Clinical trial NCT03599414: CASPA: CArdiac Sarcoidosis in PApworth
Official title: CASPA (CArdiac Sarcoidosis in PApworth): Improving the Diagnosis of Cardiac Disease in Patients With Pulmonary Sarcoidosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Interstitial Lung Disease
Pulmonary Sarcoidosis
Cardiac Sarcoidosis
Keywords: sarcoidosis
cardiac
MRI
Echocardiography
pulmonary
cytokine
Lead sponsor: Papworth Hospital NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: Imperial College London
First posted: 2018-07-26
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosis of pulmonary sarcoidosis

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Newly referred adult patients with pulmonary sarcoidosis and diagnosis made at multidisciplinary meeting as per current joint BTS/ATS guidance
* Patient may be on ≤10mg prednisolone at time of recruitment (if already started at another site prior to referral).
* Able to give informed consent and able to comply with protocol
* ≥\>18 yrs

Exclusion Criteria:

* History of other cardiac disease (e.g. coronary artery disease)cardiac surgery or previous myocardial infarction (MI)
* Inability to give informed consent
* \<18 yrs
* Patient may be on \>10mg prednisolone at time of recruitment (if already started at another site prior to referral).
* On non-steroidal medication including methotrexate
* Pregnancy
* Alcoholism
* Illicit drug abuse

Exclusion criteria for MRI:

* Cardiac pacemakers
* Surgical clips in the head (particularly aneurysm clips)
* Electronic inner ear implants (bionic ears)
* Ocular metal fragments • Electronic stimulators • Implanted pumps
* Severe claustrophobia

Primary outcomes:
measure: The prevalence of cardiac sarcoidosis in patients with pulmonary sarcoidosis
timeFrame: on Day 1
Secondary outcomes:
measure: Cytokine and Proteomic profiling
timeFrame: after 1 year
measure: Diagnosis of cardiac sarcoidosis
timeFrame: on Day 1
Other outcomes:
Locations:
city: Papworth Everard
country: United Kingdom
facility: Royal Papworth Hospital
state: Cambridgeshire
Study officials:
affiliation: Royal Papworth Hospital
name: Muhunthan Thillai
role: PRINCIPAL_INVESTIGATOR
References: