99mTc-rhAnnexin V-128 Imaging for Carotid Atherosclerosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02667457|
Recruitment Status : Recruiting
First Posted : January 29, 2016
Last Update Posted : August 17, 2018
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- 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
- 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.
- Aortic uptake correlation [ Time Frame: Day 0 ]99mTc-rhAnnexin V-128 uptake in carotids will be correlated to aortic uptake in all participants
- 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
- Laboratory tests [ Time Frame: At Baseline and Day 30 ]Pattern of participants with abnormal laboratory values will be analyzed based on clinical relevance
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
|Contact: Terrence Ruddy, MD, FRCPC, FACC||+1 email@example.com|
|University of Ottawa Heart Institute||Recruiting|
|Ottawa, Ontario, Canada, K1Y 4W7|
|Contact: Terrence Ruddy, MD, FRCPC, FACC 613-761-4085 firstname.lastname@example.org|
|Contact: Marlie Poirier, Clinical Trial Coordinator email@example.com|
|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|