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

NCT ID: NCT03030521

Last Updated: 2017-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-30

Study Completion Date

2017-02-24

Brief Summary

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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.

Detailed Description

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The mechanical test: the syringe's pressure will increase gradually to a target level, and then decrease gradually to 0 Mpa, and this process is repeated for about 60 times.

Conditions

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Aortic Dissection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

the aortic delamination test

Intervention Type 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

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.

the aortic delamination test

Intervention Type 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.

Interventions

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the aortic delamination 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* patients with aortic repair surgery.

Exclusion Criteria

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

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wuhan Asia Heart Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhenlu Zhang, MD

Role: STUDY_CHAIR

Wuhan Asia Heart Hospital

Locations

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Wuhan Asia Heart Hospital

Wuhan, , China

Site Status

Countries

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China

Other Identifiers

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2012-P-011

Identifier Type: -

Identifier Source: org_study_id