Annexin Imaging in Dissection of the Descending Aorta

Phase 2

Not yet recruiting

• Conditions: Chronic Dissection of Thoracic Aorta (Disorder)
• Interventions: Drug: Annexin

• Registration Number: NCT03832582
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Status Verified: 2018-09
• Study First Submitted: 2018-09-10
• Study First Submitted QC: 2019-02-04
• Study First Posted: 2019-02-06
• Last Update Submitted: 2019-02-08
• Last Update Posted: 2019-02-11
• Study Start: 2019-05-01
• Primary Completion: 2024-05-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 83

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Annexin	Annexin	All patients will undergo a 99mTc-annexin V-128 scintigraphy (SPECT)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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
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 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.
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 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.
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)

Trial Locations

Locations (1)

Service de Cardiologie - Hôpital Bichat Claude Bernard; 🇫🇷 Paris, France