT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Background: PubMed 20172911Marcus FI, McKenna WJ, Sherrill D, Basso C, Bauce B, Bluemke DA, Calkins H, Corrado D, Cox MG, Daubert JP, Fontaine G, Gear K, Hauer R, Nava A, Picard MH, Protonotarios N, Saffitz JE, Sanborn DM, Steinberg JS, Tandri H, Thiene G, Towbin JA, Tsatsopoulou A, Wichter T, Zareba W. Diagnosis of arrhythmogenic right ventricular cardiomyopathy/dysplasia: proposed modification of the task force criteria. Circulation. 2010 Apr 6;121(13):1533-41. doi: 10.1161/CIRCULATIONAHA.108.840827. Epub 2010 Feb 19.
- Background: PubMed 19717499Dempsey OJ, Paterson EW, Kerr KM, Denison AR. Sarcoidosis. BMJ. 2009 Aug 28;339:b3206. doi: 10.1136/bmj.b3206. No abstract available.
- Background: PubMed 21982156Mohsen A, Panday M, Wetherold S, Jimenez A. Cardiac sarcoidosis mimicking arrhythmogenic right ventricular dysplasia with high defibrillation threshold requiring subcutaneous shocking coil implantation. Heart Lung Circ. 2012 Jan;21(1):46-9. doi: 10.1016/j.hlc.2011.08.013. Epub 2011 Oct 6.
- Background: PubMed 20059337Sen-Chowdhry S, Morgan RD, Chambers JC, McKenna WJ. Arrhythmogenic cardiomyopathy: etiology, diagnosis, and treatment. Annu Rev Med. 2010;61:233-53. doi: 10.1146/annurev.med.052208.130419.
- Background: PubMed 19884472Patel MR, Cawley PJ, Heitner JF, Klem I, Parker MA, Jaroudi WA, Meine TJ, White JB, Elliott MD, Kim HW, Judd RM, Kim RJ. Detection of myocardial damage in patients with sarcoidosis. Circulation. 2009 Nov 17;120(20):1969-77. doi: 10.1161/CIRCULATIONAHA.109.851352. Epub 2009 Nov 2.
- Background: PubMed 23177651Lobert P, Brown RK, Dvorak RA, Corbett JR, Kazerooni EA, Wong KK. Spectrum of physiological and pathological cardiac and pericardial uptake of FDG in oncology PET-CT. Clin Radiol. 2013 Jan;68(1):e59-71. doi: 10.1016/j.crad.2012.09.007. Epub 2012 Nov 22.
- Background: PubMed 20603720Campian ME, Verberne HJ, Hardziyenka M, de Groot EA, van Moerkerken AF, van Eck-Smit BL, Tan HL. Assessment of inflammation in patients with arrhythmogenic right ventricular cardiomyopathy/dysplasia. Eur J Nucl Med Mol Imaging. 2010 Nov;37(11):2079-85. doi: 10.1007/s00259-010-1525-y. Epub 2010 Jul 6.
- Background: PubMed 19175448Soejima K, Yada H. The work-up and management of patients with apparent or subclinical cardiac sarcoidosis: with emphasis on the associated heart rhythm abnormalities. J Cardiovasc Electrophysiol. 2009 May;20(5):578-83. doi: 10.1111/j.1540-8167.2008.01417.x. Epub 2009 Jan 9.
- Background: PubMed 18212199Williams G, Kolodny GM. Suppression of myocardial 18F-FDG uptake by preparing patients with a high-fat, low-carbohydrate diet. AJR Am J Roentgenol. 2008 Feb;190(2):W151-6. doi: 10.2214/AJR.07.2409.
- Background: PubMed 19548047Langah R, Spicer K, Gebregziabher M, Gordon L. Effectiveness of prolonged fasting 18f-FDG PET-CT in the detection of cardiac sarcoidosis. J Nucl Cardiol. 2009 Sep-Oct;16(5):801-10. doi: 10.1007/s12350-009-9110-0. Epub 2009 Jun 23.
- Derived from this study: PubMed 37979797Alexandrino FB, Faaborg-Andersen CC, daSilva-deAbreu A. Anticoagulation in patients with atrial fibrillation and heart failure: More than meets the eye? Int J Cardiol. 2024 Feb 15;397:131591. doi: 10.1016/j.ijcard.2023.131591. Epub 2023 Nov 17. No abstract available.
- Individual participant dataSharing planned: No
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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.
Paul Broadhurst, Consultant principal investigator
NHS Grampian
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 Arrhythmogenic Right Ventricular Cardiomyopathy, run by University of Aberdeen at 1 site in United Kingdom.
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 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: status not confirmed, as of the sponsor's last update on 11 Oct 2018. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul Broadhurst, Consultant (01224559308, paul.broadhurst@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial inflammation or fibrosis by cardiac MRI and PET CT (time frame: Three hours). 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 NCT02989480, which also lists 11 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 11 Oct 2018.