NCT01744210

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

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 6, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

June 26, 2014

Status Verified

August 1, 2012

Enrollment Period

2.6 years

First QC Date

December 2, 2012

Last Update Submit

June 24, 2014

Conditions

Congestive Heart Failure (CHF)

Outcome Measures

Primary Outcomes (1)

  • Diagnose specific patterns of doppler signals in CHF patients

    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.

    December 2013

Study Arms (1)

CHF

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Study Sites (1)

NSLIJ Lenox Hill hospital, 100East 77 Street

New York, New York, 10075, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Jennifer Chen, MD

    Lenox Hill Hospital, 100East 77 Street New York, NY 10075

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2012

First Posted

December 6, 2012

Study Start

September 1, 2012

Primary Completion

April 1, 2015

Study Completion

July 1, 2015

Last Updated

June 26, 2014

Record last verified: 2012-08

Locations

US(1)