Bidirectional Cardiovascular ShuntNCT02661529
Enhancement of Contrast Opacification for Echocardiographic Imaging of the Right Heart and Shunts
A study testing Transesophageal Echocardiogram (TEE), Transthoracic Echocardiogram (TTE) and Saline/Air Mixture in people with Bidirectional Cardiovascular Shunt, run by Mayo Clinic at 1 site in United States.
Trial summary
The study aims to answer whether the use of a mixture of blood and saline alone (limited air) provides the same degree of right-heart contrast enhancement as compared to the standard agitated saline (with air), during two types of echocardiograms. Read more about this study
- Who is it for?
- Ages 18 to 105 years
- Conditions the study is for
- Bidirectional Cardiovascular Shunt
- What is being tested?
- Transesophageal Echocardiogram (TEE), Transthoracic Echocardiogram (TTE) and Saline/Air Mixture
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Jul 2016
- 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 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects having clinically indicated transesophageal or transthoracic echocardiogram, as ordered by their physician to detect a shunt.
Who cannot join
- Unwillingness to provide consent to participate in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
The study aims to answer whether the use of a mixture of blood and saline alone (limited air) provides the same degree of right-heart contrast enhancement as compared to the standard agitated saline (with air), during two types of echocardiograms.
Read the detailed description
A cardiovascular shunt is an abnormality of the blood flow between the sides of the heart or between the systemic and pulmonary circulation. A right-to-left shunt diverts blood from the right side of the heart to the left side or from the pulmonary to the systemic circulation through an anomalous opening such as septal defect or patent ductus arteriosus. To visualize the shunt during an echocardiogram, agitated saline solution is injected intravenously to provide air microbubble contrast which opacifies (makes visible) the right heart chambers and is the standard used for the non-invasive detection of right to left intracardiac or intrapulmonary shunts. However, agitated saline has the potential risk of air microembolism. Although this type of adverse event is uncommon (<1% of strokes are related to air embolism), there have been reports in the literature of a number of small strokes/transient ischemic attacks following agitated saline injections at the time of echocardiographic studies. Mixing blood with saline substantially reduces the amount of air introduced, and this study will attempt to quantify the differences in the degree of contrast enhancement.
100 patients scheduled for either Transesophageal Echocardiogram (TEE) or Transthoracic Echocardiogram (TTE) will be studied to determine the degree of contrast enhancement, when using a Saline/Air mixture versus a Saline/Blood mixture. Fifty participants of each type of echocardiography will be studied. The standard agitated saline mixture consists of 10 milliliters of sterile saline and 0.5 milliliters of air agitated together in a syringe prior to injection. The agitated Saline/Blood mixture consists of 9 milliliters of sterile saline and 0.5 - 1 milliliter of blood and agitated together in a syringe prior to injection.
All study participants will complete the routine clinical echocardiography (either a TEE or a TTE) with peripheral injection of agitated Saline/Air mixture, via an intravenous (IV) cannula attached to a three way stop cock. Blood removed from the patient will be withdrawn through the IV into a syringe and agitated with saline and then re-injected into the patient through the same tubing. After completion of the standard clinical imaging for shunt, the Saline/Blood mixture will be infused and an image obtained for comparison.
For each study, digital images will be stored and an Investigator who does not know which treatment arm/mixture was used for a given image, will subsequently rate image quality and assign an image score using a semi-quantitative scale: 0 = poor/no right atrial opacification, 1 = average right atrial opacification, 2 = good right atrial opacification. After all images are analyzed, the scores will be compared for both TEE and TTE studies.
- Conditions
- Bidirectional Cardiovascular Shunt
- Being tested
- Transesophageal Echocardiogram (TEE), Transthoracic Echocardiogram (TTE), Saline/Air Mixture, Saline/Blood Mixture
- Keywords
- Shunt, Echocardiogram
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transesophageal Echocardiogram (TEE)Procedure or surgery
Transesophageal echocardiography (TEE) is a test that produces pictures of the heart. TEE uses high-frequency sound waves (ultrasound) to make detailed pictures of the heart and the arteries that lead to and from it. Unlike a standard echocardiogram, the echo transducer that produces the sound waves for TEE is attached to a thin tube that passes through the mouth, down the throat and into the esophagus. Because the esophagus is so close to the upper chambers of the heart, very clear images of those heart structures and valves can be obtained.
Transthoracic Echocardiogram (TTE)Procedure or surgery
An echocardiogram is a type of ultrasound test that uses high-pitched sound waves that are sent through a device called a transducer. The device picks up echoes of the sound waves as they bounce off the different parts of the heart. These echoes are turned into moving pictures of the heart that can be seen on a video screen.
Transthoracic echocardiogram (TTE) is the most common type of echocardiogram. Views of the heart are obtained by moving the transducer to different locations on the chest or abdominal wall.
Saline/Air MixtureOther
The Saline/Air mixture consists of 10 milliliters of sterile saline and 0.5 milliliters of air agitated together in a syringe prior to injection.
Saline/Blood MixtureOther
The Saline/Blood mixture consists of 9 milliliters of sterile saline and 0.5 - 1.0 milliliters of blood agitated together in a syringe prior to injection.
| Study group | Role | What they receive |
|---|---|---|
| Transesophageal Echocardiogram | Active comparator | Patients undergoing an Transesophageal Echocardiogram (TEE) for diagnostic purposes to detect a cardiac shunt abnormality, using Saline/Air Mixture and Saline/Blood Mixture for vessel contrast Receives: Procedure: Transesophageal Echocardiogram (TEE); Other: Saline/Air Mixture; Other: Saline/Blood Mixture |
| Transthoracic Echocardiogram | Active comparator | Patients undergoing an Transthoracic Echocardiogram (TTE) for diagnostic purposes to detect a cardiac shunt abnormality, using Saline/Air Mixture and Saline/Blood Mixture for vessel contrast Receives: Procedure: Transthoracic Echocardiogram (TTE); Other: Saline/Air Mixture; Other: Saline/Blood Mixture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of right atrial opacification on echocardiogram image
The degree of right atrial opacification during echocardiogram will be rated with an image score; 0: poor/no opacification, 1: average opacification, 2: good opacification
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bidirectional Cardiovascular ShuntStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Garvan C. Kane, M.D., Ph.D., Mayo Clinic
- Investigators
- Garvan Kane, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02661529
- Sponsor's protocol ID
- 15-004591
- Status last verified
- Oct 2017
- First submitted
- 29 Sep 2015
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Ali MA, Hepinstall MJ, Cassidy CS, Lane CM, Pellikka PA, Thaden JJ, Pislaru SV, Kane GC. Agitated Blood-Saline Rather Than Agitated Air-Saline for Echocardiographic Shunt Studies. J Am Soc Echocardiogr. 2020 Aug;33(8):1032-1033. doi: 10.1016/j.echo.2020.03.014. Epub 2020 Jun 10. No abstract available.
PubMed 32532644
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancement of Contrast Opacification for Echocardiographic Imaging of the Right Heart and Shunts
- ClinicalTrials.gov ID
- NCT02661529
- Acronym / sponsor ID
- 15-004591
- Conditions
- Bidirectional Cardiovascular Shunt
- Keywords
- Shunt, Echocardiogram
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 22 Jan 2016 (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.
The study aims to answer whether the use of a mixture of blood and saline alone (limited air) provides the same degree of right-heart contrast enhancement as compared to the standard agitated saline (with air), during two types of echocardiograms.
Detailed description
A cardiovascular shunt is an abnormality of the blood flow between the sides of the heart or between the systemic and pulmonary circulation. A right-to-left shunt diverts blood from the right side of the heart to the left side or from the pulmonary to the systemic circulation through an anomalous opening such as septal defect or patent ductus arteriosus. To visualize the shunt during an echocardiogram, agitated saline solution is injected intravenously to provide air microbubble contrast which opacifies (makes visible) the right heart chambers and is the standard used for the non-invasive detection of right to left intracardiac or intrapulmonary shunts. However, agitated saline has the potential risk of air microembolism. Although this type of adverse event is uncommon (<1% of strokes are related to air embolism), there have been reports in the literature of a number of small strokes/transient ischemic attacks following agitated saline injections at the time of echocardiographic studies. Mixing blood with saline substantially reduces the amount of air introduced, and this study will attempt to quantify the differences in the degree of contrast enhancement.
100 patients scheduled for either Transesophageal Echocardiogram (TEE) or Transthoracic Echocardiogram (TTE) will be studied to determine the degree of contrast enhancement, when using a Saline/Air mixture versus a Saline/Blood mixture. Fifty participants of each type of echocardiography will be studied. The standard agitated saline mixture consists of 10 milliliters of sterile saline and 0.5 milliliters of air agitated together in a syringe prior to injection. The agitated Saline/Blood mixture consists of 9 milliliters of sterile saline and 0.5 - 1 milliliter of blood and agitated together in a syringe prior to injection.
All study participants will complete the routine clinical echocardiography (either a TEE or a TTE) with peripheral injection of agitated Saline/Air mixture, via an intravenous (IV) cannula attached to a three way stop cock. Blood removed from the patient will be withdrawn through the IV into a syringe and agitated with saline and then re-injected into the patient through the same tubing. After completion of the standard clinical imaging for shunt, the Saline/Blood mixture will be infused and an image obtained for comparison.
For each study, digital images will be stored and an Investigator who does not know which treatment arm/mixture was used for a given image, will subsequently rate image quality and assign an image score using a semi-quantitative scale: 0 = poor/no right atrial opacification, 1 = average right atrial opacification, 2 = good right atrial opacification. After all images are analyzed, the scores will be compared for both TEE and TTE studies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transesophageal Echocardiogram | Active comparator | Procedure: Transesophageal Echocardiogram (TEE), Other: Saline/Air Mixture, Other: Saline/Blood MixturePatients undergoing an Transesophageal Echocardiogram (TEE) for diagnostic purposes to detect a cardiac shunt abnormality, using Saline/Air Mixture and Saline/Blood Mixture for vessel contrast |
| Transthoracic Echocardiogram | Active comparator | Procedure: Transthoracic Echocardiogram (TTE), Other: Saline/Air Mixture, Other: Saline/Blood MixturePatients undergoing an Transthoracic Echocardiogram (TTE) for diagnostic purposes to detect a cardiac shunt abnormality, using Saline/Air Mixture and Saline/Blood Mixture for vessel contrast |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects having clinically indicated transesophageal or transthoracic echocardiogram, as ordered by their physician to detect a shunt.
Key exclusion criteria (1 listed)
- Unwillingness to provide consent to participate in the study
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 |
|---|---|---|
| Transesophageal Echocardiogram (TEE)Transesophageal echocardiography (TEE) is a test that produces pictures of the heart. TEE uses high-frequency sound waves (ultrasound) to make detailed pictures of the heart and the arteries that lead to and from it. Unlike a standard echocardiogram, the echo transducer that produces the sound waves for TEE is attached to a thin tube that passes through the mouth, down the throat and into the esophagus. Because the esophagus is so close to the upper chambers of the heart, very clear images of those heart structures and valves can be obtained. | Procedure or surgery | Transesophageal Echocardiogram |
| Transthoracic Echocardiogram (TTE)An echocardiogram is a type of ultrasound test that uses high-pitched sound waves that are sent through a device called a transducer. The device picks up echoes of the sound waves as they bounce off the different parts of the heart. These echoes are turned into moving pictures of the heart that can be seen on a video screen. Transthoracic echocardiogram (TTE) is the most common type of echocardiogram. Views of the heart are obtained by moving the transducer to different locations on the chest or abdominal wall. | Procedure or surgery | Transthoracic Echocardiogram |
| Saline/Air MixtureThe Saline/Air mixture consists of 10 milliliters of sterile saline and 0.5 milliliters of air agitated together in a syringe prior to injection. | Other | Transesophageal Echocardiogram, Transthoracic Echocardiogram |
| Saline/Blood MixtureThe Saline/Blood mixture consists of 9 milliliters of sterile saline and 0.5 - 1.0 milliliters of blood agitated together in a syringe prior to injection. | Other | Transesophageal Echocardiogram, Transthoracic Echocardiogram |
Primary outcome
Degree of right atrial opacification on echocardiogram image
Time frame: Day 1
The degree of right atrial opacification during echocardiogram will be rated with an image score; 0: poor/no opacification, 1: average opacification, 2: good opacification
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 26 Oct 2017.
- Derived from this study: PubMed 32532644Ali MA, Hepinstall MJ, Cassidy CS, Lane CM, Pellikka PA, Thaden JJ, Pislaru SV, Kane GC. Agitated Blood-Saline Rather Than Agitated Air-Saline for Echocardiographic Shunt Studies. J Am Soc Echocardiogr. 2020 Aug;33(8):1032-1033. doi: 10.1016/j.echo.2020.03.014. Epub 2020 Jun 10. No abstract available.
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.
Garvan Kane, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transesophageal Echocardiogram (TEE), Transthoracic Echocardiogram (TTE) and Saline/Air Mixture in people with Bidirectional Cardiovascular Shunt, run by Mayo Clinic 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 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 26 Oct 2017. 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?
Degree of right atrial opacification on echocardiogram image (time frame: Day 1). 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 NCT02661529, which also lists 1 linked publication.
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 26 Oct 2017.