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出境医 / 临床实验 / Evaluation of the Diagnostic Value of the TPD System in Determining ADHF Causing Acute Dyspnea

Evaluation of the Diagnostic Value of the TPD System in Determining ADHF Causing Acute Dyspnea

Study Description
Brief Summary:
The objective of this study is to evaluate Lung Doppler signals (LDS) among patients presenting to the emergency department with acute dyspnea, in order to determine the diagnostic value of this non-invasive method to discriminate ADHF causing dyspnea from any other cause i.e., non-ADHF causes of dyspnea.

Condition or disease Intervention/treatment Phase
ADHF Device: Lung Doppler Signals Not Applicable

Detailed Description:

Dyspnea (shortness of breath) is a common symptom affecting as many as 25% of patients seen in ambulatory settings. It can be caused by many different underlying conditions, some of which arise acutely and can be life-threatening, making rapid clinical evaluation and targeted diagnostic studies of central importance. A number of disorders cause dyspnea, including acute decompensated heart failure (ADHF), chronic obstructive pulmonary disease (COPD), asthma, pulmonary embolism, pneumonia, metabolic acidosis, neuromuscular weakness, and others. The overlapping clinical presentations of these conditions and comorbid diseases can make the diagnostic evaluation of dyspnea a significant challenge.

Acute heart failure (AHF) is a major cause of serious morbidity and death in the general population and one of the most common medical causes of hospitalization among people aged over 60. Patients presenting to the ED with ADHF must be evaluated and treated rapidly to ensure the best possible outcomes. The diagnosis should be made as soon as possible and therapy initiated. Delayed diagnosis at presentation may also result in patients being inappropriately transferred to non-specialist wards, resulting in longer stays, increased re-admission and poorer outcomes. The key to improving the time to diagnosis depends on the clinical evaluation alongside a readiness to initiate relevant additional tests.

Previous studies showed that the TPD has the potential to differentiate between the cardiac cause of dyspnea and any other cause.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Recording Doppler US signals over the right wall chest
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Evaluation of the Diagnostic Value of the TPD System in Determining ADHF Causing Acute Dyspnea
Actual Study Start Date : September 15, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : December 2021
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. Accuracy of diagnosis [ Time Frame: Average of 1 year ]
    overall accuracy of the TPD system for the determination of ADHF causing acute dyspnea in an ED setting versus the gold standard (GS) diagnosis as determined by the final adjudicated diagnosis


Secondary Outcome Measures :
  1. Sensitivity, Specificity, PPV, NPV of TPD diagnosis [ Time Frame: Average of 1 year ]
    Calculate the analysis success parameters


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date  ICMJE June 23, 2019
First Posted Date  ICMJE June 26, 2019
Last Update Posted Date February 4, 2021
Actual Study Start Date  ICMJE September 15, 2019
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2019) 		Accuracy of diagnosis [ Time Frame: Average of 1 year ]
overall accuracy of the TPD system for the determination of ADHF causing acute dyspnea in an ED setting versus the gold standard (GS) diagnosis as determined by the final adjudicated diagnosis
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2019) 		Sensitivity, Specificity, PPV, NPV of TPD diagnosis [ Time Frame: Average of 1 year ]
Calculate the analysis success parameters
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Diagnostic Value of the TPD System in Determining ADHF Causing Acute Dyspnea
Official Title  ICMJE Evaluation of the Diagnostic Value of the TPD System in Determining ADHF Causing Acute Dyspnea
Brief Summary The objective of this study is to evaluate Lung Doppler signals (LDS) among patients presenting to the emergency department with acute dyspnea, in order to determine the diagnostic value of this non-invasive method to discriminate ADHF causing dyspnea from any other cause i.e., non-ADHF causes of dyspnea.
Detailed Description

Dyspnea (shortness of breath) is a common symptom affecting as many as 25% of patients seen in ambulatory settings. It can be caused by many different underlying conditions, some of which arise acutely and can be life-threatening, making rapid clinical evaluation and targeted diagnostic studies of central importance. A number of disorders cause dyspnea, including acute decompensated heart failure (ADHF), chronic obstructive pulmonary disease (COPD), asthma, pulmonary embolism, pneumonia, metabolic acidosis, neuromuscular weakness, and others. The overlapping clinical presentations of these conditions and comorbid diseases can make the diagnostic evaluation of dyspnea a significant challenge.

Acute heart failure (AHF) is a major cause of serious morbidity and death in the general population and one of the most common medical causes of hospitalization among people aged over 60. Patients presenting to the ED with ADHF must be evaluated and treated rapidly to ensure the best possible outcomes. The diagnosis should be made as soon as possible and therapy initiated. Delayed diagnosis at presentation may also result in patients being inappropriately transferred to non-specialist wards, resulting in longer stays, increased re-admission and poorer outcomes. The key to improving the time to diagnosis depends on the clinical evaluation alongside a readiness to initiate relevant additional tests.

Previous studies showed that the TPD has the potential to differentiate between the cardiac cause of dyspnea and any other cause.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
Recording Doppler US signals over the right wall chest
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE ADHF
Intervention  ICMJE Device: Lung Doppler Signals
Recording Doppler ultrasound on the right chest wall
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: June 25, 2019) 		600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥ 18 years
  • Patients with acute onset dyspnea (defined as shortness of breath (SOB) at rest or on exertion) and diagnostic uncertainty of etiology where heart failure is in consideration.
  • Patients designated to undergo chest X-ray as part of standard of care assessment.

Exclusion Criteria:

  • Obvious trauma contributing to dyspnea
  • Inability to provide written informed consent
  • Not speaking English or Spanish
  • Right-sided lobectomy
  • Patients with implanted ventricular assist device
  • Patient is unable to undergo the TPD test
  • Patient is already enrolled in a clinical study with experimental medications
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03998410
Other Study ID Numbers  ICMJE DOP-27
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Echosense Ltd.
Study Sponsor  ICMJE Echosense Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Judd Hollander, MD judd.hollander@jefferson.edu
PRS Account Echosense Ltd.
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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