Study Stopped
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Pulmonary Blood Flow Measurements in CHF Patients
Evaluation of Pulmonary Blood Flow Patterns Using Transthoracic Doppler in Patients With Congestive Heart Failure
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2012
Typical duration for all trials
1 active site
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
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 11, 2013
CompletedFirst Posted
Study publicly available on registry
April 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedJuly 15, 2015
August 1, 2012
2.6 years
April 11, 2013
July 14, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Diagnose specific patterns of doppler signals in CHF patients
December 2013
Study Arms (1)
CHF patients and Controls
CHF patients refer to Decompensated patients and Compensated patients
Eligibility Criteria
CHF patients admitted to the cardiology telemetry unit and to the CCU
You may qualify if:
- Age over 50 years
- 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.
- Signed Informed Consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Echosense Ltd.lead
Study Sites (1)
NSLIJ Lenox Hill hospital, 100East 77 Street
New York, New York, 10075, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jennifer Chen, MD
Lenox Hill Hospital, 100East 77 Street New York, NY 10075
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2013
First Posted
April 15, 2013
Study Start
September 1, 2012
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
July 15, 2015
Record last verified: 2012-08