Interstitial Lung DiseaseCASPANCT03599414
CASPA: CArdiac Sarcoidosis in PApworth
An observational study of Interstitial Lung Disease and Pulmonary Sarcoidosis, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease, Pulmonary Sarcoidosis, Cardiac Sarcoidosis
- How many people
- 104 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Jun 2017to 8 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diagnosis of pulmonary sarcoidosis
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Papworth Hospital
Papworth Everard, Cambridgeshire, CB23 3RE
About this study
Official title: 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.
Read more
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.
- Keywords
- sarcoidosis, cardiac, MRI, Echocardiography, pulmonary, cytokine
- Medical subject headings
- Lung Diseases, Interstitial, Sarcoidosis, Pulmonary, Sarcoidosis
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of cardiac sarcoidosis in patients with pulmonary sarcoidosis
The prevalence of cardiac sarcoidosis in patients with pulmonary sarcoidosis
Measured: on Day 1
Secondary outcomes (2)
Cytokine and Proteomic profiling
Completion of cytokine and proteomic profiling of patients with pulmonary sarcoidosis
Measured: after 1 year
Diagnosis of cardiac sarcoidosis
Diagnosis of cardiac sarcoidosis by combining signal averaged ECG, speckle tracking echocardiography and 24 hour holter monitoring
Measured: on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start29 Jun 2017
- Primary completion24 Mar 2020
- Study completion8 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Papworth Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- Imperial College London
- Responsible party
- Sponsor
- Investigators
- Muhunthan Thillai, Principal investigator, Royal Papworth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599414
- Sponsor's protocol ID
- P02262
- Acronym
- CASPA
- Status last verified
- Jun 2023
- First submitted
- 5 Jun 2018
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CASPA (CArdiac Sarcoidosis in PApworth): Improving the Diagnosis of Cardiac Disease in Patients With Pulmonary Sarcoidosis
- ClinicalTrials.gov ID
- NCT03599414
- Acronym / sponsor ID
- CASPA / P02262
- Keywords
- sarcoidosis, cardiac, MRI, Echocardiography, pulmonary, cytokine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Papworth Hospital NHS Foundation TrustOther government
- Collaborators
- Imperial College London
- Study start
- 29 Jun 2017 (actual)
- Primary completion
- 24 Mar 2020 (actual)
- Study completion
- 8 Mar 2023 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosis of pulmonary sarcoidosis
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Cytokine and Proteomic profiling
Time frame: after 1 year
Diagnosis of cardiac sarcoidosis
Time frame: on Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhunthan Thillai principal investigator
Royal Papworth Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Disease and Pulmonary Sarcoidosis, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of cardiac sarcoidosis in patients with pulmonary sarcoidosis (time frame: on Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.