Annexin Imaging in Dissection of the Descending Aorta

Assistance Publique - Hôpitaux de Paris83 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Chronic Dissection of Thoracic Aorta (Disorder)

Interventions

AnnexinDRUG

All patients will undergo a 99mTc-annexin V-128 scintigraphy (SPECT)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Service de Cardiologie - Hôpital Bichat Claude Bernard

Paris, France

Outcomes

Primary Outcomes

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.

Time frame: 30 months

Secondary Outcomes

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.

Time frame: 30 months

Blood level of fibrinolysis markers (D dimers, plasmin/anti-plasmin complexes)

Time frame: 30 months

Blood level of thrombus procoagulant activity markers (circulating P-selectin and thrombin/anti-thrombin complexes)

Time frame: 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.

Time frame: 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)

Central Contacts

Olivier Milleron, MD

CONTACT

00 33 1 40 25 68 16 olivier.milleron-ext@aphp.fr

Data from ClinicalTrials.gov

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