CASPA: CArdiac Sarcoidosis in PApworth (CASPA)

CASPA (CArdiac Sarcoidosis in PApworth): Improving the Diagnosis of Cardiac Disease in Patients With Pulmonary Sarcoidosis

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.

Study Overview

• Status: Completed
• Conditions: Interstitial Lung Disease; Cardiac Sarcoidosis; Pulmonary Sarcoidosis

• Study Type: Observational
• Enrollment (Actual): 104

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridgeshire
    • Papworth Everard, Cambridgeshire, United Kingdom, CB23 3RE
      • Royal Papworth Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosis of pulmonary sarcoidosis

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The prevalence of cardiac sarcoidosis in patients with pulmonary sarcoidosis	The prevalence of cardiac sarcoidosis in patients with pulmonary sarcoidosis	on Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cytokine and Proteomic profiling	Completion of cytokine and proteomic profiling of patients with pulmonary sarcoidosis	after 1 year
Diagnosis of cardiac sarcoidosis	Diagnosis of cardiac sarcoidosis by combining signal averaged ECG, speckle tracking echocardiography and 24 hour holter monitoring	on Day 1

Collaborators and Investigators

• Sponsor: Papworth Hospital NHS Foundation Trust
• Collaborators: Imperial College London
• Investigators: Principal Investigator: Muhunthan Thillai, Royal Papworth Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2017
• Primary Completion (Actual): March 24, 2020
• Study Completion (Actual): March 8, 2023

Study Registration Dates

• First Submitted: June 5, 2018
• First Submitted That Met QC Criteria: July 23, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Estimated): June 16, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: MRI; Echocardiography; cytokine; cardiac; pulmonary; sarcoidosis
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Hypersensitivity; Hypersensitivity, Delayed; Lung Diseases; Lung Diseases, Interstitial; Sarcoidosis, Pulmonary; Sarcoidosis
• Other Study ID Numbers: P02262

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No