Annexin Imaging in Dissection of the Descending Aorta

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prognostic of Annexin Imaging in Dissection of the Descending Aorta

Conditions
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Chronic Dissection of Thoracic Aorta (Disorder)

Intervention / Treatment
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* Drug: Annexin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Annexin<br>All patients will undergo a 99mTc-annexin V-128 scintigraphy (SPECT) | Drug: Annexin<br>* All patients will undergo a 99mTc-annexin V-128 scintigraphy (SPECT)<br>* Other names: Annexin scintigraphy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Blood level of fibrinolysis markers (D dimers, plasmin/anti-plasmin complexes) | Blood level of fibrinolysis markers (D dimers, plasmin/anti-plasmin complexes) | 30 months | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Number of cardiovascular events | Number of cardiovascular events: cardiovascular death, dissection complications (including aortic rupture, malperfusion, emboli), aortic surgery. | 30 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aorta, Type B dissection, Descending aorta dissection, Annexin