Plain English Summary
Background and study aims
Sarcoidosis is a rare condition that causes small patches of red and swollen tissue, called granulomas, to develop in the organs of the body. Although it is more commonly affects organs such as lungs, skin and lymph nodes it can affect any organ in the body, including the heart (cardiac sarcoidosis). Cardiac sarcoidosis is quoted in studies as affecting 25% of patients with sarcoidosis, the most common presentation being sudden death. Despite this there are no guidelines surrounding its management or any screening process to identify those at high risk.
This study aims to screen 100 patients with a new diagnosis of sarcoidosis via ECG (electrocardiogram), echocardiography, 48-hour Holter monitor, and finally the gold standard of cardiac MRI (magnetic resonance imaging) for cardiac involvement.
Who can participate?
Any patient between 18 and 65 years old with no other history of cardiovascular disease and no contraindication to a cardiac MRI.
What does the study involve?
Before the cardiac MRI each patient will be placed into two groups based on findings from initial investigations: 1. Suspected to have cardiac sarcoid. 2. Not suspected to have cardiac sarcoid. The results will be compared to those of the cardiac MRI. Each patient found to have cardiac sarcoid would be followed up for 1 year following diagnosis to look at disease progression and hopefully give some insight into management, especially with regards to the controversial topic of the need for an implantable cardioverter-defibrillator (ICD). In doing so we hope to find how common a problem it is, to assess the place of simple screening tools in guiding more detailed and expensive investigations, laying the foundation for a screening process. We also hope to look for any clinical evidence that could be used to help in the decision-making process behind the use of ICDs in this population.
What are the possible benefits and risks of participating?
The benefits include catching a very hard to diagnose complication, thus facilitating its treatment. There are no particular risks but drawbacks include a large amount of time and effort on behalf of each patient.
Where is the study run from?
The study will hopefully be run from the Countess of Chester Hospital depending on the number of new sarcoidosis patients we get. Patients will have their cardiac MRI at the Royal Liverpool University Hospital, UK.
When is the study starting and how long is it expected to run for?
The study started in September 2013 and it will take about a year to recruit the patients and collect the data and another year to finish follow-up.
Who is funding the study?
Countess of Chester Hospital NHS Foundation Trust, UK.
Who is the main contact?
Dr Mohammed Meah, Countess of Chester Hospital NHS Foundation Trust
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Development of a screening tool for cardiac involvement in the Sarcoidosis population using cardiac magnetic resonance imaging (MRI) as the gold standard: an observational study
Acronym
Study hypothesis
Sarcoidosis is a granulomatous disease of unknown aetiology. Although it is more commonly affects organs such as lungs, skin and lymph nodes it can affect any organ in the body. Cardiac sarcoid can occur alone or concurrently with multiple organ involvement. It is difficult to diagnose, as often stays clinically silent, though its presence is more common in the sarcoid population in those with cardiac symptoms. It is thought to affect at least 25% of patients with sarcoidosis.
Simple diagnostic tools are useful in the screening of patients with sarcoidosis for cardiac involvement, and allow for risk stratification with regards to sudden cardiac death.
Ethics approval
Not provided at time of registration
Study design
Observational longitudinal study
Primary study design
Observational
Secondary study design
Other
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Sarcoidosis
Intervention
Patients will be selected from the known sarcoid population at Chester. Patients will be prospectively recruited following new diagnosis of non-cardiac sarcoidosis. They will be put through a screening process beginning with physical examination, ECG, 48-hour Holter monitoring, echocardiogram with tissue Doppler imaging, exercise tolerance test (to exclude ischaemic/coronary artery disease), and finally cardiac MRI as the gold standard. Those found to have cardiac sarcoid will be treated as normal. They will be followed up for a year (once at 30 days, 6 months and 1 year). All the investigations apart from cardiac MRI will be run again at least once more allowing an assessment of disease progression.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Presence of cardiac sarcoid as per cardiac MRI. Measured at baseline, and again in 1, 6 and 12 months following baseline investigations.
Secondary outcome measures
1. Biomarkers
2. ECG and Echo findings
Measured at baseline, and again in 1,6 and 12 months following baseline investigations.
Overall trial start date
09/09/2013
Overall trial end date
09/09/2015
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with known Sarcoidosis
2. Male and female, aged 18-65 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40-50
Participant exclusion criteria
1. Contraindication for cardiac MRI
2. Any other cardiovascular disease (an exercise tolerance test will be done on all participants to assess for ischaemic heart disease)
Recruitment start date
09/09/2013
Recruitment end date
09/09/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Countess of Chester Hospital NHS Foundation Trust
Chester
CH2 1UL
United Kingdom
Funders
Funder type
Hospital/treatment centre
Funder name
Countess of Chester Hospital NHS Foundation Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary