Enhancement of Contrast Opacification for Echocardiographic Imaging of the Right Heart and Shunts

NCT ID: NCT02661529

Last Updated: 2017-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-07-31

Brief 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.

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

Keywords

Shunt; Echocardiogram

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Transesophageal Echocardiogram

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

Group Type: ACTIVE_COMPARATOR

Transesophageal Echocardiogram (TEE)

Intervention Type: PROCEDURE

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.

Saline/Air Mixture

Intervention Type: OTHER

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 Mixture

Intervention Type: OTHER

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.

Transthoracic Echocardiogram

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

Group Type: ACTIVE_COMPARATOR

Transthoracic Echocardiogram (TTE)

Intervention Type: PROCEDURE

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 Mixture

Intervention Type: OTHER

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 Mixture

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Saline/Air Mixture

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.

Intervention Type: OTHER

Saline/Blood Mixture

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Subjects having clinically indicated transesophageal or transthoracic echocardiogram, as ordered by their physician to detect a shunt.

Exclusion Criteria

• Unwillingness to provide consent to participate in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 105 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Garvan C. Kane, M.D., Ph.D.

M.D./Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Garvan Kane, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32532644 (View on PubMed)

Other Identifiers

15-004591

Identifier Type: -

Identifier Source: org_study_id