Evaluation of Blood Flow Patterns in Lung Blood Vessels Using Ultrasound Technique in Patients With Congestive Heart Failure
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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.
| Estimated Enrollment: | 200 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| 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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
CHF patients admitted to the cardiology telemetry unit and to the CCU
Inclusion Criteria:
Inclusion criteria
- 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
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| Contact: Itzhak Kronzon, MD | 212-434-6119 | ikronzon@nshs.edu |
| Contact: Jennifer Chen, MD | jchen4@nshs.edu |
| United States, New York | |
| NSLIJ Lenox Hill hospital, 100East 77 Street | Recruiting |
| New-York, New York, United States, 10075 | |
| Contact: Itzhak Kronzon, MD 212-434-6119 ikronzon@nshs.edu | |
| Principal Investigator: Itzhak Kronzon | |
| 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: | December 5, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013