CASPA: CArdiac Sarcoidosis in PApworth (CASPA)
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|ClinicalTrials.gov Identifier: NCT03599414|
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : September 16, 2020
Sarcoidosis is a disease of unknown cause which affects adults of all ethnic backgrounds. Clumps of tissue called granulomas develop primarily in the lungs, but can damage other organs, especially the heart. Anecdotal evidence from autopsy studies suggests the heart is affected in up to 68% of patients, but there is much uncertainty about this figure.
If undetected and untreated, it can lead to serious complications or even sudden death. The current recommendation is to perform heart tracings (ECG s) on all patients, but this detects fewer than half of those with heart involvement.
Blood markers traditionally used to diagnose heart disease are unreliable, meaning there is no simple blood test in use.
The investigators propose a study with three aims. Firstly, identify the true prevalence of heart disease by performing Magnetic Resonance Imaging (MRI) scans on a group of patients with newly diagnosed lung sarcoidosis. Those found to have heart disease will have specialist (but routine) electrical heart tests. Secondly, (and perhaps the most immediate and clinically relevant) to identify the best method of diagnosing heart involvement using a combination of three simple tests: advanced ECG, 24-hour continuous ECG and a new type of computerised ultrasound scan. Thirdly, to identify proteins in the blood that could be used to develop a simple blood test for heart involvement in patients with lung sarcoidosis.
|Condition or disease|
|Interstitial Lung Disease Pulmonary Sarcoidosis Cardiac Sarcoidosis|
|Study Type :||Observational|
|Estimated Enrollment :||104 participants|
|Official Title:||CASPA (CArdiac Sarcoidosis in PApworth): Improving the Diagnosis of Cardiac Disease in Patients With Pulmonary Sarcoidosis|
|Actual Study Start Date :||June 29, 2017|
|Actual Primary Completion Date :||March 24, 2020|
|Estimated Study Completion Date :||November 30, 2020|
- The prevalence of cardiac sarcoidosis in patients with pulmonary sarcoidosis [ Time Frame: on Day 1 ]The prevalence of cardiac sarcoidosis in patients with pulmonary sarcoidosis
- Cytokine and Proteomic profiling [ Time Frame: after 1 year ]Completion of cytokine and proteomic profiling of patients with pulmonary sarcoidosis
- Diagnosis of cardiac sarcoidosis [ Time Frame: on Day 1 ]Diagnosis of cardiac sarcoidosis by combining signal averaged ECG, speckle tracking echocardiography and 24 hour holter monitoring
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03599414
|Contact: Muhunthan Thillaifirstname.lastname@example.org|
|Contact: Victoria Stonemanemail@example.com|
|Principal Investigator:||Muhunthan Thillai||Royal Papworth Hospital|