Long Term Clinical Implications in Chinese Patients With Aortic Intramural Hematoma

Aortic Intramural Hematoma Clinical Trial

Official title:

Long Term Follow-up and Clinical Implications in Chinese Patients With Aortic Intramural Hematoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03424785
• Other study ID #: SYNH-20171115
• Status: Completed
• Phase: N/A
• First received: December 11, 2017
• Last updated: February 6, 2018
• Start date: June 3, 2008
• Est. completion date: May 14, 2017

Study information

• Verified date: December 2017
• Source: Shenyang Northern Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study evaluates outcomes of intramural hematomas after long-term follow up and establish predictive factors in Chinese population.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: May 14, 2017
• Est. primary completion date: May 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 87 Years

Eligibility

Inclusion Criteria:

• Type A aortic hematoma

• Type B aortic hematoma

Exclusion Criteria:

• Aortic without initial intimal flap formation.

Related Conditions & MeSH terms

• Aortic Intramural Hematoma
• Hematoma

Intervention

Other:
• drug, stent, surgical treatment
drug, stent, surgical treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shenyang Northern Hospital

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	14years