Acute Type A DissectionNCT02860182
Mechanical Characterization of Ascending Aorta in Patients With and Without Aortic Dissection
An observational study of Acute Type A Dissection, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Acute Type A Dissection
- What is being tested?
- measure the elastic properties of aortic wall
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with ascending aorta dissection
Who may be able to join
- Patients aged 50 to 85 years
- The information given search,
- Aortic dissection evolving for less than 15 days confirmed
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpitaux de Marseille
Marseille, 13354
Mourad BOUFI, 0491382747 ext. +33, drci@ap-hm.fr
About this study
Official title: Mechanical Characterization of Ascending Aorta in Patients With Acute Type A Dissection and in Healthy Control Group Combined to Structural and Ultrastructural Analysis of Aortic Tissue
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.
Read the detailed description
Objectives: this study aims to characterize mechanical properties of ascending aorta (AA) in patients, with and without aortic dissection.
Materials and methods : comprised an in vivo and ex vivo studies performed in 2 groups of patients : (1) patients admitted for acute type A dissection and treated with surgical procedure ; (2) healthy control group selected among patients without any ascending aorta pathology and who underwent transoesophageal echocardiography for various indications.
In vivo study : Strain, distensibility, stiffness index and pressure strain elastic modulus (Ep) were calculated from aortic diameter variation in response to pressure variation. Aortic diameters were measured using transoesophageal echocardiography.
Ex vivo study : biaxial tensile testing were performed on aortic wall samples. Dissected aortic samples were collected from patients who underwent surgical repair and healthy samples from unused donors hearts and lungs. Mechanical characterization was combined to a histological and microstructural analysis of aortic wall. The latter was conducted using multiphoton microscopy to visualize elastin and collagen fibers.
Results :
In vivo study: 22 patients in healthy control group and 13 patients in dissection group were prospectively investigated.
In vitro study : Biaxial testing was performed on 4 samples of dissected aorta and 6 samples of non dissected aorta. Anisotropic and non linear behavior of aortic tissue was shown in the 2 types of samples. Dissected tissue were stiffer than the intimal flap which was in turn stiffer than non dissected tissue.
Histological data showed that in dissection group global elastin density was lower than in control. Microstructural analysis in dissection specimens revealed a higher collagen signal in the media mainly in circumferential plane, contrasting with a roughly similar intensity between the two planes in control. This higher signal reflects higher collagen fiber density and/or thicker fibers in this tunica.
Conclusion : Both in vivo and in vitro data revealed that dissected aorta was stiffer than healthy ascending aorta. These findings has consequences on the choice of futur devices dedicated to AA
- Conditions
- Acute Type A Dissection
- Being tested
- measure the elastic properties of aortic wall
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measure the elastic properties of aortic wallOther
| Study group | Role | What they receive |
|---|---|---|
| experimental | patients with acute type A dissection Receives: 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 Receives: Other: measure the elastic properties of aortic wall |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one day
Measurement of aortic diameters
The measurement will be done by transesophageal echocardiography simultaneously to the cuff brachial artery pressure.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startJan 2014
- Primary completionJan 2016
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Type A DissectionStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02860182
- Sponsor's protocol ID
- 2013-08
- Status last verified
- Jul 2016
- First submitted
- 29 Jul 2016
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Characterization of Ascending Aorta in Patients With Acute Type A Dissection and in Healthy Control Group Combined to Structural and Ultrastructural Analysis of Aortic Tissue
- ClinicalTrials.gov ID
- NCT02860182
- Acronym / sponsor ID
- 2013-08
- Conditions
- Acute Type A Dissection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Aug 2016 (estimated)
- First posted
- 9 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objectives: this study aims to characterize mechanical properties of ascending aorta (AA) in patients, with and without aortic dissection.
Materials and methods : comprised an in vivo and ex vivo studies performed in 2 groups of patients : (1) patients admitted for acute type A dissection and treated with surgical procedure ; (2) healthy control group selected among patients without any ascending aorta pathology and who underwent transoesophageal echocardiography for various indications.
In vivo study : Strain, distensibility, stiffness index and pressure strain elastic modulus (Ep) were calculated from aortic diameter variation in response to pressure variation. Aortic diameters were measured using transoesophageal echocardiography.
Ex vivo study : biaxial tensile testing were performed on aortic wall samples. Dissected aortic samples were collected from patients who underwent surgical repair and healthy samples from unused donors hearts and lungs. Mechanical characterization was combined to a histological and microstructural analysis of aortic wall. The latter was conducted using multiphoton microscopy to visualize elastin and collagen fibers.
Results :
In vivo study: 22 patients in healthy control group and 13 patients in dissection group were prospectively investigated.
In vitro study : Biaxial testing was performed on 4 samples of dissected aorta and 6 samples of non dissected aorta. Anisotropic and non linear behavior of aortic tissue was shown in the 2 types of samples. Dissected tissue were stiffer than the intimal flap which was in turn stiffer than non dissected tissue.
Histological data showed that in dissection group global elastin density was lower than in control. Microstructural analysis in dissection specimens revealed a higher collagen signal in the media mainly in circumferential plane, contrasting with a roughly similar intensity between the two planes in control. This higher signal reflects higher collagen fiber density and/or thicker fibers in this tunica.
Conclusion : Both in vivo and in vitro data revealed that dissected aorta was stiffer than healthy ascending aorta. These findings has consequences on the choice of futur devices dedicated to AA
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | – | Other: measure the elastic properties of aortic wallpatients with acute type A dissection |
| control | – | Other: measure the elastic properties of aortic wallpatients 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 |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with ascending aorta dissection
Key inclusion criteria (3 listed)
- Patients aged 50 to 85 years
- The information given search,
- Aortic dissection evolving for less than 15 days confirmed
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measure the elastic properties of aortic wall | Other | control, experimental |
Primary outcome
measure the elastic properties of aortic wall
Time frame: one day
The distensibility, aortic strain will be measured as a function of changes of aortic diameter and pulse pressure.
Measurement of aortic diameters
Time frame: one day
The measurement will be done by transesophageal echocardiography simultaneously to the cuff brachial artery pressure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Urielle DESALBRES study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Type A Dissection, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mourad Boufi (04 91 38 27 47, drci@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure the elastic properties of aortic wall (time frame: one day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2016.