NCT06198608

Brief 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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

January 10, 2024

Status Verified

December 1, 2023

Enrollment Period

10 months

First QC Date

December 26, 2023

Last Update Submit

January 8, 2024

Conditions

Outcome Measures

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)

    baseline

Secondary Outcomes (1)

  • Time to correct diagnosis

    baseline

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 33121391BACKGROUND
  • 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.

    PMID: 38007235BACKGROUND

Study Officials

  • marwan sayed, MD

    lecture in cardiac diseases

    STUDY CHAIR
  • samaa elkossi, MD

    Lecture inradiology departement

    STUDY CHAIR

Central Study Contacts

Mohamed Abdalrahman, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

December 26, 2023

First Posted

January 10, 2024

Study Start

January 1, 2024

Primary Completion

November 1, 2024

Study Completion

December 30, 2024

Last Updated

January 10, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share