scholarly journals Update on Carotid Revascularization: Evidence from Large Clinical Trials

10.5772/57153 ◽  
2014 ◽  
Author(s):  
Hussien Heshmat ◽  
Foad Abd-Allah ◽  
Mohammad Wasay
Keyword(s):  
Clinical Trials ◽  
Carotid Revascularization

scholarly journals Carotid revascularization and medical management for asymptomatic carotid stenosis: Protocol of the CREST-2 clinical trials

2017 ◽  
Vol 12 (7) ◽  
pp. 770-778 ◽  
Author(s):  
Virginia J Howard ◽  
James F Meschia ◽  
Brajesh K Lal ◽  
Tanya N Turan ◽  
Gary S Roubin ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Carotid Stenosis ◽  
Medical Management ◽  
Asymptomatic Carotid Stenosis ◽  
Asymptomatic Carotid ◽  
Carotid Revascularization

Abstract TMP34: The Challenge and Yield of Racially and Ethnically Diverse Patient Populations in Low Event-Rate Clinical Trials

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Alice J Sheffet ◽  
Albert Sam ◽  
Zafar Jamil ◽  
Fred Weaver ◽  
David Chiu ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Proportional Hazards ◽  
Event Rate ◽  
Alternative Hypothesis ◽  
Self Report ◽  
Carotid Revascularization ◽  
History Of ◽  
Race Ethnicity ◽  
Outcome Differences ◽  
Study Participants

Background: Concern for underrepresentation of minorities in clinical trials has focused on enrollment proportions and generalizability. The interplay of trial event-rates with diversity has not been emphasized. Methods: The Carotid Revascularization Endarterectomy vs Stent Trial (CREST) randomized 2502 patients and compared them by race, ethnicity, baseline characteristics, and primary outcome (any peri-procedural stroke, death or MI and subsequent ipsilateral stroke up to 10 years); those with unknown race or ethnicity were excluded. Proportional hazards models adjusting for age, sex, symptomatic status and treatment were used to test for a treatment by race/ethnicity interaction. Results: One-hundred-nine patients (4.4%) were black, 32 (1.3%) Asian, 2332 (93.4%) white, 11 (0.4%) other by self-report, and 18 (0.7%) unknown; 90 (3.6%) were Hispanic, 2377 (95%) non-Hispanic, and 35 (1.4%) unknown. Compared to whites, racial minorities were younger (mean age 67±8.9 vs 69±8.8, p=0.004), more often female (44% vs 34%, p=0.01), symptomatic (63 vs 52%, p=0.01), and diabetic (51% vs 29%, p<0.0001), but less often dyslipidemic (76% vs 85%, p=0.004), current smokers (19% vs 27%, p=0.04), or had a history of cardiovascular disease (34% vs 46%, p=0.007). Hispanics were more often diabetic (48% vs 30%, p=0.0002). The rate of the primary endpoint was 10.9%±0.9% at 10 years, and did not differ by race or ethnicity (p inter >0.24). In the context of this low rate, even if minority recruitment were increased to represent 50% of study participants, and if the treatment difference in one race were a greater hazard of HR = 1.49 (anticipated alternative hypothesis), then the hazard ratio in the other group would need to be <0.73, or >3.31, to have 90% power of detection. Conclusions: The proportion of racial and ethnicity participation in CREST was suboptimal at < 10%. Primary outcomes did not differ by minority or ethnic status. However, in low event-rate trials very high and even unrealistic enrollment goals for diversity, for example ≥50%, may still be insufficient for detection of outcome differences by race or ethnicity.

scholarly journals Carotid stenting with proximal cerebral protection in symptomatic low-grade vulnerable recurrent carotid stenosis

2018 ◽  
Vol 9 (6) ◽  
pp. 125-133 ◽  
Author(s):  
Joaquin de Haro ◽  
Javier Rodriguez-Padilla ◽  
Silvia Bleda ◽  
Cristina Cañibano ◽  
Ignacio Michel ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Carotid Stenosis ◽  
Randomized Clinical Trials ◽  
Survival Rates ◽  
Carotid Stenting ◽  
Cerebral Protection ◽  
Low Grade ◽  
Carotid Revascularization ◽  
Technical Success Rate ◽  
Plaque Ulceration

Background: Although the management of carotid disease is well established for symptomatic lesions ⩾70%, carotid revascularization for symptomatic low-grade (⩽50%) stenosis is not actually supported by data from randomized clinical trials. Such patients may occasionally have recurrent neurological symptoms despite optimal medical treatment owing to vulnerable plaques. In such cases, carotid artery stenting (CAS) may represent an option for treatment but this has not been tested in clinical trials. This study analyzed early and long-term outcomes of CAS performed in patients with low-grade symptomatic recurrent carotid stenosis. Methods: From a prospective registry of 322 carotid revascularization in symptomatic patients, 21 consecutive patients with low-grade symptomatic recurrent carotid stenosis who underwent CAS with proximal cerebral protection device Mo.Ma, after ruling out any other source of cerebral embolization, were involved in the study. All patients had suggestive evidence of unstable plaque or plaque ulceration. Results: Procedural technical success rate was 100%. No 30-day stroke or death occurred, and no patients had recurrent neurological events related to the revascularized hemisphere during follow up. No 30-day local complications were reported. No late carotid occlusions were detected. There was one late death, and no stroke-related deaths. Survival rates were 100% at 1 year and 96% at 3 years. Conclusions: This study shows that CAS is a well-tolerated, effective and durable treatment for patients with recurrent symptomatic low-grade carotid stenosis associated with a vulnerable plaque. Patients had excellent protection against further ischemic events and survived long enough.

Localization of Gallium-67 in Peritoneal Cells by Electron Microscopic Autoradiography

1973 ◽  
Vol 31 ◽  
pp. 404-405
Author(s):  
D. C. Swartzendruber ◽  
Norma L. Idoyaga-Vargas
Keyword(s):  
Clinical Trials ◽  
Soft Tissue ◽  
Tumor Tissue ◽  
Soft Tissue Tumors ◽  
Clinical Usefulness ◽  
Electron Microscopic ◽  
Normal Cells ◽  
Electron Microscopic Autoradiography ◽  
Peritoneal Cells ◽  
Gallium 67

The radionuclide gallium-67 (67Ga) localizes preferentially but not specifically in many human and experimental soft-tissue tumors. Because of this localization, 67Ga is used in clinical trials to detect humar. cancers by external scintiscanning methods. However, the fact that 67Ga does not localize specifically in tumors requires for its eventual clinical usefulness a fuller understanding of the mechanisms that control its deposition in both malignant and normal cells. We have previously reported that 67Ga localizes in lysosomal-like bodies, notably, although not exclusively, in macrophages of the spocytaneous AKR thymoma. Further studies on the uptake of 67Ga by macrophages are needed to determine whether there are factors related to malignancy that might alter the localization of 67Ga in these cells and thus provide clues to discovering the mechanism of 67Ga localization in tumor tissue.

Patients' satisfaction in clinical trials

2000 ◽  
Vol 248 (6) ◽  
pp. 441-442 ◽  
Author(s):  
L. Terenius
Keyword(s):  
Clinical Trials ◽  
Patients Satisfaction

Blinding Approaches for Large Clinical Trials Involving Sub-Cutaneous Administration of Biologicals – A CMC Perspective

2020 ◽  
Author(s):  
Brice Gassiat ◽  
Benoit Strobbe ◽  
Roberto Giovannini ◽  
Sachin Dubey
Keyword(s):  
Clinical Trials ◽  
Cutaneous Administration

Rome I versus Rome II; Overlap in patients enrolled in tegaserod phase III clinical trials for irritable bowel syndrome (IBS)

2001 ◽  
Vol 120 (5) ◽  
pp. A284-A284
Author(s):  
B NAULT ◽  
S SUE ◽  
J HEGGLAND ◽  
S GOHARI ◽  
G LIGOZIO ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Irritable Bowel Syndrome ◽  
Phase Iii ◽  
Phase Iii Clinical Trials ◽  
Irritable Bowel ◽  
Rome I

Clinical trials screening: An opportunity to increase medical care access

2001 ◽  
Vol 120 (5) ◽  
pp. A410-A410
Author(s):  
T KOVASC ◽  
R ALTMAN ◽  
R JUTABHA ◽  
G OHNING
Keyword(s):  
Clinical Trials ◽  
Medical Care ◽  
Care Access

The Payoffs and Pitfalls of Participating in Clinical Trials

2008 ◽  
Vol 39 (4) ◽  
pp. 53
Author(s):  
CAROLYN SACHS
Keyword(s):  
Clinical Trials
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