Aortic Aneurysm and DissectionNCT04431336
Young Patient With Aortic Dissection or Aneurysm: A Prospective Observational Cohort Study
An observational study of Aortic Aneurysm and Dissection, run by Chinese Medical Association.
Trial summary
Aortic dissection or aneurysm is unusual in young patients, and frequently associated with unusual presentations. However studies about this area is scarce. Besides, the treatment option is not clare. The prognosis of this cohort is also unclear. Read more about this study
- Who is it for?
- Ages 1 year to 50 years
- Conditions the study is for
- Aortic Aneurysm and Dissection
- What is being tested?
- movement
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 5 Jun 2020to 31 Dec 2021
- 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 1 year to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: young patients aged less than 50 years old and had aortic dissection or aneurysm
Who may be able to join
- young patients with aortic dissection or aneurysm
Who cannot join
- Aortic dissection or aneurysm due to traumatic
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Characters, Treatment and Prognosis of the Young Patient With Aortic Dissection or Aneurysm: A Prospective Observational Cohort Study
Aortic dissection or aneurysm is unusual in young patients, and frequently associated with unusual presentations. However studies about this area is scarce. Besides, the treatment option is not clare. The prognosis of this cohort is also unclear.
The goal of this study was to better understand the characters, treatment option and prognosis of young patient with aortic dissection or aneurysm.
Read the detailed description
To understand the clinical characteristics, treatment options and prognosis of aortic dissection or aneurysm in young people，the study plan will include young people younger (≤50 years) with aortic dissection or aneurysm from 2020.6. Then collect their clinical data and conduct follow-up studies, in order to understand younger aortic dissection or aneurysm patients.
- Conditions
- Aortic Aneurysm and Dissection
- Being tested
- movement
- Medical subject headings
- Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
movementBehavioural
movement
| Study group | Role | What they receive |
|---|---|---|
| younger aortic dissection or aneurysm patients | this is an observation cohort study about younger aortic dissection or aneurysm patients without intervention. Receives: Behavioral: movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical features of young aortic dissection and aneurysm patients
Collecting clinical data, such as basic information, blood biochemical information and imaging informatio to describe the characteristics of young people.
Measured: before December 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start5 Jun 2020 (estimated)
- Primary completion30 Nov 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
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 Aortic Aneurysm and 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Medical Association
- Sponsor type
- Research network
- Collaborators
- Changhai Hospital
- Responsible party
- Principal investigator, Zaiping Jing, Chinese Medical Association
- Investigators
- Zaiping MD Jing, Professor, Principal investigator, Vascular surgery, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04431336
- Sponsor's protocol ID
- https://orcid.org/0000-0002-04
- Status last verified
- Jun 2020
- First submitted
- 8 Jun 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Januzzi JL, Isselbacher EM, Fattori R, Cooper JV, Smith DE, Fang J, Eagle KA, Mehta RH, Nienaber CA, Pape LA; International Registry of Aortic Dissection (IRAD). Characterizing the young patient with aortic dissection: results from the International Registry of Aortic Dissection (IRAD). J Am Coll Cardiol. 2004 Feb 18;43(4):665-9. doi: 10.1016/j.jacc.2003.08.054.
PubMed 14975480
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characters, Treatment and Prognosis of the Young Patient With Aortic Dissection or Aneurysm: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT04431336
- Acronym / sponsor ID
- https://orcid.org/0000-0002-04
- Conditions
- Aortic Aneurysm and Dissection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese Medical AssociationResearch network
- Collaborators
- Changhai Hospital
- Study start
- 5 Jun 2020 (estimated)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 16 Jun 2020 (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.
Aortic dissection or aneurysm is unusual in young patients, and frequently associated with unusual presentations. However studies about this area is scarce. Besides, the treatment option is not clare. The prognosis of this cohort is also unclear.
The goal of this study was to better understand the characters, treatment option and prognosis of young patient with aortic dissection or aneurysm.
Detailed description
To understand the clinical characteristics, treatment options and prognosis of aortic dissection or aneurysm in young people，the study plan will include young people younger (≤50 years) with aortic dissection or aneurysm from 2020.6. Then collect their clinical data and conduct follow-up studies, in order to understand younger aortic dissection or aneurysm patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| younger aortic dissection or aneurysm patients | – | Behavioral: movementthis is an observation cohort study about younger aortic dissection or aneurysm patients without intervention. |
Who may qualify
- Ages
- 1 year to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- young patients aged less than 50 years old and had aortic dissection or aneurysm
Key inclusion criteria (1 listed)
- young patients with aortic dissection or aneurysm
Key exclusion criteria (1 listed)
- Aortic dissection or aneurysm due to traumatic
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 |
|---|---|---|
| movementmovement | Behavioural | younger aortic dissection or aneurysm patients |
Primary outcome
Clinical features of young aortic dissection and aneurysm patients
Time frame: before December 2021
Collecting clinical data, such as basic information, blood biochemical information and imaging informatio to describe the characteristics of young people.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Background: PubMed 14975480Januzzi JL, Isselbacher EM, Fattori R, Cooper JV, Smith DE, Fang J, Eagle KA, Mehta RH, Nienaber CA, Pape LA; International Registry of Aortic Dissection (IRAD). Characterizing the young patient with aortic dissection: results from the International Registry of Aortic Dissection (IRAD). J Am Coll Cardiol. 2004 Feb 18;43(4):665-9. doi: 10.1016/j.jacc.2003.08.054.
- Characterizing the young patient with aortic dissection: results from the International Registry of Aortic Dissection (IRAD).Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Zaiping MD Jing, Professor principal investigator
Vascular surgery, Changhai Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Aneurysm and Dissection, run by Chinese Medical Association.
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 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Zaiping MD Jing, professor (02131161670, xueguanky@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical features of young aortic dissection and aneurysm patients (time frame: before December 2021). 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 NCT04431336, 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 16 Jun 2020.