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NCT Number: NCT05395598

Incidence of Major Complication in Case of Thoracic Aortic Aneurysm

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.

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Key information

Conditions

Thoracic Aortic Aneurysm Aneurysm Aortic Aneurysm Aortic Aneurysm, Thoracic Aortic Diseases Apnea Cardiovascular Diseases Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Vascular Diseases

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Lille

Lille, Please Choose..., 59037, France

Location status: Recruiting

Location contact

DELSART Pascal

CONTACT

[email protected]

+33320444365

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Occurrence within 5 years of inclusion of a major aortic even

    Time frame: during the 5 years after inclusion

    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%.

Secondary outcomes

  1. Number of Participants with controlled blood pressure defined by ambulatory blood pressure measurement

    Time frame: during the 2 years after inclusion

    The blood pressure measurement (averaged over 24 h)<130/80 mmHg and nocturnal blood pressure ≤120/70 mmHg

  2. Presence of sleep disorders defined by an 'Apnea Hypopnea Index and/or an Oxygen Desaturation Index

    Time frame: during the 2 years after inclusion

    for Apnea Hypopnea Index = ≥5 events per hour for Oxygen Desaturation Index = ≥5 events per hour

  3. Occurrence during the 5 years after inclusion of a major cardiovascular event

    Time frame: during the 5 years after inclusion

    This composite criterion is defined by the occurrence of death from cardiovascular causes, myocardial infarction, stroke (ischemic or hemorrhagic), or hospitalization for heart failure

Study contacts

Contact information is provided by the study sponsor or research team.

Pascal DELSART, MD

CONTACT

[email protected]

0320445962 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Association de Cardiologie Nord-Pas de Calais
  • Région Nord-Pas de Calais, France
  • Santelys Association

Registry information

Official study title

Predicting Moderate Thoracic Aortic Aneurysm Evolution: a Longitudinal Study of Systemic Factors in Patients Free of Connective Tissue Disease. .

Acronym: MOTAAR

Important dates

Study start
2024
Primary completion
2031
Study completion
2031
First posted
May 27, 2022
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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