NCT02652689

Brief Summary

The LDS may contain information of significant diagnostic and physiological value regarding the pulmonary parenchyma and vasculature, as well as the cardio- vascular system in general. In pilot clinical studies of patients with acute decompensated heart failure (ADHF) as well as patients with Pulmonary Hypertension, LDS signals patterns unique to these conditions were identified. We believe that these newly discovered ultrasound signals might provide a non-invasive radiation-free means to diagnose and monitor patients with Pulmonary Embolism. The purpose of this study is to assess the utility of noninvasive assessment of lung Doppler signals performed via transthoracic parametric Doppler. The objective of the study is to evaluate the lung Doppler signals (LDS) in patients diagnosed with acute PE, in order to determine the potential assessment value of this non-invasive method in this potentially life threatening condition.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 12, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

February 8, 2019

Status Verified

March 1, 2017

Enrollment Period

2.7 years

First QC Date

January 5, 2016

Last Update Submit

February 7, 2019

Conditions

Pulmonary Embolism

Keywords

pulmonary embolismpulmonary diseaseLung Doppler signals

Outcome Measures

Primary Outcomes (1)

  • Identify lack of Lung Doppler signals in specific lung sections that were diagnosed obstructed by CT

    The obstructed sections will be compared with healthy lung sections

    30min

Study Arms (1)

Diagnostic ultrasound

EXPERIMENTAL

Recording Doppler ultrasound signals noninvasively from the right chest wall

Radiation: Diagnostic ultrasound radiation

Interventions

Diagnostic ultrasound radiationRADIATION

Recording Doppler ultrasound signals from the right chest wall

Diagnostic ultrasound

Eligibility Criteria

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

You may qualify if:

  • Confirmed diagnosis of acute PE on CTA

You may not qualify if:

  • Pregnant women
  • Inability to consent
  • Patients with severe chest wall deformity
  • Previously diagnosed PE
  • Pneumonia
  • Pulmonary edema
  • Pneumothorax
  • Severe COPD (gold class III, IV)
  • Hemodynamically unstable patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam

Haifa, Israel

Location

MeSH Terms

Conditions

Pulmonary EmbolismLung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Diana Gaitini, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2016

First Posted

January 12, 2016

Study Start

April 1, 2016

Primary Completion

December 1, 2018

Study Completion

January 1, 2019

Last Updated

February 8, 2019

Record last verified: 2017-03

Locations

IL(1)