Estudio primario
No clasificado
This is a Prospective randomized controlled study to evaluate the difference of safety,effectiveness between endovascular debulking combined drug-coated balloon and balloon dilatation combined stent angioplasty in treatment of femoral-popliteal artery lesions.
Estudio primario
No clasificado
Este artículo no tiene resumen
Estudio primario
No clasificado
Estudio primario
No clasificado
Objectives: To evaluate the plasma atherosclerotic biomarkers in patients with type 2 diabetes mellitus (T2DM) and arteriosclerosis obliteran (ASO) when treated with Probucol plus Cilostazol in combination and individually. Methods: In this open-label study, patients aged 40-75 years were randomized to receive conventional therapy alone, or with Cilostazol 100 mg bid, or with Probucol 250 mg bid, or with both in combination. Endpoints included changes in plasma biomarker and safety at 12 weeks. Results: Of the 200 randomized patients, 165 for per-protocol and 160 for the safety (QTc intervals) were set, respectively. Probucol significantly reduced total cholesterol (P <0.001), low-density lipoprotein cholesterol (LDL-C), (P = 0.01), and high-density lipoprotein cholesterol (HDL-C) (P < 0.001) compared with conventional therapy. Cilostazol was effective in increasing HDL-C (P = 0.002) and reducing triglycerides levels (P < 0.01) compared with conventional therapy. A trend towards significance was observed for the difference between conventional therapy alone and Probucol plus Cilostazol group for the change in oxidized low-density lipoprotein (Ox-LDL, P = 0.065). No significant effects on the majority of the remaining biomarkers were found across the treatment groups. Conclusions: We have confirmed that Ox-LDL could be a possible plasma atherosclerotic biomarker among the evaluated biomarkers, which reflected the synergetic effect of Cilostazol plus Probucol in patients with T2DM and ASO shown previously in preclinical studies. ©2012 JGC All rights reserved.
Estudio primario
No clasificado
Serum concentration of apolipoprotein B (Apo B) is causally associated with arteriosclerosis cardiovascular disease (ASCVD) risk. Whether ATP-sensitive potassium channels (KATP) variants predict the risk of increased Apo B concentration (≥ 80 mg/dL) and related ASCVD remain less clear. We recruited 522 subjects with elevated Apo B concentration (≥ 80 mg/dL) and 522 counterpart subjects (< 80 mg/dL) from South China to assess the associations of KATP variants (rs11046182, rs78148713, rs145456027 and rs147265929) with the risks of increased Apo B serum concentration (≥ 80 mg/dL), carotid artery stenosis (CAS) ≥ 50% and new-onset ischemic stroke (IS). Our results showed that only KATP SNP rs11046182 (GG genotype) was associated with increased risk of Apo B ≥ 80 mg/dL (adjusted OR=2.17, P<0.001) and CAS ≥ 50% (adjusted OR=2.63, P=0.011). After median 50.6-months follow-up, subjects carrying GG genotype of rs11046182 were associated with higher risk of new-onset IS (adjusted HR=2.24, P=0.024). Further, the exosome-derived microRNAs (exo-miRs) expression profile was identified by next-generation sequencing. 41 exo-miRs were significantly differentially expressed under cross-talk status between high Apo B level (≥ 80 mg/dL) and KATP rs11046182. Our study demonstrated that KATP variant rs11046182 was associated with higher risks of elevated serum Apo B levels and its related ASCVD, and the possible mechanism was related to specific exo-miRs expression profile of KATP rs11046182.
Estudio primario
No clasificado
Este artículo no tiene resumen
Estudio primario
No clasificado
IntroductionDiabetic lower extremity arteriosclerosis obstruction (DLASO) is a common macrovascular complication in type 2 diabetic mellitus (T2DM), which can cause amputations and a higher risk of cardiovascular events. However, there are few effective treatments for DLASO currently. To evaluate the safety and efficacy of Jiedu Tongluo Tiaogan Formula (JTTF) in type 2 diabetic lower extremity arteriosclerosis obliterans and looking for a mechanism of action, we designed a clinical trial and mechanism exploration based on metabolomics technology.
Methods and AnalysisThis study is designed as a randomized controlled clinical trial. A total of 80 participants will be recruited and randomized to a TCM group (JTTF + essential treatments) and a control group (essential treatments) in a ratio of 1:1. The treatment duration is 12 weeks. Changes in clinical symptom scores, color ultrasound Doppler hemodynamics of lower extremity arteries, and Ankle-Brachial Ratio (ABI) will be the primary outcomes. Changes in TCM symptoms scores, other indicators related to arteriosclerosis, blood glucose, lipids, and body mass will be the secondary outcomes. The primary and secondary outcomes will be evaluated at baseline and week 12. Safety outcomes and adverse events will also be properly assessed. After treatment completion, blood and urine samples from subjects will be tested for metabolomics.
DiscussionThis study aims to verify the efficacy and safety of JTTF in type 2 diabetic lower extremity arteriosclerosis obliterans and obtain the key action pathway. It helps to provide scientific evidence for TCM treatment of diabetic vascular complications.
Ethics and DisseminationThis trial has been approved by the Ethics Committee (GZYLL(KY)-2021-024). Results of this trial will be published in journals and presented at scientific conferences. We share raw data in the ResMan network platform. All the authors declare that they have no conflicts of interest.
Trial registrationChinese Clinical Trials Register, ChiCTR2100051337. Registered on 20 September 2021.
Estudio primario
No clasificado
Estudio primario
No clasificado
Estudio primario
No clasificado
Background: A selective 5-HT2 receptor antagonist, sarpogrelate, has been known to improve clinical symptoms in patients with arteriosclerosis obliterans (ASO). Many physicians have conducted in vitro studies to elucidate the mechanism involved in this effect and established that sarpogrelate inhibits platelet aggregation and proliferation of the vascular smooth muscle cells (VSMC). Methods: A total of 50 patients (30 older men and 20 postmenopausal women), all with a history of intermittent claudication and given a diagnosis of ASO, served as the subjects of this study. Sarpogrelate (200-300 mg/day) was prescribed for about 30 months. They were grouped by Fontaine classification (0-3). The intimal-medial thickness (IMT) of their carotid artery and cardiac function were measured and analyzed by ultrasonography and ultracardiosonography. The results of blood chemical analysis, blood pressure, and heart rate were analyzed at intervals of 3 or 6 months (starting at 0, then on the 3rd, 6th, 9th, 12th, 18th, 24th, and 30th month). Pulse wave velosity (PWV) was measured only for the last two years because no devices were available prior to that. The co-morbidity of these patients included: hypertension, diabetes mellitus, ischemic heart disease, cerebrovascular disease, chronic renal failure, chronic glomerulonephritis, nephrotic syndrome, hyperlipidemia, and congestive heart failure. For these conditions, appropriate medication was prescribed in addition to sarpogrelate. Results: The IMT gradually decreased in most of the patients within the 30-month period (p < 0.0001). Sarpogrelate also improved PWV, ankle brachial pressure index (ABI), and cardiac functions (p < 0.0001) in spite of the complications cited above. The medication also enabled the patients with intermittent claudication to walk further distances and for a longer duration without pain in their lower extremities. This finding indicated that sarpogrelate exerts a direct effect to attenuate and inhibit both the progression and exacerbation of atherosclerosis (including arteriosclerosis). None of the patients experienced side effects from sarpogrelate during the trial. Conclusion: In the present study involving patients with ASO, sarpogrelate markedly improved the conditions of intermittent claudication, with increases in ABI and decreases in IMT and PWV, especially in those with diabetes mellitus.