CASPA: CArdiac Sarcoidosis in PApworth

NCT ID: NCT03599414

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 104 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-29
• Study Completion Date: 2023-03-08

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.

Conditions

Interstitial Lung Disease; Pulmonary Sarcoidosis; Cardiac Sarcoidosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imperial College London

OTHER

Sponsor Role: collaborator

Papworth Hospital NHS Foundation Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Muhunthan Thillai

Role: PRINCIPAL_INVESTIGATOR

Royal Papworth Hospital

Locations

Royal Papworth Hospital

Papworth Everard, Cambridgeshire, United Kingdom

Countries

United Kingdom

Other Identifiers

P02262

Identifier Type: -

Identifier Source: org_study_id