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Carotid Artery Stenosis - ClinicalTrials.gov

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Last Updated: 03 August 2022

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An Exploratory, Phase II, Open Label, Single-Center, Non-Randomized Study Of [F-18] RGD-K5 Positron Emission Tomography (PET) In Participants With Carotid Artery Stenosis

The primary objectives of this exploratory research are: increased integrin expression and enhanced angiogenesis in participants undergoing carotid endarterectomy; and subsequently determine if carotid plaque that causes significant stenosis [in participants undergoing carotid endarterectomy] are among the key objectives of this research. If these labs have not been obtained within 30 days before the research imaging procedures, the investigators will perform a tube of blood to check kidney function and other necessary blood samples prior to the clinical testing. Subjects will be contacted by phone the day after their PET scans were done to see if Subjects have any medical issues and what medications have taken since the PET scan. The benefit of the study to the patient is that it will tell the physician treating the patient the full extent of the carotid plaque, plaque composition, and inform them of the anatomy of the carotid artery in question. On the CSMC network, a summary of the process by which confidentiality will be maintained: In a locked cabinet in a safe location, research information will be stored in a shared network folder. Only accredited research staff who are approved by the Institutional Review Board will be given access to identifiable subject details. On abstraction, the study results will be coded for abstraction, so that Direct Identifiers** are maintained separately from the data set. STUDY'S RISKS II STUDY'S RISKS OF THE STUDY As with any scientific study, there could be adverse events or side effects that are currently unknown, and it is likely that some of these unknown risks could be permanent, significant, or life threatening. Radiation Risk: It is unlikely that participants will suffer any adverse effects as a result of the radiation exposure they receive from participating in this study, which is very unlikely. On a magnetic resonance imaging scan, certain organs, abnormalities, or disease processes are more apparent when intrainjected into the body. In patients with severe renal disease, the risk of gadolinium contrast is negligible. Itching of the skin Headache Nausea is one of the most common adverse effects of gadolinium agents Itching of the skin is the most common adverse reaction to the drug Itching of the skin The skin Headache Nausea is a rare occurrence of local pain Hypersensitivity is rare, but it can produce low blood pressure and lightheadedness. Skin thickening, joint pain, and/or swelling may occur, giving the sensations of burning, itching, and pain that can be severe. Participants will perform kidney function by blood testing, and if the blood test results is abnormal, they will not be able to obtain gadolinium. People with late stage renal disease or people who have had a liver transplant are not healthy for Gadolinium.

Source link: https://clinicaltrials.gov/ct2/show/NCT03364270


Ultrasonographic Morphology Assessment of Low-grade Carotid Stenosis

Atherosclerosis is prone to the carotid bulb found upstream of internal carotid artery origins. Carotid artery thrombosis or atherosclerotic plaque fragmentation, both of which may leak into the brain, triggering carotid stenosis. paraphrased artery origin obstruction rates are determined by the bulb and internal carotid artery origins when carotid stenosis is suspected. The reference method for determining carotid stenosis is based on hemodynamic criteria that only allow the diagnosis of high stenosis thresholds. Two methods of carotid stenosis morphological quantification with Doppler ultrasound currently exist. Calibre reduction at the highest level of stenosis can be determined by comparing the smallest luminal diameter to the vessel diameter at the stenosis site or to the downstream internal carotid artery diameter.

Source link: https://clinicaltrials.gov/ct2/show/NCT05437991

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions