Incidence of Major Complication in Case of Thoracic Aortic Aneurysm (MOTAAR)

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.

Study Overview

• Status: Recruiting
• Conditions: Thoracic Aortic Aneurysm

• Study Type: Observational
• Enrollment (Estimated): 320

Contacts and Locations

• Study Contact: Name: Pascal DELSART, MD; Phone Number: +33 0320445962; Email: pascal.DELSART@chru-Lille.fr

Study Locations

• France
  • Please Choose...
    • Lille, Please Choose..., France, 59037
      • Recruiting
      • CHU Lille
      • Contact: DELSART Pascal; Phone Number: +33320444365; Email: Pascal.DELSART@chru-Lille.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with moderate thoracic aortic aneurysms for primary prevention

Description

Inclusion Criteria:

• Documentation of an aortic root aneurysm > 40 mm
• Agreement to participate to a longitudinal study and available for a 5 years follow-up

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%.	during the 5 years after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	during the 5 years after inclusion

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Santelys Association; Région Nord-Pas de Calais, France; Association de Cardiologie Nord-Pas de Calais
• Investigators: Principal Investigator: Pascal DELSART, MD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2024
• Primary Completion (Estimated): April 18, 2031
• Study Completion (Estimated): October 1, 2031

Study Registration Dates

• First Submitted: May 24, 2022
• First Submitted That Met QC Criteria: May 24, 2022
• First Posted (Actual): May 27, 2022

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Incidence; Sleep apnea; nocturnal hypertension; Thoracic aortic aneurysm
• Additional Relevant MeSH Terms: Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Aortic Diseases; Aneurysm; Aortic Aneurysm; Sleep Apnea Syndromes; Aortic Aneurysm, Thoracic
• Other Study ID Numbers: 2021_0151; 2022-A00439-34 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No