Long Term Clinical Implications in Chinese Patients With Aortic Intramural Hematoma

February 6, 2018 updated by: Han Yaling, MD, Shenyang Northern Hospital

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.

Study Overview

Status

Completed

Conditions

Aortic Intramural Hematoma

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

270

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 87 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

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

Description

Inclusion Criteria:

Type A aortic hematoma
Type B aortic hematoma

Exclusion Criteria:

Aortic without initial intimal flap formation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	14years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenyang Northern Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2008

Primary Completion (Actual)

May 14, 2017

Study Completion (Actual)

May 14, 2017

Study Registration Dates

First Submitted

December 11, 2017

First Submitted That Met QC Criteria

February 6, 2018

First Posted (Actual)

February 7, 2018

Study Record Updates

Last Update Posted (Actual)