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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

Tracking Information
First Submitted Date October 10, 2016
First Posted Date October 18, 2016
Last Update Posted Date November 14, 2018
Actual Study Start Date October 2016
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 17, 2016)
  • 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) ]
  • Differences between TTCE shunt grade and the size of PAVMs present on most recent [ Time Frame: At the time of the echocardiogram (TTCE) ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02936349 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 17, 2016)
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 Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Graded TTCE for Post-Embolization PAVM Monitoring
Official Title Correlation 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 Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Hereditary Hemorrhagic Telangiectasia (HHT)
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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 17, 2016)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2020
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Scott O Trerotola, MD (215) 615-3540 streroto@uphs.upenn.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02936349
Other Study ID Numbers 825381
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Pennsylvania
Study Sponsor University of Pennsylvania
Collaborators Not Provided
Investigators
Principal Investigator: Scott O Trerotola, MD University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date November 2018