Clinical trial NCT03832582: Annexin Imaging in Dissection of the Descending Aorta
Official title: Prognostic of Annexin Imaging in Dissection of the Descending Aorta
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Dissection of Thoracic Aorta (Disorder)
Keywords: Aorta
Type B dissection
Descending aorta dissection
Annexin
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation between the rate of expansion of the aortic diameter and the intensity of attachment of the annexin by the aortic wall descending
timeFrame: 30 months
Secondary outcomes:
measure: Determination of the optimal threshold for annexin fixation to predict the evolution of aortic dilation (< 2 mm/year, >=2mm year) using ROC curve.
timeFrame: 30 months
measure: Blood level of fibrinolysis markers (D dimers, plasmin/anti-plasmin complexes)
timeFrame: 30 months
measure: Blood level of thrombus procoagulant activity markers (circulating P-selectin and thrombin/anti-thrombin complexes)
timeFrame: 30 months
measure: Morphological characteristics of the wall thrombus
timeFrame: 30 months
measure: Determination of potential predictive clinical factors of aortic dilation rate
timeFrame: 30 months
measure: Determination of potential predictive SPECT factors of aortic dilation rate
timeFrame: 30 months
measure: Determination of potential predictive biological factors of aortic dilation rate
timeFrame: 30 months
measure: Determination of potential predictive morphological factors of aortic dilation rate
timeFrame: 30 months
measure: Number of cardiovascular events
timeFrame: 30 months
measure: Evaluation of the tolerance of the annexin scintigraphy by collecting side effects occurence
timeFrame: 3 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de Cardiologie - Hôpital Bichat Claude Bernard
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Olivier Milleron, MD
role: PRINCIPAL_INVESTIGATOR
References: