Annexin Imaging in Dissection of the Descending Aorta (PAIDDA)

Prognostic of Annexin Imaging in Dissection of the Descending Aorta

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Dissection of Thoracic Aorta (Disorder)
• Intervention / Treatment: Drug: Annexin

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 Type: Interventional
• Enrollment (Anticipated): 83
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Olivier Milleron, MD; Phone Number: 00 33 1 40 25 68 16; Email: olivier.milleron-ext@aphp.fr

Study Locations

• France
  • Paris, France, 75018
    • Service de Cardiologie - Hôpital Bichat Claude Bernard
    • Contact: Olivier Milleron, MD; Phone Number: 00 33 1 40 25 68 16; Email: olivier.milleron-ext@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Annexin; All patients will undergo a 99mTc-annexin V-128 scintigraphy (SPECT)	Drug: Annexin; All patients will undergo a 99mTc-annexin V-128 scintigraphy (SPECT); Other Names: Annexin scintigraphy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Olivier Milleron, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2019
• Primary Completion (Anticipated): May 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: September 10, 2018
• First Submitted That Met QC Criteria: February 4, 2019
• First Posted (Actual): February 6, 2019

Study Record Updates

• Last Update Posted (Actual): February 11, 2019
• Last Update Submitted That Met QC Criteria: February 8, 2019
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Aorta; Type B dissection; Descending aorta dissection; Annexin
• Other Study ID Numbers: P1700905J

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No