- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06198608
Misdiagnosis Between Interstitial Lung Disease and Cardiac Patients
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
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Hend saleh, MD
- Phone Number: 01098988712
- Email: hend.m.saleh@gmail.com
Study Contact Backup
- Name: Mohamed Abdalrahman, MD
- Phone Number: 0102660007
- Email: dr.mga2011@aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Inconclusive or unclear initial HRCT report
- Underlying diagnosis other than interstitial lung disease or cardiac congestion
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to correct diagnosis
Time Frame: baseline
|
Mean or median number of days/months between initial misdiagnosis on HRCT and reaching accurate diagnosis of cardiac congestion
|
baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: marwan sayed, MD, lecture in cardiac diseases
- Study Chair: samaa elkossi, MD, Lecture inradiology departement
Publications and helpful links
General 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.
- Case 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ILD&Cardiac patient
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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