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CASPA: CArdiac Sarcoidosis in PApworth (CASPA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03599414
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : September 16, 2020
Sponsor:
Collaborator:
Imperial College London
Information provided by (Responsible Party):
Papworth Hospital NHS Foundation Trust

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.


Condition or disease
Interstitial Lung Disease Pulmonary Sarcoidosis Cardiac Sarcoidosis

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Study Type : Observational
Estimated Enrollment : 104 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Cytokine and Proteomic profiling [ Time Frame: after 1 year ]
    Completion of cytokine and proteomic profiling of patients with pulmonary sarcoidosis

  2. 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
Serum


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with diagnosis of pulmonary sarcoidosis
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

Information from the National Library of Medicine

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


Contacts
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Contact: Muhunthan Thillai 01480366359 muhunthan.thillai@nhs.net
Contact: Victoria Stoneman 01223639865 victoria.stoneman@nhs.net

Locations
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United Kingdom
Royal Papworth Hospital Recruiting
Papworth Everard, Cambridgeshire, United Kingdom, CB23 3RE
Contact: Victoria Stoneman, PhD    01223639865    victoria.stoneman@nhs.net   
Contact: Jennifer Gray    01223639717    jennifer.gray13@nhs.net   
Sponsors and Collaborators
Papworth Hospital NHS Foundation Trust
Imperial College London
Investigators
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Principal Investigator: Muhunthan Thillai Royal Papworth Hospital
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Responsible Party: Papworth Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03599414    
Other Study ID Numbers: P02262
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Papworth Hospital NHS Foundation Trust:
sarcoidosis
cardiac
MRI
Echocardiography
pulmonary
cytokine
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Interstitial
Sarcoidosis, Pulmonary
Sarcoidosis
Respiratory Tract Diseases
Lymphoproliferative Disorders
Lymphatic Diseases