Mechanical Characterization of Ascending Aorta in Patients With and Without Aortic Dissection

NCT02860182 | Unknown

• 1 other identifier: 2013-08
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Acute type A aortic dissection is a frequent (3 cases per 100 000 people per year) and severe (spontaneous mortality 70%), needing an emergency surgical treatment. Surgical outcomes have improved with the development of surgical techniques, but the postoperative mortality remains high (15-30% at 30 days). Endovascular approach with the deployment of endoprosthesis sealing the proximal intimal tear is an attractive minimally invasive technique, which can represent an alternative to surgical repair especially in high risk patients.

Conditions

Acute Type A Dissection

Outcome Measures

Primary Outcomes (2)

• measure the elastic properties of aortic wall

  The distensibility, aortic strain will be measured as a function of changes of aortic diameter and pulse pressure.

  one day

• Measurement of aortic diameters

  The measurement will be done by transesophageal echocardiography simultaneously to the cuff brachial artery pressure.

  one day

Study Arms (2)

experimental

patients with acute type A dissection

Other: measure the elastic properties of aortic wall

control

patients without any pathology of the ascending aorta, but having the same characteristics as the sick patients, in terms of age and vascular risk factors including high blood pressure

Other: measure the elastic properties of aortic wall

Interventions

measure the elastic properties of aortic wall OTHER

control; experimental

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with ascending aorta dissection

You may qualify if:

• Patients aged 50 to 85 years
• The information given search,
• Aortic dissection evolving for less than 15 days confirmed

You may not qualify if:

• the acute aortic dissections against-indicated for aortic surgery (patient age, stroke or multiple organ failure)
• Iatrogenic dissections,
• Dissections related to congenital or hereditary disorder (abnormal connective tissue) or those occurring in subjects with a bicuspid aortic valve,
• Intramural hematomas type A,
• Patients under guardianship or trusteeship deprived of liberty.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

RECRUITING

Study Officials

• Urielle DESALBRES

  Assistance Publique Hôpitaux de Marseille

  STUDY DIRECTOR

Central Study Contacts

Mourad Boufi

CONTACT

04 91 38 27 47; drci@ap-hm.fr

Study Design

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

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: August 9, 2016
• Study Start: January 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 31, 2016

Record last verified: 2016-07

Locations

FR (1)