Incidence of Major Complication in Case of Thoracic Aortic Aneurysm

Thoracic Aortic Aneurysm Clinical Trial

— MOTAAR  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05395598
• Other study ID #: 2021_0151
• Secondary ID: 2022-A00439-34
• Status: Not yet recruiting
• Start date: October 2022
• Est. completion date: October 2029

Study information

• Verified date: May 2022
• Source: University Hospital, Lille
• Contact: Pascal DELSART, MD
• Phone: 0320445962
• Email: pascal.DELSART[@]chru-Lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 320
• Est. completion date: October 2029
• Est. primary completion date: October 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Thoracic Aortic Aneurysm

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Lille	Association de Cardiologie Nord-Pas de Calais, Région Nord-Pas de Calais, France, Santelys Association

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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