Chronic Dissection of Thoracic Aorta (Disorder) Clinical Trial
— PAIDDAOfficial title:
Prognostic of Annexin Imaging in Dissection of the Descending Aorta
The relationship between the presence of a partial thrombus and aortic dilation after type B dissection has recently been reported. The originality lies in the idea of imaging thrombus activity to predict dilation after type B dissection. The innovative character is based on the use of annexin scintigraphy.
| Status | Not yet recruiting |
| Enrollment | 83 |
| Est. completion date | December 31, 2024 |
| Est. primary completion date | May 31, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - patient whose age is = 18 years old - any patient seen more than 6 months and less than 5 years after a dissection involving the descending aorta at Bichat Hospital, whether it is a dissection of the descending aorta alone or a dissection of the ascending aorta extended to the descending aorta - dissection of the uncomplicated descending thoracic aorta: not requiring surgery or stent implantation within the first 6 months after acute dissection - effective contraception for women of childbearing age Exclusion Criteria: - scheduled procedure for dissection of the descending aorta - contraindication to aortic CT with injection of contrast media: renal failure with creatinine clearance <30 ml/min or creatinine >200 µmol/l; allergy to contrast media - history of surgery or stent implantation in the descending thoracic aorta - pregnant or breastfeeding women - patient under guardianship or trusteeship - non affiliation to social security or CMU (beneficiary or assignee) - patient refusal to participate in the study |
| Country | Name | City | State |
|---|---|---|---|
| France | Service de Cardiologie - Hôpital Bichat Claude Bernard | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Correlation between the rate of expansion of the aortic diameter and the intensity of attachment of the annexin by the aortic wall descending | Pearson correlation coefficient between the rate of expansion of the aortic diameter measured by CT (at 6 months, 18 months and 30 months) in mm/year (at the site of maximum expansion) and the intensity of attachment of the annexin by the aortic wall descending in scintigraphy. | 30 months | |
| Secondary | Determination of the optimal threshold for annexin fixation to predict the evolution of aortic dilation (< 2 mm/year, >=2mm year) using ROC curve. | Determination of the optimal threshold for annexin fixation to predict the evolution of aortic dilation (< 2 mm/year, >=2mm year) using ROC curve. The cut-off point will be defined by the Youden index. | 30 months | |
| Secondary | Blood level of fibrinolysis markers (D dimers, plasmin/anti-plasmin complexes) | Blood level of fibrinolysis markers (D dimers, plasmin/anti-plasmin complexes) | 30 months | |
| Secondary | Blood level of thrombus procoagulant activity markers (circulating P-selectin and thrombin/anti-thrombin complexes) | Blood level of thrombus procoagulant activity markers (circulating P-selectin and thrombin/anti-thrombin complexes) | 30 months | |
| Secondary | Morphological characteristics of the wall thrombus | Morphological characteristics of the wall thrombus: no thrombus of the false lumen, partial thrombosis or total thrombosis of the false lumen. | 30 months | |
| Secondary | Determination of potential predictive clinical factors of aortic dilation rate | Determination of potential predictive clinical factors of aortic dilation rate: age, blood pressure, heart rate, sex, history of dissection, etiology (Marfan or no Marfan) | 30 months | |
| Secondary | Determination of potential predictive SPECT factors of aortic dilation rate | Determination of potential predictive SPECT factors of aortic dilation rate: anormal annexin binding, ratio of annexin binding (TBR = Target-to-Background Ratio) | 30 months | |
| Secondary | Determination of potential predictive biological factors of aortic dilation rate | Determination of potential predictive biological factors (C-Reactive Protein) of aortic dilation rate | 30 months | |
| Secondary | Determination of potential predictive morphological factors of aortic dilation rate | Determination of potential predictive morphological factors of aortic dilation rate: no thrombus, partial thrombosis or total thrombosis. | 30 months | |
| Secondary | Number of cardiovascular events | Number of cardiovascular events: cardiovascular death, dissection complications (including aortic rupture, malperfusion, emboli), aortic surgery. | 30 months | |
| Secondary | Evaluation of the tolerance of the annexin scintigraphy by collecting side effects occurence | Tolerance of the annexin scintigraphy will be assessed using a questionnaire during a phone call at day 3 to ask the patients about side effects occurrence. | 3 days |