Hereditary Hemorrhagic Telangiectasia (HHT)NCT02936349
Graded TTCE for Post-Embolization PAVM Monitoring
An observational study of Hereditary Hemorrhagic Telangiectasia (HHT), run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Hereditary Hemorrhagic Telangiectasia (HHT)
- What is being tested?
- Transthoracic Contrast Echocardiogram
- Type of treatment
- Injection or infusion
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with a diagnosis of Hereditary Hemorrhagic Telangiectasia and a follow-up chest CT scan for PAVM surveillance after embolotherapy.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Correlation of Graded Transthoracic Contrast Echocardiography With Chest CT Findings After Pulmonary Arteriovenous Malformation Embolization in Patients With Hereditary Hemorrhagic Telangiectasia, 2016
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.
Read the 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.
- Being tested
- Transthoracic Contrast Echocardiogram
- Keywords
- Hereditary Hemorrhagic Telangiectasia (HHT), Pulmonary Arteriovenous Malformation (PAVM), Transthoracic Contrast Echocardiogram (TTCE)
- Medical subject headings
- Telangiectasia, Hereditary Hemorrhagic, Pulmonary Arteriovenous Fistulas
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic Contrast EchocardiogramOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences between TTCE shunt grade and the number of PAVMs present on most recent chest CT scan.
Measured: At the time of the echocardiogram (TTCE)
Differences between TTCE shunt grade and the size of PAVMs present on most recent
Measured: 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
Measured: 48 hours after echocardiogram (TTCE)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionNov 2019
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hereditary Hemorrhagic Telangiectasia (HHT)Studies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott O Trerotola, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936349
- Sponsor's protocol ID
- 825381
- Status last verified
- Nov 2019
- First submitted
- 10 Oct 2016
- Last updated
- 8 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31794700
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Graded Transthoracic Contrast Echocardiography With Chest CT Findings After Pulmonary Arteriovenous Malformation Embolization in Patients With Hereditary Hemorrhagic Telangiectasia, 2016
- ClinicalTrials.gov ID
- NCT02936349
- Acronym / sponsor ID
- 825381
- Keywords
- Hereditary Hemorrhagic Telangiectasia (HHT), Pulmonary Arteriovenous Malformation (PAVM), Transthoracic Contrast Echocardiogram (TTCE)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with a diagnosis of Hereditary Hemorrhagic Telangiectasia and a follow-up chest CT scan for PAVM surveillance after embolotherapy.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transthoracic Contrast EchocardiogramA 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 | – |
Primary outcome
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)
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
- Derived from this study: PubMed 31794700DePietro 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott O Trerotola, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hereditary Hemorrhagic Telangiectasia (HHT), run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02936349, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2019.