Graded TTCE for Post-Embolization PAVM Monitoring

NCT02936349 | Completed

• 1 other identifier: 825381
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Hereditary Hemorrhagic Telangiectasia (HHT)

Keywords

Hereditary Hemorrhagic Telangiectasia (HHT); Pulmonary Arteriovenous Malformation (PAVM); Transthoracic Contrast Echocardiogram (TTCE)

Outcome Measures

Primary Outcomes (2)

• Differences between TTCE shunt grade and the number of PAVMs present on most recent chest CT scan.

  At the time of the echocardiogram (TTCE)

• Differences between TTCE shunt grade and the size of PAVMs present on most recent

  At the time of the echocardiogram (TTCE)

Secondary Outcomes (1)

• Correlation between TTCE shunt grade to presence of PAVMs amenable to embolotherapy (feeding artery >2 mm) on most recent chest CT

  48 hours after echocardiogram (TTCE)

Interventions

Transthoracic Contrast Echocardiogram OTHER

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.

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• DePietro DM, Curnes NR, Chittams J, Ferrari VA, Pyeritz RE, Trerotola SO. Postembolotherapy Pulmonary Arteriovenous Malformation Follow-Up: A Role for Graded Transthoracic Contrast Echocardiography Prior to High-Resolution Chest CT Scan. Chest. 2020 May;157(5):1278-1286. doi: 10.1016/j.chest.2019.11.023. Epub 2019 Nov 30.

  PMID: 31794700 DERIVED

MeSH Terms

Conditions

Telangiectasia, Hereditary Hemorrhagic; Pulmonary Arteriovenous Fistulas

Condition Hierarchy (Ancestors)

Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Telangiectasis; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Vascular Malformations; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Scott O Trerotola, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2016
• First Posted: October 18, 2016
• Study Start: October 1, 2016
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: November 8, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)