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99mTc-rhAnnexin V-128 Imaging for Carotid Atherosclerosis

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ClinicalTrials.gov Identifier: NCT02667457
Recruitment Status : Recruiting
First Posted : January 29, 2016
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Advanced Accelerator Applications

Brief Summary:
The study is being done to assess the ability of the radiotracer 99mTc-rhAnnexin V-128 to image atherosclerotic plaque that may rupture and break off artery walls. This is caused by apoptosis or cell death in the plaque. These ruptured plaques can block blood circulation in the arteries causing a lack of oxygen to the tissues. Atherosclerotic plaques can build up on any artery in the body.

Condition or disease Intervention/treatment Phase
Carotid Artery Plaque Radiation: 99mTc-rhAnnexin V-128 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 99mTc-rhAnnexin V-128 SPECT Imaging of Apoptosis in Asymptomatic Patients With Carotid Atherosclerotic Plaque
Study Start Date : April 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients

Patients with asymptomatic carotid atherosclerotic plaque with evidence of 50% or more carotid stenosis in one or more carotid arteries on carotid ultrasound within 2 years.

Patients will undergo carotid ultrasound and 99mTc-rhAnnexin V-128 SPECT/CT imaging.

Radiation: 99mTc-rhAnnexin V-128
Experimental: Healthy participants

Healthy participants with no significant carotid artery disease on carotid ultrasound.

Participants will undergo carotid ultrasound and 99mTc-rhAnnexin V-128 SPECT/CT imaging.

Radiation: 99mTc-rhAnnexin V-128



Primary Outcome Measures :
  1. Imaging feasibility (Proof of Concept step) [ Time Frame: Day 0 ]
    The feasibility of imaging apoptotic activity in carotid atherosclerotic plaques using 99mTc-rhAnnexin V-128 will be assessed by the data monitoring committee (visual image review and consensus). The frequency and severity of abnormal carotid scans will be determined in the patient and normal groups.

  2. Prevalence of abnormal 99mTc-rhAnnexin V-128 SPECT/CT imaging (Phase II step) [ Time Frame: Day 0 ]
    Prevalence of abnormal 99mTc-rhAnnexin V-128 SPECT/CT imaging.


Secondary Outcome Measures :
  1. Background profile of control subjects [ Time Frame: Day 0 ]
    Descriptive statistics of 99mTc-rhAnnexin V-128 uptake in control subjects will be presented by areas of interest to assess the background uptake profile

  2. Echogenecity and echolucency correlations [ Time Frame: Baseline and Day 0 ]
    99mTc-rhAnnexin V-128 carotid uptake will be related to the ultrasound data of plaque echogenicity and echolucency.

  3. Aortic uptake correlation [ Time Frame: Day 0 ]
    99mTc-rhAnnexin V-128 uptake in carotids will be correlated to aortic uptake in all participants

  4. Adverse events [ Time Frame: From enrolment up to Day 30 ]
    Type and incidence of AEs, as well as severity and relatedness to the study medication will be described

  5. Laboratory tests [ Time Frame: At Baseline and Day 30 ]
    Pattern of participants with abnormal laboratory values will be analyzed based on clinical relevance



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

For all participants:

  1. Males and females age 18 years or greater
  2. Able and willing to comply with the study procedures
  3. Negative pregnancy test for women of childbearing potential at screening and on the day of administration of 99mTc-rhAnnexin V-128.

    For participants with carotid artery disease:

  4. Evidence of 50% or more carotid stenosis in one or more carotid arteries on carotid ultrasound within 2 years;
  5. Evidence of 50% or more carotid stenosis in the most recent US imaging within 8 weeks prior to 99mTc-rhAnnexin V-128 administration

    For control participants:

  6. No significant carotid artery disease on carotid ultrasound;
  7. No clinically significant abnormalities in baseline laboratory values.

Exclusion Criteria:

  1. Previous carotid stenting or endarterectomy, stroke or transient ischemic attack;
  2. Diagnosis of vasculitis, dissection, or non-atherosclerotic carotid disease (Ehlers-Danlos, Marfans);
  3. Pregnancy or lactation;
  4. History of any disease or relevant physical or psychiatric condition or abnormal physical finding which may interfere with the study objectives at the investigator judgment;
  5. Know hypersensitivity to the investigational product or any of its components;
  6. Claustrophobia or inability to lie still in a supine position;
  7. Participation in another clinical trial within 4 weeks before study inclusion, except for patients who have participated or who are currently participating in a study without any study drug administration;
  8. Unwillingness to provide consent.

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): NCT02667457


Contacts
Contact: Terrence Ruddy, MD, FRCPC, FACC +1 613-761-4085 truddy@ottawaheart.ca

Locations
Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Terrence Ruddy, MD, FRCPC, FACC    613-761-4085    truddy@ottawaheart.ca   
Contact: Marlie Poirier, Clinical Trial Coordinator       m.poirier@ottawaheart.ca   
Principal Investigator: Terrence Ruddy, MD, FRCPC, FACC         
Sub-Investigator: Kathryn Ascah, MD, FRCPC, FACC         
Sub-Investigator: Benjamin Chow, MD, FRCPC, FACC         
Sub-Investigator: Girish Dwivedi, PhD, MD         
Sub-Investigator: Glenn Wells, PhD         
Sponsors and Collaborators
Advanced Accelerator Applications

Responsible Party: Advanced Accelerator Applications
ClinicalTrials.gov Identifier: NCT02667457     History of Changes
Other Study ID Numbers: AAA-Annexin-04
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases