Graves' DiseaseNCT00697528
Color Doppler Imaging of Orbital Venous Flow in Grave's Orbitopathy
An observational study of Graves' Disease and Graves' Ophthalmopathy, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Orbital Venous flow study in patients with Grave's Orbitopathy in different manifestation forms and stages, made with Color Doppler Imaging Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Graves' Disease, Graves' Ophthalmopathy
- How many people
- 66 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2007to Dec 2008
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Grave's disease within the orbital service of HCFMUSP at the Ophthalmology Department
Who may be able to join
- Clinical diagnosis of Grave's Orbitopathy with well defined disease.
Who cannot join
- Uncertain cases, with an undefined status of Grave's Ophthalmopathy.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas da Universidade São Paulo
São Paulo, São Paulo, 05403-000
About this study
Orbital Venous flow study in patients with Grave's Orbitopathy in different manifestation forms and stages, made with Color Doppler Imaging
Read the detailed description
Prospective study with Grave's patients in active and fibrotic disease, myogenic and lipogenic forms, with muscle restriction and without muscle restriction and with or without optic compressive neuropathy. Blood flow was studied with Color Doppler Imaging (CDI) in the following orbital vessels:
- Superior Ophthalmic Vein (main target of the study protocol)
- Retinal Central Vein
- Retinal Central Artery
- Ophthalmic Artery
- Conditions
- Graves' Disease, Graves' Ophthalmopathy
- Keywords
- Graves, Color Doppler Imaging, Graves' Ophthalmopathy, Orbital Venous Flow
- Medical subject headings
- Graves Disease, Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group control with healthy subjects | Healthy subjects without thyroid disease, ocular disease and previous surgery in the orbit or eye used in the study. | |
| Graves' Ophthalmopathy - fibrotic phase | Patients that are clinically inactive (CAS equal or lower than 2). This group will be subdivided in the miogenic and lipogenic groups. | |
| Graves' Ophthalmopathy - active phase | Patients that are clinically active, presenting a CAS of 4 or more points, with or without disthyroid optic neuropathy. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2008 (estimated)
- Study startJan 2007
- Primary completionDec 2008
- Study completionDec 2008
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 Graves' DiseaseStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Mário LR Monteiro, Professor, Study director, Instituto do CoracaoJoseph E Benabou, Study chair, Instituto do Coracao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00697528
- Sponsor's protocol ID
- 352/06
- Status last verified
- Jun 2008
- First submitted
- 11 Jun 2008
- Last updated
- 19 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Monteiro ML, Moritz RB, Angotti Neto H, Benabou JE. Color Doppler imaging of the superior ophthalmic vein in patients with Graves' orbitopathy before and after treatment of congestive disease. Clinics (Sao Paulo). 2011;66(8):1329-34. doi: 10.1590/s1807-59322011000800004.
PubMed 21915479
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Color Doppler Imaging of Orbital Venous Flow in Grave's Orbitopathy
- ClinicalTrials.gov ID
- NCT00697528
- Acronym / sponsor ID
- 352/06
- Conditions
- Graves' Disease, Graves' Ophthalmopathy
- Keywords
- Graves, Color Doppler Imaging, Graves' Ophthalmopathy, Orbital Venous Flow
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 16 Jun 2008 (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.
Orbital Venous flow study in patients with Grave's Orbitopathy in different manifestation forms and stages, made with Color Doppler Imaging
Detailed description
Prospective study with Grave's patients in active and fibrotic disease, myogenic and lipogenic forms, with muscle restriction and without muscle restriction and with or without optic compressive neuropathy. Blood flow was studied with Color Doppler Imaging (CDI) in the following orbital vessels:
- Superior Ophthalmic Vein (main target of the study protocol)
- Retinal Central Vein
- Retinal Central Artery
- Ophthalmic Artery
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group control with healthy subjects | – | –Healthy subjects without thyroid disease, ocular disease and previous surgery in the orbit or eye used in the study. |
| Graves' Ophthalmopathy - fibrotic phase | – | –Patients that are clinically inactive (CAS equal or lower than 2). This group will be subdivided in the miogenic and lipogenic groups. |
| Graves' Ophthalmopathy - active phase | – | –Patients that are clinically active, presenting a CAS of 4 or more points, with or without disthyroid optic neuropathy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Grave's disease within the orbital service of HCFMUSP at the Ophthalmology Department
Key inclusion criteria (1 listed)
- Clinical diagnosis of Grave's Orbitopathy with well defined disease.
Key exclusion criteria (1 listed)
- Uncertain cases, with an undefined status of Grave's Ophthalmopathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 19 Dec 2013.
- Derived from this study: PubMed 21915479Monteiro ML, Moritz RB, Angotti Neto H, Benabou JE. Color Doppler imaging of the superior ophthalmic vein in patients with Graves' orbitopathy before and after treatment of congestive disease. Clinics (Sao Paulo). 2011;66(8):1329-34. doi: 10.1590/s1807-59322011000800004.
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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.
Mário LR Monteiro, Professor study director
Instituto do Coracao
Joseph E Benabou study chair
Instituto do Coracao
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 Graves' Disease and Graves' Ophthalmopathy, run by University of Sao Paulo at 1 site in Brazil.
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 1 inclusion and 1 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 19 Dec 2013. 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 Brazil. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00697528, 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 19 Dec 2013.