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Evaluation of Blood Flow Patterns in Lung Blood Vessels Using Ultrasound Technique in Patients With Congestive Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01744210
Recruitment Status : Withdrawn (Decided not tostart study because of unavailability of staff)
First Posted : December 6, 2012
Last Update Posted : June 26, 2014
Information provided by (Responsible Party):
Echosense Ltd.

Brief Summary:
Historically, transthoracic Doppler echocardiography has been unable to provide interpretable data of blood flow within the lung parenchyma because of air attenuation of Doppler signals. Recently, a transthoracic Doppler system known as the Sonara/tek Transcranial Doppler (TCD) System has been developed that can identify parenchymal pulmonary blood flow (PPBF) signals. The ability to non-invasively collect information regarding the pulmonary aspect of the cardio-pulmonary system may provide valuable information and new insights into the structural and functional characteristics of the lung parenchyma and vasculature in health and disease states.

Condition or disease
Congestive Heart Failure (CHF)

Detailed Description:

This new system was previously studied among 31 healthy volunteers and one subject with atrial fibrillation.1 Pulsed spectral Doppler signals were obtained over the chest wall using a signal processing and algorithm package in conjunction with a non-imaging Doppler device coupled with an electrocardiogram. Clear reproducible lung Doppler signals (LDS) originating from different elements and phases of cardiac activity that generate mechanical waves which propagate throughout the lung were expressed in pulsatile changes in ultrasound reflections.

After the completion of the first 25 patients in our pilot study, we have received some valuable information. After assessing patients with CHF and pulmonary hypertension, we identified signals particular to the CHF group. There were unique features that were never observed in the normal patients. On top of the regular Lung Doppler signals seen in normal patients, high velocity "disorganized" variable signals that were not synchronous with the heart beat, but rather sometimes with respiration were observed. We believe that the signals may represent popping open of small bronchi surrounded by "water filled" parenchyma. These events that generate very strong reflector like signals may represent the movement of fluid at the blood vessel-alveolar air junction.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Pulmonary Blood Flow Patterns Using Transthoracic Doppler in Patients With Congestive Heart Failure
Study Start Date : September 2012
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure


Primary Outcome Measures :
  1. Diagnose specific patterns of doppler signals in CHF patients [ Time Frame: December 2013 ]
    Comparing Doppler signals' features as velocity, power, timimg, slopes and other between CHF patients and non-CHF patients. Participants will be followed up for the duration of hospital stay, usuall up to 1 week.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
CHF patients admitted to the cardiology telemetry unit and to the CCU

Inclusion Criteria:

  • Inclusion criteria

    1. Age over 50 years
    2. Belongs to one of the following categories:

      A. Decompensated CHF: patients with overt pulmonary congestion or pulmonary edema on admission, evident both clinically and by chest x-ray. Patients may be with or without a Swan-Ganz catheter.

      B. Compensated CHF: patients with significant CHF (NYHA II-IV) who are well controlled and without evidence of pulmonary congestion or pulmonary edema on admission.

      C. Non-CHF controls: patients without CHF and without any of the following: pulmonary hypertension, any known pulmonary disease, uncontrolled hypertension.

    3. Signed Informed Consent

Exclusion Criteria:

  • Chronic obstructive pulmonary disease (COPD) Asthma Interstitial lung disease Any other obstructive or restrictive lung diseases Pneumonia- currently or in the past 3 months prior to inclusion Current or past pulmonary embolism Non-cardiogenic pulmonary edema or lung injury (e.g. ARDS) Right sided pleural effusion that is not mild Severe kyphosis, scoliosis or chest wall deformity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01744210

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United States, New York
NSLIJ Lenox Hill hospital, 100East 77 Street
New-York, New York, United States, 10075
Sponsors and Collaborators
Echosense Ltd.
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Study Director: Jennifer Chen, MD Lenox Hill Hospital, 100East 77 Street New York, NY 10075
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Responsible Party: Echosense Ltd. Identifier: NCT01744210    
Other Study ID Numbers: DOP081412
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: June 26, 2014
Last Verified: August 2012
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases