Graded TTCE for Post-Embolization PAVM Monitoring

ID: NCT02936349
Status: Recruiting
Phase: N/A
Start Date: October 01, 2016
First Submitted: October 10, 2016
Last Updated: February 15, 2018
Results: N/A
Sponsors & Collaborators: University of Pennsylvania
Location: United States
Conditions: Hereditary Hemorrhagic Telangiectasia (HHT)
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Study Description

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.

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.
Condition or disease Intervention/treatment Phase

Hereditary Hemorrhagic Telangiectasia (HHT)

Other: Transthoracic Contrast Echocardiogram
Other Names
N/A

Tracking Information

First Submitted DateOctober 10, 2016
Last Update Posted DateFebruary 15, 2018
Actual Start DateOctober 01, 2016
Anticipated Completion DateOctober 01, 2019
Actual Primary Completion DateOctober 01, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Differences between TTCE shunt grade and the size of PAVMs present on most recent [Time Frame: At the time of the echocardiogram (TTCE)]

  • 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)]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • 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)]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleGraded TTCE for Post-Embolization PAVM Monitoring
Official TitleCorrelation of Graded Transthoracic Contrast Echocardiography With Chest CT Findings After Pulmonary Arteriovenous Malformation Embolization in Patients With Hereditary Hemorrhagic Telangiectasia, 2016
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.

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.

Study TypeObservational
Study PhaseN/A
Estimated Enrollment
100
Allocation
Not Available
Interventional Model
Not Available
Masking
Not Available
Primary Purpose
Not Available
Conditions
Hereditary Hemorrhagic Telangiectasia (HHT)
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodNon-Probability Sample
Study PopulationIndividuals with a diagnosis of Hereditary Hemorrhagic Telangiectasia and a follow-up chest CT scan for PAVM surveillance after embolotherapy.
Intervention
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.

Other Names
Study Groups/Cohorts
Not Available
Study Arms
Not Available
Arm Intervention/Treatment

Recruitment Information

Recruitment Status:Recruiting
Enrollment100
Completion DateOctober 01, 2019
Eligibility 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
GenderAll
Age18 Years to 89 Years
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
United States

Administrative Information

NCT Number:NCT02936349
Other Study ID Numbers
825381
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
University of Pennsylvania
Collaborators
Not Available
Investigators
Principal Investigator
Scott O Trerotola, MD
University of Pennsylvania