Carotid stenosis: what is the high-risk population?

Park, Jong‐Hun; Razuk, Alvaro; Saad, Paulo Fernandes; Telles, Gustavo José Politzer; Karakhanian, Walter Khegan; Fioranelli, Alexandre; Rodrigues, Alessandra Caivano; Volpiani, Giuliano Giova; Campos, P. D. M.; Yamada, Roberto Massayoshi; Castelli, Valter; Caffaro, Roberto Augusto

doi:10.6061/clinics/2012(08)02

Cited by 16 publications

(9 citation statements)

References 26 publications

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“…Device indication was compared to 2010 Census demographic breakdown as well as disease of indication prevalence by demographic breakdown based on recent studies. 7,8 A p value < 0.05 was utilized throughout the study to define statistical significance. All analyses were conducted using R (version 3.5.2, R Foundation).…”

Section: Discussionmentioning

confidence: 99%

Effect of the FDA Safety and Innovation Act on racial and gender diversity in neurosurgical device trials

Siddiqui

Chiu

Nunna

et al. 2022

Journal of Neurosurgery

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OBJECTIVE The US FDA uses evidence from clinical trials in its determination of safety and utility. However, these trials have often suffered from limited external validity and generalizability due to unrepresentative study populations with respect to clinical patient demographics. Section 907 of the FDA Safety and Innovation Act (FDASIA) of 2012 attempted to address this issue by mandating the reporting of certain study demographics in new device applications. However, no study has been performed on its effectiveness in the participant diversity of neurosurgical device trials. METHODS The FDA premarket approval (PMA) online database was queried for all original neurosurgical device submissions from January 1, 2006, to December 31, 2019. Endpoints of the study included racial and gender demographics of reported effectiveness trials, which were summated for each submission. Chi-square tests were performed on both endpoints for before and after years of FDASIA passage and implementation. RESULTS A total of 33 device approvals were analyzed, with 14 occurring before SIA implementation and 19 after. Most trials (96.97%) reported gender to the FDA, while 66.67% reported race and 63.64% reported ethnicity. Gender breakdown did not change significantly post-SIA (53.30% female, p = 0.884). Racial breakdown was significantly different from the 2010 US Census for all races (p < 0.001) both pre- and post-SIA. Only Native American race was significantly different in terms of representation post-SIA, increasing from 0% to 0.63% (p = 0.0187). There was no significant change in ethnicity. CONCLUSIONS The FDASIA, as currently written, does not appear to have had a significant impact on the racial or gender diversity of neurosurgical device clinical trial populations. This may be due to the noncompulsory nature of its guidance, or a lack of more stringent regulation on the composition of clinical trials themselves.

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Section: Discussionmentioning

confidence: 99%

Effect of the FDA Safety and Innovation Act on racial and gender diversity in neurosurgical device trials

Siddiqui

Chiu

Nunna

et al. 2022

Journal of Neurosurgery

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“…To minimize the risk of CVE following CABG in patients that will undergo elective CABG, we screen patients using carotid artery Doppler at our clinic. Carotid artery stenosis is also seen in young people [10][11][12]. We detected a critical degree of carotid stenosis in six (12%) of 49 patients in the group of young patients aged 40-50 years, proving that this routine is reasonable.…”

Section: Discussionmentioning

confidence: 52%

Carotid artery stenosis in asymptomatic patients undergoing coronary artery bypass grafting: who and when should be screened?

Özyalçın¹,

Diken²,

Yalçınkaya³

et al. 2021

Kardiol Pol

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“…In a study, Millikan and Siekert have found that worsening of neurological symptoms after a stroke is a matter of clinical interest among doctors. 5 Various attempts to find predictors of neurological decline is not universally vetted by clinicians. There are two major stroke types: Ischemia and hemorrhage.…”

Section: Introductionmentioning

confidence: 99%

A case control study: to evaluate the lipid profile in ischemic and hemorrhagic stroke

Sharma¹,

Badyal

2021

Int J Sci Rep

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Background: Stroke, be it ischemia or hemorrhage, is the most common clinical manifestation of cerebrovascular disease of which more than 99% are due to arterial involvement and less than 1% due to venous involvement. The aim of the present study was to assess the lipid profile of patients with ischemic and hemorrhagic stroke and to compare it with control group.Methods: This study was conducted in the Department of Medicine in collaboration with Department of Biochemistry between February 2018 to August 2018 on 50 patients of infarct and 50 patients of hemorrhagic stroke admitted in GMC Jammu and 50 healthy controls. Serum was analyzed for estimation of serum lipid profile including total cholesterol, triglyceride, high density lipoprotein-cholesterol (HDL-C), low density lipoprotein-cholesterol (LDL-C), by using fully automatic analyzer. Results: More than 54% of patients and controls belonged aged more than 60 years, with a total of 81 males and 69 females. Mean values of total cholesterol (233.53±27.09 mg) and LDL (165.89±30.54 mg) showed up higher in hemorrhagic stroke patients however higher mean values of triglycerides (177.80±40.44 mg) showed up in ischemic stroke patients. Serum cholesterol was abnormal among 50% ischemic and 54% hemorrhagic patients. A significant association is found between raised cholesterol, LDL, abnormal HDL and ischemic stroke.Conclusions: A significant rise in total cholesterol level was found in case of both the groups, therefore high risk patients with stroke should be regularly screened for serum lipid profile.

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Carotid stenosis: what is the high-risk population?

Cited by 16 publications

References 26 publications

Effect of the FDA Safety and Innovation Act on racial and gender diversity in neurosurgical device trials

Effect of the FDA Safety and Innovation Act on racial and gender diversity in neurosurgical device trials

Carotid artery stenosis in asymptomatic patients undergoing coronary artery bypass grafting: who and when should be screened?

A case control study: to evaluate the lipid profile in ischemic and hemorrhagic stroke

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