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

This study has been withdrawn prior to enrollment.
(Decided not tostart study because of unavailability of staff)
Sponsor:
Information provided by (Responsible Party):
Echosense Ltd.
ClinicalTrials.gov Identifier:
NCT01744210
First received: December 2, 2012
Last updated: June 24, 2014
Last verified: August 2012
  Purpose

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
Congestive Heart Failure (CHF)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Pulmonary Blood Flow Patterns Using Transthoracic Doppler in Patients With Congestive Heart Failure

Resource links provided by NLM:


Further study details as provided by Echosense Ltd.:

Primary Outcome Measures:
  • Diagnose specific patterns of doppler signals in CHF patients [ Time Frame: December 2013 ] [ Designated as safety issue: No ]
    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.


Enrollment: 0
Study Start Date: September 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

CHF patients admitted to the cardiology telemetry unit and to the CCU

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01744210

Locations
United States, New York
NSLIJ Lenox Hill hospital, 100East 77 Street
New-York, New York, United States, 10075
Sponsors and Collaborators
Echosense Ltd.
Investigators
Study Director: Jennifer Chen, MD Lenox Hill Hospital, 100East 77 Street New York, NY 10075
  More Information

No publications provided

Responsible Party: Echosense Ltd.
ClinicalTrials.gov Identifier: NCT01744210     History of Changes
Other Study ID Numbers: DOP081412
Study First Received: December 2, 2012
Last Updated: June 24, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 24, 2014