Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06556979
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
Carotid Artery Stenosis and Ischemic Cerebrovascular Events After Radiotherapy in Patients With Head and Neck Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Carotid Artery Stenosis and Ischemic Cerebrovascular Events After Radiotherapy in Patients With Head and Neck Cancer
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RT-CASinHNC
Brief Summary:
The study had a cross-sectional design and included patients with HNC involving the oral cavity pharynx larynx nasal cavity or salivary glands who recieve RT
the investigators obtained information on their clinical and tumor characteristics and their treatment from the clinical records Data on risk factors for atherosclerosis medications used and radiotherapy were also collected
Images were analyzed to determine the timing of development of CAS identify significant ampgt50 CAS using the North American Symptomatic Carotid Endarterectomy Trial criteria and calculate the total plaque score TPS and wall thickness
The purpose of this study was to determine the incidence of ICVE and of CAS in patients who receive radiotherapy for HNC and the risk factors for CAS
the investigators obtained information on their clinical and tumor characteristics and their treatment from the clinical records Data on risk factors for atherosclerosis medications used and radiotherapy were also collected
Images were analyzed to determine the timing of development of CAS identify significant ampgt50 CAS using the North American Symptomatic Carotid Endarterectomy Trial criteria and calculate the total plaque score TPS and wall thickness
The purpose of this study was to determine the incidence of ICVE and of CAS in patients who receive radiotherapy for HNC and the risk factors for CAS
Detailed Description:
The study had a cross-sectional design and included 907 patients with HNC involving the oral cavity pharynx larynx nasal cavity or salivary glands The study was approved by the Chulabhorn Institutional Ethics Committee for Human Research approval number 0482565 All patients underwent radiotherapy to the head and neck region between February 2011 and June 2022 with or without surgical resection and were investigated by computed tomography CT before and after radiotherapy Patients with lymphoma and those with previous treatment for CAS or radiotherapy for other diseases were excluded We obtained information on patient background factors tumor characteristics and treatment from the medical records Risk factors for atherosclerosis including hypertension dyslipidemia diabetes mellitus coronary artery disease peripheral arterial disease and cigarette smoking were identified Baseline laboratory data including hemoglobin A1C fasting blood sugar lipid profile serum creatinine level and estimated glomerular filtration rate were obtained as was information on treatment including antiplatelet agents statins angiotensin-converting enzyme inhibitors ACEIs calcium channel blockers CCBs and anticoagulants The type and stage of HNC indication for radiotherapy type of radiotherapy total cumulative dose and number of courses were also recorded Unfortunately the laboratory data were incomplete in many cases so could not be subjected to statistical analysis Follow-up was continued until loss to follow-up death or the end of 2023 whichever came first Moreover full written informed consent was obtained from the patient for publication of this article Confidentiality of the data was secured by assigning of a code for each patient record Images were analyzed to determine the timing of development of CAS identify significant gt50 CAS using the North American Symptomatic Carotid Endarterectomy Trial criteria and calculate the total plaque score TPS and wall thickness The carotid vessels were divided into the common carotid artery CCA carotid bulb internal carotid artery ICA and external carotid artery ECA The bulb was defined as the portion of the artery 1 cm caudally to 1 cm cranially from the point where the CCA divided into the ICA and ECA The right and left carotid artery systems were each divided into the following five segments proximal CCA 20 mm proximal to bulb distal CCA lt20 mm proximal to bulb carotid bulb ICA and ECA Each segment was graded as follows 0 normal or no detectable plaque 1 plaque occupying lt30 of vessel diameter 2 plaque occupying 30-49 of vessel diameter 3 plaque occupying 50-69 of vessel diameter 4 plaque occupying 70-99 of vessel diameter and 5 100 occlusion of vessel diameter by plaque The carotid plaque score was obtained for each patient by summing the scores obtained for the five arterial segments in both carotid arteries Wall thickness and degree of CAS were measured in the five segments of the carotid artery at baseline and during follow-up Differences in these values were calculated CT was performed at least twice The initial CT scan was performed within 2 months before initiation of radiotherapy and follow-up CT was performed 1 month after completing radiotherapy In cases with multiple follow-up CT scans the last scan was used to evaluate post-radiation change The 1-year follow-up CT scan was also examined All baseline and follow-up measurements were made by a vascular surgeon who was blinded to the clinical data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None