Aortic Intramural HematomaNCT03424785
Long Term Clinical Implications in Chinese Patients With Aortic Intramural Hematoma
An observational study of Aortic Intramural Hematoma, run by Shenyang Northern Hospital.
Trial summary
The study evaluates outcomes of intramural hematomas after long-term follow up and establish predictive factors in Chinese population. Read more about this study
- Who is it for?
- Ages 30 to 87 years
- Conditions the study is for
- Aortic Intramural Hematoma
- What is being tested?
- drug, stent, surgical treatment
- How many people
- 270 participants
- Where
- No sites listed yet
- Study dates
- 3 Jun 2008to 14 May 2017
- 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 30 to 87 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From February 2003 to May 2017, 1770 consecutive patients were diagnosed with AAS at the General Hospital of Shenyang Military Region, including 270 IMH patients, of which 123 patients were retrospectively examined. Thirty-nine patients presented with type A aortic IMH, and 84 presented with type B aortic IMH
Who may be able to join
- Type A aortic hematoma
- Type B aortic hematoma
Who cannot join
- Aortic without initial intimal flap formation.
About this study
Official title: Long Term Follow-up and Clinical Implications in Chinese Patients With Aortic Intramural Hematoma
The study evaluates outcomes of intramural hematomas after long-term follow up and establish predictive factors in Chinese population.
Read the detailed description
270 intramural hematoma patients with clinical and imaging follow up were retrospectively studied in present study. The primary endpoint was consisted of aortic disease-related death, aortic dissection, penetrating atherosclerotic aortic ulcer , thickening of aorta hematoma and aortic complications requiring surgical or endovascular treatment.
- Conditions
- Aortic Intramural Hematoma
- Being tested
- drug, stent, surgical treatment
- Keywords
- Aortic intramural hematoma, Chinese patients, Clinical outcomes
- Medical subject headings
- Aortic Intramural Hematoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drug, stent, surgical treatmentOther
drug, stent, surgical treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
hematoma thickness and a baseline MAD
Medication and short-term imaging are recommended for Chinese IMH patients with a hematoma thickness less than 10.45 mm and a baseline MAD less than 44.75 mm. Rigorous medical observation should also be performed during the acute phase of IMH.
Measured: 14years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start3 Jun 2008
- Primary completion14 May 2017
- Study completion14 May 2017
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 Intramural HematomaStudies 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
- Retrospective
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenyang Northern Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Yaling, MD, Shenyang Northern Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03424785
- Sponsor's protocol ID
- SYNH-20171115
- Status last verified
- Dec 2017
- First submitted
- 11 Dec 2017
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Harris KM, Braverman AC, Eagle KA, Woznicki EM, Pyeritz RE, Myrmel T, Peterson MD, Voehringer M, Fattori R, Januzzi JL, Gilon D, Montgomery DG, Nienaber CA, Trimarchi S, Isselbacher EM, Evangelista A. Acute aortic intramural hematoma: an analysis from the International Registry of Acute Aortic Dissection. Circulation. 2012 Sep 11;126(11 Suppl 1):S91-6. doi: 10.1161/CIRCULATIONAHA.111.084541.
PubMed 22965999
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow-up and Clinical Implications in Chinese Patients With Aortic Intramural Hematoma
- ClinicalTrials.gov ID
- NCT03424785
- Acronym / sponsor ID
- SYNH-20171115
- Conditions
- Aortic Intramural Hematoma
- Keywords
- Aortic intramural hematoma, Chinese patients, Clinical outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Shenyang Northern HospitalUniversity, hospital or other
- Study start
- 3 Jun 2008 (actual)
- Primary completion
- 14 May 2017 (actual)
- Study completion
- 14 May 2017 (actual)
- First posted
- 7 Feb 2018 (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.
The study evaluates outcomes of intramural hematomas after long-term follow up and establish predictive factors in Chinese population.
Detailed description
270 intramural hematoma patients with clinical and imaging follow up were retrospectively studied in present study. The primary endpoint was consisted of aortic disease-related death, aortic dissection, penetrating atherosclerotic aortic ulcer , thickening of aorta hematoma and aortic complications requiring surgical or endovascular treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 30 to 87 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From February 2003 to May 2017, 1770 consecutive patients were diagnosed with AAS at the General Hospital of Shenyang Military Region, including 270 IMH patients, of which 123 patients were retrospectively examined. Thirty-nine patients presented with type A aortic IMH, and 84 presented with type B aortic IMH
Key inclusion criteria (2 listed)
- Type A aortic hematoma
- Type B aortic hematoma
Key exclusion criteria (1 listed)
- Aortic without initial intimal flap formation.
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 |
|---|---|---|
| drug, stent, surgical treatmentdrug, stent, surgical treatment | Other | – |
Primary outcome
hematoma thickness and a baseline MAD
Time frame: 14years
Medication and short-term imaging are recommended for Chinese IMH patients with a hematoma thickness less than 10.45 mm and a baseline MAD less than 44.75 mm. Rigorous medical observation should also be performed during the acute phase of IMH.
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 7 Feb 2018.
- Results publication: PubMed 22965999Harris KM, Braverman AC, Eagle KA, Woznicki EM, Pyeritz RE, Myrmel T, Peterson MD, Voehringer M, Fattori R, Januzzi JL, Gilon D, Montgomery DG, Nienaber CA, Trimarchi S, Isselbacher EM, Evangelista A. Acute aortic intramural hematoma: an analysis from the International Registry of Acute Aortic Dissection. Circulation. 2012 Sep 11;126(11 Suppl 1):S91-6. doi: 10.1161/CIRCULATIONAHA.111.084541.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Intramural Hematoma, run by Shenyang Northern Hospital.
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 2 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 7 Feb 2018. 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?
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?
hematoma thickness and a baseline MAD (time frame: 14years). 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 NCT03424785, 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 7 Feb 2018.