Coronary Artery Disease Progression in Patients With Acute Coronary Syndromes and Diabetes Mellitus...
Coronary Artery DiseaseDiabetes MellitusA total of 100 patients with non-ST-segment elevation acute coronary syndromes with or without diabetes mellitus will be included. All patients will undergo coronary angiography with identification of the infarct-related vessel and percutaneous revascularization with implantation of a stent/scaffold. After revascularization patients will undergo a combined positron emission tomography (PET)-coronary computed tomography (CT) protocol to quantify atherosclerotic burden (i.e. plaque volume) and activity (i.e. 18 fluorum-sodium-fluoride [18FNaF] uptake) in non-infarct related vessels, to assess calcium score (aim 1), and to quantify the acute results of PCI in the infarct-related vessel (aim 2). At 12-month follow-up, all patients will repeat longitudinal 18FNaF PET-coronary CT evaluation to characterize progression of atherosclerosis in the non-infarct related vessels (aim 1) and to quantify neointimal suppression at the site of the treated coronary segment in the infarct-related vessel (aim 2). Blood samples will be collected at baseline and 12 months for all patients. The aims of the study are: To evaluate coronary artery disease progression in acute coronary syndromes patients with and without diabetes mellitus, and to investigate the predictive value of metabolic profiles, patterns of circulating miRNAs and inflammatory mediators on coronary artery disease progression; To evaluate the progression of disease within the infarct-related vessel treated with the use of bioresorbable stent/bioresorbable polymer stents in diabetic and non-diabetic patients with acute coronary syndromes.
DRUG ELUTING STENT FOR DIABETIC PATIENTS IN CORONARY ARTERY DISEASE TREATMENT
Coronary Artery DiseaseStudy Title A post market registry of Abluminus® sirolimus eluting coronary stent system for percutaneous intervention in patients with diabetes mellitus Purpose The purpose of this registry is to prospectively capture clinical data of ABLUMINUS® sirolimus eluting stent in patients with Diabetes Mellitus. Investigational Device ABLUMINUS® sirolimus eluting stent consists of four components; a bare metal stent (BMS), a delivery system, the bio absorbable polymer delivery matrix and Abluminal surface coating on stent and parts of balloon in Pre-crimped condition the anti-proliferative drug, Sirolimus. Study Design Prospective, Observational, Multi-center registry Estimated Enrolment 1000 patients End points Primary Endpoints: Target Lesion Failure that is composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target lesion revascularisation within 12 months. Components of the primary end point are defined as follows: Cardiac Death: any death due to immediate cardiac cause, deaths related to the procedure, unwitnessed death, and death of unknown cause. Target Vessel Myocardial infarction: categorised according to the Minnesota electrocardiographic criteria (Q-wave and non-Q-wave). Spontaneous myocardial infarction was defined as a typical rise and fall of creatinine kinase-MB fraction or troponin in the presence of at least one of several conditions: ischaemic symptoms, new pathological Q waves, ischaemic electrocardiographic changes, or pathological evidence of acute myocardial infarction. Peri-procedural myocardial infarction was defined as an increase in creatinine kinase to more than twice the normal value with increased values of confirmatory biomarkers (creatinine kinase-MB fraction or troponin higher than usual). Target-vessel-related myocardial infarction was one related to the target vessel or that could not be clearly related to another vessel. Target Lesion Revascularisation: any repeat percutaneous or surgical intervention due to a stenosis or occlusion within the device of the index procedure. Secondary Endpoints Stent thrombosis [Time Frame: 1 month, 12 months, yearly]. Definite and probable stent thrombosis according to ARC definitions; Cardiac death [Time Frame: 1 month, 12 months, yearly] Target Vessel Myocardial infarction [Time Frame: 1 month, 12 months, yearly] Target Lesion Revascularisation [Time Frame: 1 month, 12 months, yearly] Device Success at 24 hours Lesion Success at 24 hours Procedural Success at 24 hours Eligibility Eligible Age: 18 Years and older. Eligible Genders: Both. Inclusion Criteria The patient must be at least 18 years of age. Diabetic patient having clinical evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia or positive functional study; acute coronary syndromes will be considered). The patient is an acceptable candidate for percutaneous trans-luminal coronary angioplasty (PTCA) stenting and emergent coronary artery bypass graft (CABG) surgery. Culprit de novo lesion in a native coronary artery with significant stenosis (>50% by visual estimate) eligible for stent implantation (no limitation on the number of treated lesions, vessel and lesion length); Patients included are those for whom the physician has already considered worthwhile the use of Abluminus Stent according to the indications provided by the IFU; Patient provides written informed consent; Patient agrees to all required follow-up procedures and visits. Exclusion Criteria • The patient has a known hypersensitivity or contraindication to any of the following medications:Heparin, Aspirin, Both Clopidogrel and TIclopidine, Sirolimus, paclitaxel, ABT 578Stainless steel, Cobalt, biodegradable PLLA polymer. Patients with hypersensitivity to contrast media who cannot be treated with adequate prophylaxis. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrolment into this study. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions Previous coronary intervention on target vessel. Non-cardiac co-morbid conditions with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment). Lesions not allowing a complete balloon inflation or stent deployment. Clinical Follow up At Discharge, 1 month, 6 months, 12 months, yearly.
MAGnesIum Alloy Scaffold for Coronary Artery Disease (MAGIC)
Coronary Artery DiseaseMyocardial InfarctionThe retrospective study will investigate the clinical performance and long-term safety of scaffold implantation in a real world setting including high volume PCI centers in Italy
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With High Risk Coronary...
DyslipidemiaHigh Risk Coronary Artery DiseaseThe primary objective was to evaluate the effect of treatment with evolocumab on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in patients with high risk coronary artery disease.
The ASSURE ROT Registry: Bioresorbable Vascular Scaffold Following Rotablation for Complex Coronary...
Cardiovascular DiseasesCoronary Artery Disease8 moreThe registry aims to evaluate the safety, performance and efficacy of the Everolimus-eluting bioresorbable vascular scaffold (BVS) system following rotational atherectomy in patients with complex de novo native coronary artery lesions in all-day clinical practice.
BIOFLOW-III All-comers Orsiro Safety and Performance Registry
Coronary Artery DiseaseMyocardial IschemiaThis registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES).
The Alteration of HDL Protein Composition in Patients With Coronary Heart Disease Before and After...
Coronary Heart DiseaseThe protein composition of HDL is complicated. The investigators have identified 40 distinct proteins associated with HDL by proteomics technology, and these proteins have been confirmed to be related to the function of anti-inflammation, anti-oxidation, improvement of endothelial function, inhibition of thrombosis and so on. And the investigators also found that the levels of some proteins in HDL changed in patients with coronary heart disease, compared with the healthy control group. So, this study is to conduct in the two following aspects: enlarge the sample size to verify the preliminary results to find new research ideas of pathogenesis and biomarkers for coronary heart disease; and study the changes of HDL protein composition in patients with coronary heart disease before and after statins treatment using proteomics technology in order to find the mechanism of statins pleiotropic effects and indicators for evaluating the treatment effectiveness.
Safety Study of Kudiezi (a Chinese Medicine Injection) Used in Hospitals in China
Coronary Heart DiseaseAngina PectorisThis study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in October 2011. It was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'. Kudiezi is kind of Chinese Medicine injection used for treating coronary heart disease and angina pectoris in many Chinese hospitals. The purpose of this study is to determine adverse drug events or adverse drug reaction in large sample size 30,000 patients.
Myocardial Ischaemia After Exposure to Diesel Exhaust
Coronary Heart DiseaseExposure to particulate air pollution is associated with increases in cardiovascular mortality and morbidity. The pathophysiological mechanisms underlying this observation are emerging, and exposure to particulate air pollution has been shown to result in increases in blood pressure and arterial tone, impaired vascular function and an increased tendency for blood to clot as well as an increase in atherosclerotic plaque burden. Recent evidence from panel studies and controlled exposure studies have suggested an increase in myocardial ischaemia (a reduction in blood flow to the heart) following exposure. In this study we aim to investigate directly myocardial (heart) blood flow following exposure to diesel exhaust (as a model of urban air pollution) using CT/PET myocardial perfusion imaging in male patients with stable coronary disease and healthy male controls. We hypothesize that following exposure to dilute diesel exhaust: Myocardial blood flow will be reduced Coronary flow reserve will be impaired The magnitude of impairment will be higher in patients with coronary disease as compared to healthy controls
Relationship Between Dosage of Clopidogrel and Platelet Aggregation in Chinese With Different Genotype...
Coronary Heart DiseaseThis study is a prospective, observational study to estimate the relationship between dosage of clopidogrel and platelet aggregation in Chinese with different genotype. The investigators suppose both pretreatment dosage of clopidogrel before percutaneous coronary intervention (PCI) and CYP2C19 genotype may effect the platelet aggregation as well as clinical outcome.