Clinical trial NCT01361139: Diagnosis of Cardio-Pulmonary Pathology Using Transthoracic Parametric Doppler (TPD)
Official title: Detection and Characterization of Cardio-Pulmonary Patho-Physiological States and Diseases by Transthoracic Parametric Doppler (TPD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Disease, Chronic Obstructive
Lung Disease, Interstitial
Asthma
Sarcoidosis
Hypertension, Pulmonary
Keywords: Chronic obstructive lung disease
Interstitial lung disease
Asthma
Sarcoidosis
Pulmonary hypertension
Ultrasound
Doppler
Lung disease diagnosis
Lead sponsor: Echosense Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Clalit Health Services, Haifa and West Galilee
First posted: 2011-05-26
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to a large hospital-affiliated community lung clinic.

Brief summary: This is a study that seeks to characterize data obtained from patients with a variety of lung diseases using ultrasound signals obtained from the lung tissue. A standard ultrasound instrument in the doppler mode (not the imaging mode used in examination of pregnant women for instance) is placed on the chest wall and the unique software the investigators have developed analyzes the signal reflected back from within the lung. On the basis of pilot studies performed previously the investigators expect to receive different signals from different diseases. The investigators seek to further characterize these signals to enable accurate diagnosis of different lung diseases using our technology.


Eligibility criteria: INCLUSION CRITERIA

Age 18 years or older Patients who are clinically suspected of having pulmonary, cardiac or Cardio-pulmonary disease preferably any one or more of the conditions listed below:

* Patients with CHF
* Patients with pulmonary hypertension with documented right heart catheterization data
* Patients with COPD in two subgroups:

  * Emphysema, (evidence of emphysema on High Resolution Computed Tomography, (HRCT) and airflow limitation of GOLD II severity who have had Carbon Monoxide Diffusing capacity, (DLCO) and Residual Volume(RV) measured, or patients without HRCT with measurements of lung volumes and diffusing capacity with Total Lung Capacity (TLC) ≥1.0 predicted, RV/TLC ≥0.4, DLCO ≤ 0.7 predicted.
  * Chronic Bronchitis (No evidence of Emphysema on HRCT and/or no evidence of air-trapping or reduced DLCO.)
* Patients with asthma according to ATS/ERS definition,
* Patients with interstitial lung disease (ILD) of any etiology including sarcoidosis diagnosed by HRCT in sub groups as follows:

  * Mild ILD (TLC 0.71-0.79 predicted, DLCO ≥ 0.71 predicted)
  * Moderate and severe ILD (TLC ≤ 0.7 predicted, DLCO ≤ 0.7 predicted)
* Signed informed consent.
* Patients with sarcoidosis without evidence of parenchymal lung disease defined as normal DLCO and/or HRCT.

EXCLUSION CRITERIA

* Patients unable to cooperate.
* Inability to assume a semi-reclining or supine position
* Patients with severe chest wall deformity

Primary outcomes:
measure: Diagnose specific pattern of the LDS signals as Power and Velocity in pulmonary diseases in comparison to controls.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Regional Pulmonary Clinic, Clalit Health Services
city: Haifa
country: Israel
facility: Regional Clinic for Pulmonary Disease, Haifa and Western Galilee, Clalit Health Services
Study officials:
affiliation: Echosense Ltd.
name: Daniel Weiler, MD
role: STUDY_DIRECTOR
affiliation: Clalit Health Services
name: Uzi Milman, MD
role: PRINCIPAL_INVESTIGATOR
References: