Carotid Revascularization - ClinicalTrials.gov

Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial

Managing and addressing risk factors is essential in stroke prevention. Most strokes are caused by blood leaking to a portion of the brain that is blocked. This trial is designed to find the right way to stop strokes in people with a high volume of blockage in their carotid artery but no symptoms related to the blockage. Diabetes, elevated cholesterol, tab smoking, professional sports, and diet will all be monitored closely during the trial. Participants will remain in the study for four years.

Source link: https://clinicaltrials.gov/ct2/show/NCT02089217

Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial - Hemodynamics

The MR or CT imaging, which will be done at baseline for all patients in CREST-H and at 1 year for those with hemodynamic impairment at baseline, will be included in this protocol. The protocol will instruct and obtain the study-related MRI sequences, upload de-identified image files to the CREST-2 central imaging site at U Maryland, and keep hemodynamic imaging results blinded. The procedure described in the new Imaging MOP for CREST-H will be used for CT perfusion imaging. The CT perfusion study is similar to the clinical CTP protocol used for acute stroke imaging in most hospitals. In the proxilateral hemisphere's middle cerebral artery and anterior cerebral artery territories of the carotid lesion, TTP > 1. 25 sec is measured as TTP > 1. 25 sec in the proxilateral hemisphere's carotid lesion, relative to the same region in the opposite hemisphere. In each case with MR imaging, the continuous Tmax variable, as well as standard perfusion parameters of CBV, CBF Tmax, and MTT will be investigated on the serial imaging studies. The findings of the perfusion scan will not be blinded to the investigator team in order to ensure that the PWI scan report from CREST-H does not jeopardize the parent trial's credibility. The VIC at U Maryland and UCLA is a unique ftp linkage, and the VIC at U Maryland and UCLA will be used to create every perfusion image file available for download by UCLA and every architectural image by Mayo-Rochester. The VIC at U Maryland and UCLA is a licensed ftp linkage between the VIC at U Maryland and UCLA, as well as the VIC at U Maryland and UCLA; and the VIC at U Maryland and Mayo-Ro The Huston lab's automated T2 WMH volume — White matter hyperintensity volume — refers to confluent periventricular high intensity lesions on FLAIR imaging — and can be calculated using an automated T2 WMH quantification system. Images from image analysis performed at UCLA and Mayo-Rochester will be entered electronically on CREST-H data forms on the CREST-2 SDCC website at UAB, where it will be stored on a separate webpage linked to the rest of the CREST-2 survey's CREST-H database, which will include baseline and annual cognitive assessments. The electronic data entry system for CREST-2 is a mature device that has been successfully tested by FDA audit in other studies, proving universal methods for entry-confirmation-locking of data types and supporting range and validity checking for data provided. Determine whether cognition can be enhanced by revascularization among a subset of CREST-2 patients with hemodynamic abnormality at baseline. The parameter of concern for the primary hypothesis is u03b23, which will determine if the change in cognitive scores between baseline and 1-year is similar for those with flow failures in comparison to those without flow failure. The method used to analyze the number of new silent infarcts will vary according to the average number and distribution of the number of new infarcts.

Source link: https://clinicaltrials.gov/ct2/show/NCT03121209

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