Pulmonary Arterial HypertensionNCT02028299
Estimation of Pulmonary Vascular Resistance by Contrast Echocardiography
A study testing 2D doppler echo with Definity solution in people with Pulmonary Arterial Hypertension, run by George Washington University.
Trial summary
An echocardiogram using Definity contrast can provide the same information as the standard right heart catheterization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- 2D doppler echo with Definity solution
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Jul 2012
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients scheduled to undergo right heart catheterization at the George Washington University Hospital
Who cannot join
- Patients with known or suspected right-to-left bi-directional or transient right-to-left shunts or pulmonary arteriovenous malformations, previously documented moderate to severe tricuspid regurgitation or moderate to severe pulmonary regurgitation, evidence of right ventricular hypokinesis, or prior adverse reaction to Definity or hypersensitivity to perflutren
About this study
An echocardiogram using Definity contrast can provide the same information as the standard right heart catheterization.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- 2D doppler echo with Definity solution
- Keywords
- Pulmonary Arterial Hypertension, Pulmonary Vascular Resistance, Right Heart Catheterization
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2D doppler echo with Definity solutionProcedure or surgery
Also called Definity solution
Correlate right heart catheterization results with results from 2D doppler echo with Definity Solution
| Study group | Role | What they receive |
|---|---|---|
| 2D doppler echo with Definity solution | Experimental | Study subjects will already be scheduled for right heart catheterization to diagnose pulmonary hypertension. Prior to the catheterization, each subject will have a 2D doppler echocardiogram with Definity solution as well. Receives: Procedure: 2D doppler echo with Definity solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure Pulmonary Vascular Resistance using 2D Doppler Echocardiogram w/Definity Solution
Correlation coefficients between the technique above the the gold standard right heart catheterization measures of pulmonary vascular resistance.
Measured: Two Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startApr 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by George Washington 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Choi, MD, Principal investigator, Medical Faculty Associates, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02028299
- Sponsor's protocol ID
- 060922
- Status last verified
- Apr 2013
- First submitted
- 20 Aug 2013
- Last updated
- 7 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Pulmonary Vascular Resistance by Contrast Echocardiography
- ClinicalTrials.gov ID
- NCT02028299
- Acronym / sponsor ID
- 060922
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Pulmonary Arterial Hypertension, Pulmonary Vascular Resistance, Right Heart Catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 7 Jan 2014 (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.
An echocardiogram using Definity contrast can provide the same information as the standard right heart catheterization.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2D doppler echo with Definity solution | Experimental | Procedure: 2D doppler echo with Definity solutionStudy subjects will already be scheduled for right heart catheterization to diagnose pulmonary hypertension. Prior to the catheterization, each subject will have a 2D doppler echocardiogram with Definity solution as well. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients scheduled to undergo right heart catheterization at the George Washington University Hospital
Key exclusion criteria (1 listed)
- Patients with known or suspected right-to-left bi-directional or transient right-to-left shunts or pulmonary arteriovenous malformations, previously documented moderate to severe tricuspid regurgitation or moderate to severe pulmonary regurgitation, evidence of right ventricular hypokinesis, or prior adverse reaction to Definity or hypersensitivity to perflutren
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2D doppler echo with Definity solutionAlso: Definity solutionCorrelate right heart catheterization results with results from 2D doppler echo with Definity Solution | Procedure or surgery | 2D doppler echo with Definity solution |
Primary outcome
Measure Pulmonary Vascular Resistance using 2D Doppler Echocardiogram w/Definity Solution
Time frame: Two Years
Correlation coefficients between the technique above the the gold standard right heart catheterization measures of pulmonary vascular resistance.
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 7 Jan 2014.
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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.
Brian Choi, MD principal investigator
Medical Faculty Associates, Inc.
Questions about this trial
What is this clinical trial studying?
A study testing 2D doppler echo with Definity solution in people with Pulmonary Arterial Hypertension, run by George Washington University.
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 1 inclusion and 1 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 7 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Measure Pulmonary Vascular Resistance using 2D Doppler Echocardiogram w/Definity Solution (time frame: Two Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2014.