Heart FailureNCT00833144
Bedside Ultrasound Identifies Congestive Heart Failure
An observational study of Heart Failure and Dyspnea, run by Emory University at 1 site in United States.
Trial summary
Patients often arrive to the Emergency Department with the chief complaint of shortness of breath. The cause of the shortness of breath may be due to many things, such as pneumonia, emphysema, a heart attack, heart failure, and others. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Dyspnea
- How many people
- 375 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Feb 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients presenting to the Emergency Care Center with the chief complaint of shortness of breath or dyspnea will be eligible for the study.
Who may be able to join
- age > 18
- presenting complaint of shortness of breath or dyspnea
Who cannot join
- prisoners
- pregnant women
- shortness of breath clearly secondary to another diagnosis (i.e. trauma)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Emergency Physician-Performed Thoracic Ultrasound Rapidly Identifies Patients With Congestive Heart Failure
Patients often arrive to the Emergency Department with the chief complaint of shortness of breath. The cause of the shortness of breath may be due to many things, such as pneumonia, emphysema, a heart attack, heart failure, and others. It is often very difficult for the physician to determine the cause of the shortness of breath in the first two hours in the Emergency Department. This ambiguity makes treating the patient very difficult. Although a patient could benefit from treatment upon arrival, the emergent treatment of the condition must wait until a final diagnosis is made.
Recently, emergency physicians have been using portable ultrasound at the patient's bedside to diagnose numerous conditions, including trauma, blood clots, kidney stones, etc. Recent research suggests that heart failure, one of the causes of shortness of breath, may be diagnosed within 5 minutes or less using ultrasound. Most of these studies come from the intensive care and cardiology. However, no research has yet been performed to determine if emergency physicians can effectively use ultrasound to quickly diagnose and treat heart failure within the first few minutes of a patient's arrival to the emergency department. The hypothesis of this study is to evaluate the ability of residents in emergency medicine to use ultrasound to diagnose patients in heart failure who presented with the chief complaint of shortness of breath. The final diagnosis of the patient upon discharge from the hospital will be compared to the preliminary diagnosis based on the portable ultrasound findings.
- Conditions
- Heart Failure, Dyspnea
- Keywords
- heart failure, dyspnea, ultrasound
- Medical subject headings
- Heart Failure, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Congestive Heart Failure | |
| 2 | Patients without congestive heart failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity and specificity of the ultrasound lung rockets to predict congestive heart failure
Measured: One year
Secondary outcomes (1)
comparison of the BNP with the thoracic ultrasound findings
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionFeb 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sierra Beck, MD, RDMS, Emory University
- Investigators
- William Manson, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833144
- Sponsor's protocol ID
- IRB00015895
- Other IDs
- 2008125
- Status last verified
- Dec 2013
- First submitted
- 29 Jan 2009
- Last updated
- 13 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Agricola E, Bove T, Oppizzi M, Marino G, Zangrillo A, Margonato A, Picano E. "Ultrasound comet-tail images": a marker of pulmonary edema: a comparative study with wedge pressure and extravascular lung water. Chest. 2005 May;127(5):1690-5. doi: 10.1378/chest.127.5.1690.
PubMed 15888847Jambrik Z, Monti S, Coppola V, Agricola E, Mottola G, Miniati M, Picano E. Usefulness of ultrasound lung comets as a nonradiologic sign of extravascular lung water. Am J Cardiol. 2004 May 15;93(10):1265-70. doi: 10.1016/j.amjcard.2004.02.012.
PubMed 15135701Lichtenstein D, Meziere G. A lung ultrasound sign allowing bedside distinction between pulmonary edema and COPD: the comet-tail artifact. Intensive Care Med. 1998 Dec;24(12):1331-4. doi: 10.1007/s001340050771.
PubMed 9885889Maisel AS, Krishnaswamy P, Nowak RM, McCord J, Hollander JE, Duc P, Omland T, Storrow AB, Abraham WT, Wu AH, Clopton P, Steg PG, Westheim A, Knudsen CW, Perez A, Kazanegra R, Herrmann HC, McCullough PA; Breathing Not Properly Multinational Study Investigators. Rapid measurement of B-type natriuretic peptide in the emergency diagnosis of heart failure. N Engl J Med. 2002 Jul 18;347(3):161-7. doi: 10.1056/NEJMoa020233.
PubMed 12124404
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Physician-Performed Thoracic Ultrasound Rapidly Identifies Patients With Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT00833144
- Acronym / sponsor ID
- IRB00015895
- Conditions
- Heart Failure, Dyspnea
- Keywords
- heart failure, dyspnea, ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 30 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients often arrive to the Emergency Department with the chief complaint of shortness of breath. The cause of the shortness of breath may be due to many things, such as pneumonia, emphysema, a heart attack, heart failure, and others. It is often very difficult for the physician to determine the cause of the shortness of breath in the first two hours in the Emergency Department. This ambiguity makes treating the patient very difficult. Although a patient could benefit from treatment upon arrival, the emergent treatment of the condition must wait until a final diagnosis is made.
Recently, emergency physicians have been using portable ultrasound at the patient's bedside to diagnose numerous conditions, including trauma, blood clots, kidney stones, etc. Recent research suggests that heart failure, one of the causes of shortness of breath, may be diagnosed within 5 minutes or less using ultrasound. Most of these studies come from the intensive care and cardiology. However, no research has yet been performed to determine if emergency physicians can effectively use ultrasound to quickly diagnose and treat heart failure within the first few minutes of a patient's arrival to the emergency department. The hypothesis of this study is to evaluate the ability of residents in emergency medicine to use ultrasound to diagnose patients in heart failure who presented with the chief complaint of shortness of breath. The final diagnosis of the patient upon discharge from the hospital will be compared to the preliminary diagnosis based on the portable ultrasound findings.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Congestive Heart Failure |
| 2 | – | –Patients without congestive heart failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the Emergency Care Center with the chief complaint of shortness of breath or dyspnea will be eligible for the study.
Key inclusion criteria (2 listed)
- age > 18
- presenting complaint of shortness of breath or dyspnea
Key exclusion criteria (3 listed)
- prisoners
- pregnant women
- shortness of breath clearly secondary to another diagnosis (i.e. trauma)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
sensitivity and specificity of the ultrasound lung rockets to predict congestive heart failure
Time frame: One year
1 secondary outcome
comparison of the BNP with the thoracic ultrasound findings
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2013.
- Background: PubMed 15888847Agricola E, Bove T, Oppizzi M, Marino G, Zangrillo A, Margonato A, Picano E. "Ultrasound comet-tail images": a marker of pulmonary edema: a comparative study with wedge pressure and extravascular lung water. Chest. 2005 May;127(5):1690-5. doi: 10.1378/chest.127.5.1690.
- Background: PubMed 15135701Jambrik Z, Monti S, Coppola V, Agricola E, Mottola G, Miniati M, Picano E. Usefulness of ultrasound lung comets as a nonradiologic sign of extravascular lung water. Am J Cardiol. 2004 May 15;93(10):1265-70. doi: 10.1016/j.amjcard.2004.02.012.
- Background: PubMed 9885889Lichtenstein D, Meziere G. A lung ultrasound sign allowing bedside distinction between pulmonary edema and COPD: the comet-tail artifact. Intensive Care Med. 1998 Dec;24(12):1331-4. doi: 10.1007/s001340050771.
- Background: PubMed 12124404Maisel AS, Krishnaswamy P, Nowak RM, McCord J, Hollander JE, Duc P, Omland T, Storrow AB, Abraham WT, Wu AH, Clopton P, Steg PG, Westheim A, Knudsen CW, Perez A, Kazanegra R, Herrmann HC, McCullough PA; Breathing Not Properly Multinational Study Investigators. Rapid measurement of B-type natriuretic peptide in the emergency diagnosis of heart failure. N Engl J Med. 2002 Jul 18;347(3):161-7. doi: 10.1056/NEJMoa020233.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Manson, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Dyspnea, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity and specificity of the ultrasound lung rockets to predict congestive heart failure (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00833144, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2013.