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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A00439-34 | Other Identifier | ID-RCB number, ANSM |
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| Name | Class |
|---|---|
| Santelys Association | OTHER |
| Région Nord-Pas de Calais, France | OTHER |
| Association de Cardiologie Nord-Pas de Calais | UNKNOWN |
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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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| 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:
| during the 5 years after inclusion |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with moderate thoracic aortic aneurysms for primary prevention
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pascal DELSART, MD | Contact | 0320445962 | +33 | pascal.DELSART@chru-Lille.fr |
| Name | Affiliation | Role |
|---|---|---|
| Pascal DELSART, MD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Lille | Recruiting | Lille | Please Choose... | 59037 | France |
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| ID | Term |
|---|---|
| D017545 | Aortic Aneurysm, Thoracic |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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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 |
| D001018 |
| Aortic Diseases |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |