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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06198608
Other study ID # ILD&Cardiac patient
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 1, 2024
Est. completion date December 30, 2024

Study information

Verified date December 2023
Source Assiut University
Contact Hend saleh, MD
Phone 01098988712
Email hend.m.saleh@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. To establish diagnostic criteria or HRCT patterns that distinguish cardiac congestion from interstitial lung disease


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date December 30, 2024
Est. primary completion date November 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Accuracy of initial HRCT interpretation (percentage of cases initially read as interstitial lung disease that were later found to be cardiac congestion) baseline
Secondary Time to correct diagnosis Mean or median number of days/months between initial misdiagnosis on HRCT and reaching accurate diagnosis of cardiac congestion baseline
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