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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Annexin | Experimental | All patients will undergo a 99mTc-annexin V-128 scintigraphy (SPECT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Annexin | Drug | All patients will undergo a 99mTc-annexin V-128 scintigraphy (SPECT) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olivier Milleron, MD | Contact | 00 33 1 40 25 68 16 | olivier.milleron-ext@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Olivier Milleron, MD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Cardiologie - Hôpital Bichat Claude Bernard | Paris | 75018 | France |
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| ID | Term |
|---|---|
| D000094629 | Dissection, Thoracic Aorta |
| ID | Term |
|---|---|
| D000784 | Aortic Dissection |
| D000094665 | Dissection, Blood Vessel |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D017302 | Annexins |
| ID | Term |
|---|---|
| D002135 | Calcium-Binding Proteins |
| D002352 | Carrier Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| 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 |
| D002318 |
| Cardiovascular Diseases |
| D000094683 | Acute Aortic Syndrome |
| D001018 | Aortic Diseases |