Chronic Dissection of Thoracic Aorta (Disorder)
Conditions
Keywords
Aorta, Type B dissection, Descending aorta dissection, Annexin
Brief summary
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.
Detailed description
To establish the proof of concept in humans of the link between the intensity of 99mTc-annexin V-128 binding in the descending thoracic aorta and the progression of aortic diameter in patients with type B aortic dissection.
Interventions
DRUGAnnexin
All patients will undergo a 99mTc-annexin V-128 scintigraphy (SPECT)
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between the rate of expansion of the aortic diameter and the intensity of attachment of the annexin by the aortic wall descending | 30 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood level of fibrinolysis markers (D dimers, plasmin/anti-plasmin complexes) | 30 months | Blood level of fibrinolysis markers (D dimers, plasmin/anti-plasmin complexes) |
| Blood level of thrombus procoagulant activity markers (circulating P-selectin and thrombin/anti-thrombin complexes) | 30 months | Blood level of thrombus procoagulant activity markers (circulating P-selectin and thrombin/anti-thrombin complexes) |
| Morphological characteristics of the wall thrombus | 30 months | Morphological characteristics of the wall thrombus: no thrombus of the false lumen, partial thrombosis or total thrombosis of the false lumen. |
| Determination of potential predictive clinical factors of aortic dilation rate | 30 months | Determination of potential predictive clinical factors of aortic dilation rate: age, blood pressure, heart rate, sex, history of dissection, etiology (Marfan or no Marfan) |
| Determination of the optimal threshold for annexin fixation to predict the evolution of aortic dilation (< 2 mm/year, >=2mm year) using ROC curve. | 30 months | 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. |
| Determination of potential predictive biological factors of aortic dilation rate | 30 months | Determination of potential predictive biological factors (C-Reactive Protein) of aortic dilation rate |
| Determination of potential predictive morphological factors of aortic dilation rate | 30 months | Determination of potential predictive morphological factors of aortic dilation rate: no thrombus, partial thrombosis or total thrombosis. |
| Number of cardiovascular events | 30 months | Number of cardiovascular events: cardiovascular death, dissection complications (including aortic rupture, malperfusion, emboli), aortic surgery. |
| Evaluation of the tolerance of the annexin scintigraphy by collecting side effects occurence | 3 days | 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. |
| Determination of potential predictive SPECT factors of aortic dilation rate | 30 months | Determination of potential predictive SPECT factors of aortic dilation rate: anormal annexin binding, ratio of annexin binding (TBR = Target-to-Background Ratio) |
Countries
France
Contacts
Primary ContactOlivier Milleron, MD
Outcome results
None listed