Long Term Clinical Implications in Chinese Patients With Aortic Intramural Hematoma

• Sponsor: Shenyang Northern Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03424785
• Collaborator: (none)
• Enrollment: 270
• Actual Duration (Months): 107.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Aortic Intramural Hematoma	Other: drug, stent, surgical treatment

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

• Study Type: Observational
• Actual Enrollment: 270 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Long Term Follow-up and Clinical Implications in Chinese Patients With Aortic Intramural Hematoma
• Actual Study Start Date: Jun 3, 2008
• Actual Primary Completion Date: May 14, 2017
• Actual Study Completion Date: May 14, 2017

Outcome Measures

Primary Outcome Measures

1. hematoma thickness and a baseline MAD [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 87 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Type A aortic hematoma

• Type B aortic hematoma

Exclusion Criteria:

• Aortic without initial intimal flap formation.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Shenyang Northern Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Han Yaling, MD, Long term follow-up and clinical implications in Chinese patients with aortic intramural hematoma, Shenyang Northern Hospital
• ClinicalTrials.gov Identifier: NCT03424785
• Other Study ID Numbers: SYNH-20171115
• First Posted: Feb 7, 2018
• Last Update Posted: Feb 7, 2018
• Last Verified: Dec 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Han Yaling, MD, Long term follow-up and clinical implications in Chinese patients with aortic intramural hematoma, Shenyang Northern Hospital: Aortic intramural hematoma; Chinese patients; Clinical outcomes
• Additional relevant MeSH terms: Hematoma

Study Results

No Results Posted as of Feb 7, 2018