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Not yet recruitingNCT06198608Updated Jan 10, 2024

Misdiagnosis Between Interstitial Lung Disease and Cardiac Patients

An observational study in ILD, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-01-10.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2024, 1 year 11 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
18 Years to 70 Years
Sex
All
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Study 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

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

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Conditions studied

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In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's planned enrollment of 80 is below the median of 157 across 929 observational studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

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

Exclusion Criteria:

  • Inconclusive or unclear initial HRCT report
  • Underlying diagnosis other than interstitial lung disease or cardiac congestion
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Accuracy of initial HRCT interpretation

    (percentage of cases initially read as interstitial lung disease that were later found to be cardiac congestion)

    Time frame: 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

    Time frame: baseline

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Study locations

No study locations are listed for this record.

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References and documents

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 33121391 ↗
  • 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. PubMed 38007235 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06198608
Lead sponsor
Assiut University
Responsible party
Hend Mohamed Sayed Mohamed (doctor, Assiut University) — Principal investigator
First posted
Jan 10, 2024
Start date
Jan 1, 2024 (estimated)
Primary completion
Nov 1, 2024 (estimated)
Completion
Dec 30, 2024 (estimated)
Last update
Jan 10, 2024

Study contacts

Hend saleh, MD
Contact
hend.m.saleh@gmail.com
01098988712
Mohamed Abdalrahman, MD
Contact
dr.mga2011@aun.edu.eg
0102660007
marwan sayed, MD
study chair · lecture in cardiac diseases
samaa elkossi, MD
study chair · Lecture inradiology departement

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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