The Roles of Intraluminal Pressure and the Dilation of Tunica Media in the Development of Aortic Dissection

NCT03030521 | Completed DMC

• 1 other identifier: 2012-P-011
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Aortic dissection is defined as the separation of aortic medial lamellae. It is unknown why some aortic dissection are limited in extent while other aortic dissection extend extensively. The investigators hypothesize that the medial layers are separated as a result of the uneven dilation and dislocation of the inner and outer layers, and if this hypothesis is ture, dilation is necessary to the development of aortic dissection. In this study, an in vitro experiment was performed to test whether dilation is essential to the development of aortic dissection. Participants will be recruited from patients with aortic repair surgery in Wuhan Asian Heart Hospital. A piece of aortic wall will be dissected to reconstruct aorta during operation. Firstly, the dissected aortic wall is sampled for routine pathological examination. Secondly, the remaining tissue is cut into a 2cm by 2cm sheet, then an incision was made on the inner surface of the tissue sheet. The outer 0.5mm media will not be incised. Thirdly, the tissue sheet is used to seal a hole in a syringe with the incision faced inside, and tissue sheet of the experimental group was bound by a band to restrict its dilation in the next step. Fourthly, the syringe is filled with blue stain, and a mechanical test is performed. Fifthly, for the experimental group, the band is removed, and the syringe is filled with red stain. The mechanical test is performed again. Finally, the tissue sheet is released and cut into several parts to show whether the inner and outer media layers are separated by the blue stain or the red stain.

Conditions

Aortic Dissection

Outcome Measures

Primary Outcomes (1)

• The number of patients with a positive result of the aortic delamination test

  whether the inner and outer media layers are separated by the blue stain or the red stain.

  1 month

Study Arms (2)

experimental group

In this group, the specimen of aortic wall is bound by a band to restrict its dilation in the fourth step of the aortic delamination test.

Diagnostic Test: the aortic delamination test

control group

In this group, the specimen of aortic wall is not bound by a band to restrict its dilation in the fourth step of the aortic delamination test.

Diagnostic Test: the aortic delamination test

Interventions

the aortic delamination test DIAGNOSTIC_TEST

The aortic delamination test will be performed in the dissected tissue of all patient. The processes of this test has been descripted in the summary.

control group; experimental group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chinese adult patients with aortic repair surgery

You may qualify if:

• patients with aortic repair surgery.

You may not qualify if:

• the dissected aortic wall is not big enough to be cut into a 2cm by 2cm sheet after routine pathological examination.

Sponsors & Collaborators

• Wuhan Asia Heart Hospital: lead

Study Sites (1)

Wuhan Asia Heart Hospital

Wuhan, 430022, China

Location

MeSH Terms

Conditions

Aortic Dissection

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Study Officials

• Zhenlu Zhang, MD

  Wuhan Asia Heart Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: January 25, 2017
• Study Start: January 30, 2017
• Primary Completion: February 24, 2017
• Study Completion: February 24, 2017
• Last Updated: February 28, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)