Stanford Type A Aortic DissectionNCT03146494
The Role of Thyroid Function in the Development and Prognosis of Stanford Type A Aortic Dissection.
An observational study of Stanford Type A Aortic Dissection, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
A total of 300 consecutive cardiac patients will receive preoperative thyroid function profile evaluation, including 150 patients with Standford type A aortic dissection (STAAD) and 150 normal human.For one thing, we will compare the two groups and study the role of thyroid function in the develoment of STAAD. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stanford Type A Aortic Dissection
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2015to 1 Sep 2017
- How long will I take part?
- 2 Years
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 300 consecutive cardiac patients will receive preoperative thyroid function profile evaluation, including 150 patients with Standford type A aortic dissection (STAAD) and 150 normal human.
Who may be able to join
- Adult patients with STAAD will underwent aortic surgery who are willing and able to give informed consent for participation in the study.
Who cannot join
- The main initial exclusion criteria included clinical evidence of sepsis or cachexia or concomitant presence of any predominant severe systemic disease.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wenjian Jiang
Beijing, Beijing Municipality, 100069
Wenjian Jiang, M.D., +8618810252631, jwj87427@126.com
About this study
A total of 300 consecutive cardiac patients will receive preoperative thyroid function profile evaluation, including 150 patients with Standford type A aortic dissection (STAAD) and 150 normal human.For one thing, we will compare the two groups and study the role of thyroid function in the develoment of STAAD. For another, we will collect all the perioperative data of the STAAD group and study the role of thyroid function in the prognosis of STAAD.
- Conditions
- Stanford Type A Aortic Dissection
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 |
|---|---|---|
| STAAD | Not described | |
| Normal | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Role of Thyroid Function in the Development of STAAD.
Patients were followed for 30-day mortality and major adverse events (MAEs) as defined by the need for rethoracotomy, occurrence of postoperative heart failure, neurologic deficit, lung failure, renal failure, or sepsis.
Measured: 30 days
The Role of Thyroid Function in the Prognosis of STAAD.
Patients were followed for 30-day mortality and major adverse events (MAEs) as defined by the need for rethoracotomy, occurrence of postoperative heart failure, neurologic deficit, lung failure, renal failure, or sepsis.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start1 May 2015
- Primary completion1 Sep 2017 (estimated)
- Study completion1 Sep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stanford Type A Aortic DissectionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146494
- Sponsor's protocol ID
- Beijing Anzhen Hospital
- Status last verified
- May 2017
- First submitted
- 7 May 2017
- Last updated
- 10 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Thyroid Function in the Development and Prognosis of Stanford Type A Aortic Dissection.
- ClinicalTrials.gov ID
- NCT03146494
- Acronym / sponsor ID
- Beijing Anzhen Hospital
- Conditions
- Stanford Type A Aortic Dissection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 1 May 2015 (actual)
- Primary completion
- 1 Sep 2017 (estimated)
- Study completion
- 1 Sep 2017 (estimated)
- First posted
- 10 May 2017 (actual)
- 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.
A total of 300 consecutive cardiac patients will receive preoperative thyroid function profile evaluation, including 150 patients with Standford type A aortic dissection (STAAD) and 150 normal human.For one thing, we will compare the two groups and study the role of thyroid function in the develoment of STAAD. For another, we will collect all the perioperative data of the STAAD group and study the role of thyroid function in the prognosis of STAAD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STAAD | – | – |
| Normal | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 300 consecutive cardiac patients will receive preoperative thyroid function profile evaluation, including 150 patients with Standford type A aortic dissection (STAAD) and 150 normal human.
Key inclusion criteria (1 listed)
- Adult patients with STAAD will underwent aortic surgery who are willing and able to give informed consent for participation in the study.
Key exclusion criteria (1 listed)
- The main initial exclusion criteria included clinical evidence of sepsis or cachexia or concomitant presence of any predominant severe systemic disease.
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
The Role of Thyroid Function in the Development of STAAD.
Time frame: 30 days
Patients were followed for 30-day mortality and major adverse events (MAEs) as defined by the need for rethoracotomy, occurrence of postoperative heart failure, neurologic deficit, lung failure, renal failure, or sepsis.
The Role of Thyroid Function in the Prognosis of STAAD.
Time frame: 30 days
Patients were followed for 30-day mortality and major adverse events (MAEs) as defined by the need for rethoracotomy, occurrence of postoperative heart failure, neurologic deficit, lung failure, renal failure, or sepsis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
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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.
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 Stanford Type A Aortic Dissection, run by Beijing Anzhen Hospital at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 10 May 2017. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenjian Jiang, M.D. (+8618810252631, jwj87427@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Role of Thyroid Function in the Development of STAAD. (time frame: 30 days). 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?
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 10 May 2017.