Incidence of Major Complication in Case of Thoracic Aortic Aneurysm

NCT05395598 | Recruiting

• 2 other identifiers: 2021_01512022-A00439-34
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of Participants with controlled blood pressure defined by ambulatory blood pressure measurement

  during the 2 years after inclusion

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

  during the 2 years after inclusion

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

  during the 5 years after inclusion

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with moderate thoracic aortic aneurysms for primary prevention

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Lille: lead
• Santelys Association: collaborator
• Région Nord-Pas de Calais, France: collaborator
• Association de Cardiologie Nord-Pas de Calais: collaborator

Study Sites (1)

CHU Lille

Lille, Please Choose..., 59037, France

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

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

Study Officials

• Pascal DELSART, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pascal DELSART, MD

CONTACT

0320445962; pascal.DELSART@chru-Lille.fr

Study Design

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

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: May 27, 2022
• Study Start: April 18, 2024
• Primary Completion (Estimated): April 18, 2031
• Study Completion (Estimated): October 1, 2031
• Last Updated: June 24, 2024

Record last verified: 2024-06

Locations

FR (1)