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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
Phase
First received
Last updated
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
Health authority
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)

Study Design


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
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