ILDNCT06198608
Misdiagnosis Between Interstitial Lung Disease and Cardiac Patients
An observational study of ILD, run by Assiut University.
Trial summary
Aim of the study To determine the frequency misdiagnosis of cardiac congestion as interstitial lung disease based on initial High Resolution CT interpretation alone. To identify specific HRCT findings that are more commonly associated with misdiagnosis versus correct diagnosis of the underlying condition. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- ILD
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 30 Dec 2024
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: prospective observational study design. Inclusion of patients who underwent HRCT for suspected interstitial lung disease or cardiac congestion. HRCT scans by experienced radiologists who are blinded to the initial interpretation and final diagnosis. Development of specific diagnostic criteria or guidelines to differentiate between interstitial lung disease and cardiac congestion based on HRCT findings. Collection of echocardiogram,lab results, clinical follow up to determine finial diagnosis. Comparison of Initial HRCT Interpretation: Comparison of the initial HRCT interpretation with the final diagnosis to determine the rate of misdiagnosis.
Who may be able to join
- Patients who underwent HRCT imaging of the chest for evaluation of suspected interstitial lung disease
- Initial radiology report included a definitive diagnosis of interstitial lung disease patterns
- Age 18+ years
- No prior history of pulmonary or cardiac
Who cannot join
- Inconclusive or unclear initial HRCT report
- Underlying diagnosis other than interstitial lung disease or cardiac congestion
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Interstitial Lung Disease Misdiagnosis in Cardiac Patients
Aim of the study To determine the frequency misdiagnosis of cardiac congestion as interstitial lung disease based on initial High Resolution CT interpretation alone.
To identify specific HRCT findings that are more commonly associated with misdiagnosis versus correct diagnosis of the underlying condition.
To establish diagnostic criteria or HRCT patterns that distinguish cardiac congestion from interstitial lung disease
Read the detailed description
Observational study of 150 patients found that cardiac congestion was misdiagnosed as interstitial lung disease in 24% of cases on initial HRCT imaging alone. Echocardiography and clinical correlation were needed to make the correct diagnosis .
Misdiagnosis can lead to inappropriate treatment with immunosuppressive drugs which could exacerbate right heart failure in patients who actually have cardiac congestion. Correct diagnosis is important for prognosis and management.
Subtle findings like upper lobe predominance of opacities, septal lines and a mosaic attenuation pattern on HRCT favor interstitial lung disease, while diffuse ground glass with central and perihilar distribution favors cardiac congestion .
Associated findings on HRCT like enlarged cardiac silhouette, pleural and pericardial effusions help suggest the diagnosis of cardiac congestion over idiopathic interstitial pneumonia .
Integrating clinical data on risk factors for heart failure, echocardiography findings and follow-up imaging response to diuretic therapy can help differentiate the two conditions when HRCT is non-specific
- Conditions
- ILD
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of initial HRCT interpretation
(percentage of cases initially read as interstitial lung disease that were later found to be cardiac congestion)
Measured: baseline
Secondary outcomes (1)
Time to correct diagnosis
Mean or median number of days/months between initial misdiagnosis on HRCT and reaching accurate diagnosis of cardiac congestion
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start1 Jan 2024 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ILDStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hend Mohamed Sayed Mohamed, Assiut University
- Investigators
- marwan sayed, MD, Study chair, lecture in cardiac diseasessamaa elkossi, MD, Study chair, Lecture inradiology departement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198608
- Sponsor's protocol ID
- ILD&Cardiac patient
- Status last verified
- Dec 2023
- First submitted
- 26 Dec 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nathan SD, Pastre J, Ksovreli I, Barnett S, King C, Aryal S, Ahmad K, Fukuda C, Ramalingam V, Chung JH. HRCT evaluation of patients with interstitial lung disease: comparison of the 2018 and 2011 diagnostic guidelines. Ther Adv Respir Dis. 2020 Jan-Dec;14:1753466620968496. doi: 10.1177/1753466620968496.
PubMed 33121391Case AH, Beegle S, Hotchkin DL, Kaelin T, Kim HJ, Podolanczuk AJ, Ramaswamy M, Remolina C, Salvatore MM, Tu C, de Andrade JA. Defining the pathway to timely diagnosis and treatment of interstitial lung disease: a US Delphi survey. BMJ Open Respir Res. 2023 Nov 24;10(1):e001594. doi: 10.1136/bmjresp-2022-001594.
PubMed 38007235
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interstitial Lung Disease Misdiagnosis in Cardiac Patients
- ClinicalTrials.gov ID
- NCT06198608
- Acronym / sponsor ID
- ILD&Cardiac patient
- Conditions
- ILD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 10 Jan 2024 (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.
Aim of the study To determine the frequency misdiagnosis of cardiac congestion as interstitial lung disease based on initial High Resolution CT interpretation alone.
To identify specific HRCT findings that are more commonly associated with misdiagnosis versus correct diagnosis of the underlying condition.
To establish diagnostic criteria or HRCT patterns that distinguish cardiac congestion from interstitial lung disease
Detailed description
Observational study of 150 patients found that cardiac congestion was misdiagnosed as interstitial lung disease in 24% of cases on initial HRCT imaging alone. Echocardiography and clinical correlation were needed to make the correct diagnosis .
Misdiagnosis can lead to inappropriate treatment with immunosuppressive drugs which could exacerbate right heart failure in patients who actually have cardiac congestion. Correct diagnosis is important for prognosis and management.
Subtle findings like upper lobe predominance of opacities, septal lines and a mosaic attenuation pattern on HRCT favor interstitial lung disease, while diffuse ground glass with central and perihilar distribution favors cardiac congestion .
Associated findings on HRCT like enlarged cardiac silhouette, pleural and pericardial effusions help suggest the diagnosis of cardiac congestion over idiopathic interstitial pneumonia .
Integrating clinical data on risk factors for heart failure, echocardiography findings and follow-up imaging response to diuretic therapy can help differentiate the two conditions when HRCT is non-specific
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- prospective observational study design. Inclusion of patients who underwent HRCT for suspected interstitial lung disease or cardiac congestion. HRCT scans by experienced radiologists who are blinded to the initial interpretation and final diagnosis. Development of specific diagnostic criteria or guidelines to differentiate between interstitial lung disease and cardiac congestion based on HRCT findings. Collection of echocardiogram,lab results, clinical follow up to determine finial diagnosis. Comparison of Initial HRCT Interpretation: Comparison of the initial HRCT interpretation with the final diagnosis to determine the rate of misdiagnosis.
Key inclusion criteria (4 listed)
- Patients who underwent HRCT imaging of the chest for evaluation of suspected interstitial lung disease
- Initial radiology report included a definitive diagnosis of interstitial lung disease patterns
- Age 18+ years
- No prior history of pulmonary or cardiac
Key exclusion criteria (2 listed)
- Inconclusive or unclear initial HRCT report
- Underlying diagnosis other than interstitial lung disease or cardiac congestion
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
Accuracy of initial HRCT interpretation
Time frame: baseline
(percentage of cases initially read as interstitial lung disease that were later found to be cardiac congestion)
1 secondary outcome
Time to correct diagnosis
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Background: PubMed 33121391Nathan SD, Pastre J, Ksovreli I, Barnett S, King C, Aryal S, Ahmad K, Fukuda C, Ramalingam V, Chung JH. HRCT evaluation of patients with interstitial lung disease: comparison of the 2018 and 2011 diagnostic guidelines. Ther Adv Respir Dis. 2020 Jan-Dec;14:1753466620968496. doi: 10.1177/1753466620968496.
- Background: PubMed 38007235Case AH, Beegle S, Hotchkin DL, Kaelin T, Kim HJ, Podolanczuk AJ, Ramaswamy M, Remolina C, Salvatore MM, Tu C, de Andrade JA. Defining the pathway to timely diagnosis and treatment of interstitial lung disease: a US Delphi survey. BMJ Open Respir Res. 2023 Nov 24;10(1):e001594. doi: 10.1136/bmjresp-2022-001594.
- 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.
marwan sayed, MD study chair
lecture in cardiac diseases
samaa elkossi, MD study chair
Lecture inradiology departement
Questions about this trial
What is this clinical trial studying?
An observational study of ILD, run by Assiut University.
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 2 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: status not confirmed, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hend saleh, MD (01098988712, hend.m.saleh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of initial HRCT interpretation (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06198608, which also lists 2 linked publications.
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 10 Jan 2024.