Misdiagnosis Between Interstitial Lung Disease and Cardiac Patients

January 8, 2024 updated by: Hend Mohamed Sayed Mohamed, Assiut University

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

Not yet recruiting

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

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: marwan sayed, MD, lecture in cardiac diseases
  • Study Chair: samaa elkossi, MD, Lecture inradiology departement

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

December 26, 2023

First Submitted That Met QC Criteria

January 8, 2024

First Posted (Actual)

January 10, 2024

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • ILD&Cardiac patient

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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