Annexin Imaging in Dissection of the Descending Aorta

NCT ID: NCT03832582

Last Updated: 2019-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Dissection of Thoracic Aorta (Disorder)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Annexin

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

Group Type EXPERIMENTAL

Annexin

Intervention Type DRUG

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

Interventions

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Annexin

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

Intervention Type DRUG

Other Intervention Names

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Annexin scintigraphy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier Milleron, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Service de Cardiologie - Hôpital Bichat Claude Bernard

Paris, , France

Site Status

Countries

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France

Central Contacts

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Olivier Milleron, MD

Role: CONTACT

00 33 1 40 25 68 16

Facility Contacts

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Olivier Milleron, MD

Role: primary

00 33 1 40 25 68 16

Other Identifiers

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P1700905J

Identifier Type: -

Identifier Source: org_study_id

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