Thoracic Aortic AneurysmMOTAARNCT05395598
Incidence of Major Complication in Case of Thoracic Aortic Aneurysm
An observational study of Thoracic Aortic Aneurysm, run by University Hospital, Lille at 1 site in France.
Trial summary
Thoracic aneurysm is a silent disease with a potential mid-term high risk of death or major complications. Few data are available on the real incidence of major complications in case of small and moderate thoracic aneurysm. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Thoracic Aortic Aneurysm
- How many people
- 320 participants
- Where
- 1 siteFrance
- Study dates
- 18 Apr 2024to Oct 2031
- Phase
- Observational
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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with moderate thoracic aortic aneurysms for primary prevention
Who may be able to join
- Documentation of an aortic root aneurysm > 40 mm
- Agreement to participate to a longitudinal study and available for a 5 years follow-up
Who cannot join
- Presence of comorbidities or pathology with a prognosis of less than 1 year
- Personal or family history of genetically documented elastic tissue disease or patient meeting the GAND clinical criteria suggestive of Marfan disease
- High-grade mitra-aortic valve disease, even if asymptomatic
- Unbalanced hypertension ≥ 180/110 mmHg
- Aneurysm (regardless of thoracic or abdominal location) ≥ 50 mm
- Aneurysm (regardless of thoracic or abdominal location) with documented progression of more than 5 mm over one year
- History of aortic surgery or endovascular intervention and history of type B aortic dissection of medical treatment
- Renal insufficiency on dialysis, or GFR< 30 ml/mn (CKD-EPI)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Lille
Lille, Please Choose..., 59037
DELSART Pascal, +33320444365, Pascal.DELSART@chru-Lille.fr
About this study
Official title: Predicting Moderate Thoracic Aortic Aneurysm Evolution: a Longitudinal Study of Systemic Factors in Patients Free of Connective Tissue Disease. .
Thoracic aneurysm is a silent disease with a potential mid-term high risk of death or major complications. Few data are available on the real incidence of major complications in case of small and moderate thoracic aneurysm. Different factors are supposed to increase the risk of aortic enlargement as high blood pressure and sleep disorder breathing. The modality of imaging and clinical follow-up are well defined. In this prospective observational study, the aim to assess the incidence of of major complications during follow-up in a population of patients with a small or moderate thoracic aneurysm. The study will also try to identify systemic factors influencing aneurysm evolution.
- Conditions
- Thoracic Aortic Aneurysm
- Keywords
- Thoracic aortic aneurysm, Incidence, nocturnal hypertension, Sleep apnea
- Medical subject headings
- Aortic Aneurysm, Thoracic, Sleep Apnea Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence within 5 years of inclusion of a major aortic even
This composite end point is defined as the occurrence of:
- Aneurysm-related death
- Emergency surgery for threatened aortic rupture or aortic dissection
- Scheduled surgery for aneurysmal dilatation of more than 5 mm over 1 year
- Aneurysm progression exceeding 55 mm in diameter
- Root surgery for management of symptomatic aortic valve disease (insufficiency or narrowing) of high grade defined by tight aortic narrowing (V Max≥4 m/s, mean gradient ≥40mmHg, and area ≤1cm² or severe aortic insufficiency (regurgitated volume≥60 ml, shortening fraction≥ 50%.
Measured: during the 5 years after inclusion
Secondary outcomes (3)
Number of Participants with controlled blood pressure defined by ambulatory blood pressure measurement
The blood pressure measurement (averaged over 24 h)<130/80 mmHg and nocturnal blood pressure ≤120/70 mmHg
Measured: during the 2 years after inclusion
Presence of sleep disorders defined by an 'Apnea Hypopnea Index and/or an Oxygen Desaturation Index
for Apnea Hypopnea Index = ≥5 events per hour for Oxygen Desaturation Index = ≥5 events per hour
Measured: during the 2 years after inclusion
Occurrence during the 5 years after inclusion of a major cardiovascular event
This composite criterion is defined by the occurrence of death from cardiovascular causes, myocardial infarction, stroke (ischemic or hemorrhagic), or hospitalization for heart failure
Measured: during the 5 years after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start18 Apr 2024
- Primary completion18 Apr 2031 (estimated)
- Study completionOct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Aortic AneurysmStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Santelys Association, Région Nord-Pas de Calais, France, Association de Cardiologie Nord-Pas de Calais
- Responsible party
- Sponsor
- Investigators
- Pascal DELSART, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05395598
- Sponsor's protocol ID
- 2021_0151
- Other IDs
- 2022-A00439-34
- Acronym
- MOTAAR
- Status last verified
- May 2026
- First submitted
- 24 May 2022
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No