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Assessment of Radiolabeled rhAnnexin V-128 in Infective Endocarditis (AnnIE)

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ClinicalTrials.gov Identifier: NCT02459613
Recruitment Status : Unknown
Verified July 2016 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was:  Recruiting
First Posted : June 2, 2015
Last Update Posted : July 14, 2016
Sponsor:
Collaborator:
Advanced Accelerator Applications
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Brief Summary:

Intraluminal thrombi adherent to cardiac valves or atria share a common pathophysiology involving the aggregation of activated platelets with phosphatidylserine (PS) expression on the outer layer of the thrombus. They also share common complications, i.e. damages to the underlying myocardium and embolic risk related to thrombus fragmentation. The diagnostic work-up, currently relying on morphologic imaging alone (mainly echography), lacks sensitivity and does not allow to differentiate between active (renewal and growth activity) and quiescent (scarred) thrombus. It is therefore highly desirable to develop a new approach able to non-invasively provide insight on the biological activity of thrombi and to detect embolic events in a single exam.

Annexin V is a 36 kDa endogenous glycoprotein which binds PS with nanomolar affinity. Radiolabeled Annexin V has been shown to provide molecular imaging of PS expressed by apoptotic cells or activated platelets. The ability of the imaging agent to bind mural thrombus has been established in vivo in a murine model of abdominal aortic aneurysm and ex vivo in human. It has been also shown that radiolabeled Annexin V allowed in vivo detection of vegetations and secondary pulmonary emboli with high sensitivity in various animal models of infective endocarditis.

A radiolabeling kit of annexin V complying with GMP requirements has been developed (rhAnnexine V-128, Advanced Accelerator Applications - Atreus) and is currently available. AnniE is a single centre, proof of concept, interventional, open, non-randomized study aiming at evaluating the sensitivity of 99mTc-Annexin V-128 in the detection thrombus in comparison with reference imaging in patients presenting with either: 1/ infective endocarditis or 2/ atrial thrombus. The safety of the 99mTc-Annexin V-128 will be assessed in a first phase (10 first patients enrolled). Data in relation with safety of the imaging agent will be reviewed by an independent Data and Safety Monitoring Board (DSMB); in case of positive answer, the study will continue with a second phase. The data gathered in all patients (n=120) will be used to determine outcome measures.


Condition or disease Intervention/treatment Phase
Endocarditis Thrombosis Other: 99mTc-Annexin V-128 SPECT Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation de la rhAnnexine V-128 radiomarquée Dans le Diagnostic de l'Endocardite Infectieuse, du Thrombus Atrial et de Leurs Complications Emboliques associées
Study Start Date : January 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Imaging
99mTc Annexin V-128 SPECT
Other: 99mTc-Annexin V-128 SPECT



Primary Outcome Measures :
  1. Diagnostic sensitivity in infective endocarditis and atrial thrombus [ Time Frame: up to 4 weeks ]

Secondary Outcome Measures :
  1. Diagnostic value (sensitivity and specificity) in infective endocarditis [ Time Frame: up to 4 weeks ]
  2. Diagnostic sensitivity in atrial thrombus [ Time Frame: up to 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • stable clinical status
  • signed informed consent
  • contraception in women of childhood potential

    • Endocarditis group:
  • definite ou possible endocarditis (modified Duke criteria)

    • Atrial thrombosis group:
  • presence of atrial thrombosis evidenced by transesophageal echocardiography

Exclusion Criteria:

  • pregnant or lactating women
  • contra-indication to both MRI and CT

    • Endocarditis group:
  • history of cardiac surgery in relation with the current episode
  • (effective) antibiotic regimen for more than 15 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02459613


Contacts
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Contact: Francois Rouzet, MD, PhD +33140256411 francois.rouzet@bch.aphp.fr

Locations
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France
Bichat Hospital Recruiting
Paris, France, 75018
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Advanced Accelerator Applications
Investigators
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Principal Investigator: Dominique Le Guludec, MD, PhD Assistance Publique - Hôpitaux de Paris

Publications:
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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT02459613     History of Changes
Other Study ID Numbers: C13-38
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016
Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Radionuclide imaging
Annexin
Additional relevant MeSH terms:
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Thrombosis
Endocarditis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Annexin A5
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action