CASPA: CArdiac Sarcoidosis in PApworth

NCT03599414 | Completed

• 1 other identifier: P02262
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

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

Keywords

sarcoidosis; cardiac; MRI; Echocardiography; pulmonary; cytokine

Outcome Measures

Primary Outcomes (1)

• The prevalence of cardiac sarcoidosis in patients with pulmonary sarcoidosis

  The prevalence of cardiac sarcoidosis in patients with pulmonary sarcoidosis

  on Day 1

Secondary Outcomes (2)

• Cytokine and Proteomic profiling

  after 1 year

• Diagnosis of cardiac sarcoidosis

  on Day 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosis of pulmonary sarcoidosis

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Papworth Hospital NHS Foundation Trust: lead
• Imperial College London: collaborator

Study Sites (1)

Royal Papworth Hospital

Papworth Everard, Cambridgeshire, CB23 3RE, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum

MeSH Terms

Conditions

Lung Diseases, Interstitial; Sarcoidosis, Pulmonary; Sarcoidosis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Study Officials

• Muhunthan Thillai

  Royal Papworth Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: July 26, 2018
• Study Start: June 29, 2017
• Primary Completion: March 24, 2020
• Study Completion: March 8, 2023
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)