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Graded TTCE for Post-Embolization PAVM Monitoring

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ClinicalTrials.gov Identifier: NCT02936349
Recruitment Status : Recruiting
First Posted : October 18, 2016
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
Current HHT guidelines recommend CT scan to detect new or recurrent PAVMs after embolotherapy. Recent studies using transthoracic contrast echocardiography (TTCE) shunt grade for PAVM screening suggest that graded TTCE can accurately predict the size of PAVMs on chest CT and their amenability to embolization. This study's purpose is to evaluate whether TTCE shunt grade can also accurately predict PAVM size and amenability to treatment in patients who are post-embolization.

Condition or disease Intervention/treatment
Hereditary Hemorrhagic Telangiectasia (HHT) Other: Transthoracic Contrast Echocardiogram

Detailed Description:
Embolization is the standard of care for pulmonary arteriovenous malformations (PAVMs) in the Hereditary Hemorrhagic Telangiectasia (HHT) population. PAVMs are abnormal connections between the veins and arteries and result in right-to-left shunting of blood within the lungs. Successful embolization results in PAVM resolution and decreases the complications associated with right-to-left shunting. Current guidelines recommend follow-up with interval chest CT scan to determine treatment success and detect new or recurrent PAVMs after embolization. This results in significant radiation exposure to the relatively young HHT population. An alternative to chest CT is graded transthoracic contrast echocardiography (TTCE), which measures the amount of right-to-left shunting within the lung and assigns a grade based on this amount. TTCE has the advantage of being radiation free compared to chest CT. To date, graded TTCE has only been studied as a screening tool for PAVMs. These studies have shown that graded TTCE is highly sensitive in detecting PAVMs and is comparable to chest CT when screening for PAVMs. Results indicate that TTCE grade can accurately predict PAVM size on chest CT and predict whether PAVMs are amenable to embolization. However, no studies have compared graded TTCE and chest CT in patients who are post-embolization and it is therefore unknown whether graded TTCE can be used in patients who have undergone PAVM embolization. The current study seeks to correlate post-embolization TTCE grade with chest CT findings to determine whether TTCE can accurately predict PAVM size and amenability to treatment in the post-embolization population.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Correlation of Graded Transthoracic Contrast Echocardiography With Chest CT Findings After Pulmonary Arteriovenous Malformation Embolization in Patients With Hereditary Hemorrhagic Telangiectasia, 2016
Actual Study Start Date : October 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2020



Intervention Details:
  • Other: Transthoracic Contrast Echocardiogram
    A transthoracic contrast echocardiogram (TTCE) is a still or moving image of the internal parts of the heart using ultrasound following the injection of microbubble contrast (agitated saline) into a vein in the arm, which then travels to the heart.


Primary Outcome Measures :
  1. Differences between TTCE shunt grade and the number of PAVMs present on most recent chest CT scan. [ Time Frame: At the time of the echocardiogram (TTCE) ]
  2. Differences between TTCE shunt grade and the size of PAVMs present on most recent [ Time Frame: At the time of the echocardiogram (TTCE) ]

Secondary Outcome Measures :
  1. Correlation between TTCE shunt grade to presence of PAVMs amenable to embolotherapy (feeding artery >2 mm) on most recent chest CT [ Time Frame: 48 hours after echocardiogram (TTCE) ]


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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals with a diagnosis of Hereditary Hemorrhagic Telangiectasia and a follow-up chest CT scan for PAVM surveillance after embolotherapy.
Criteria

Inclusion Criteria:

  • Age range 18-89 years old
  • Diagnosis of Hereditary Hemorrhagic Telangiectasia by the Curacao criteria
  • Prior diagnosis of one or more PAVMs treated by embolotherapy
  • Chest CT performed within the Penn system for surveillance of PAVMs after \ embolotherapy

Exclusion Criteria:

  • Known PAVM recurrence on most recent chest CT with feeding artery size amenable to repeat embolotherapy
  • Known history of intracardiac shunt
  • Discovery of intracardiac shunt during transthoracic contrast echocardiography

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02936349


Contacts
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Contact: Scott O Trerotola, MD (215) 615-3540 streroto@uphs.upenn.edu

Locations
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United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Scott O Trerotola, MD    215-615-3540    streroto@uphs.upenn.edu   
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Scott O Trerotola, MD University of Pennsylvania

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02936349     History of Changes
Other Study ID Numbers: 825381
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Pennsylvania:
Hereditary Hemorrhagic Telangiectasia (HHT)
Pulmonary Arteriovenous Malformation (PAVM)
Transthoracic Contrast Echocardiogram (TTCE)

Additional relevant MeSH terms:
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Telangiectasis
Arteriovenous Malformations
Telangiectasia, Hereditary Hemorrhagic
Arteriovenous Fistula
Vascular Diseases
Cardiovascular Diseases
Vascular Malformations
Cardiovascular Abnormalities
Congenital Abnormalities
Hemostatic Disorders
Hemorrhagic Disorders
Hematologic Diseases
Vascular Fistula
Fistula
Pathological Conditions, Anatomical