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Coronary Artery Disease clinical trials

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NCT ID: NCT03531424 Recruiting - Clinical trials for Coronary Artery Disease

Augmented-Reality CTA Plus Angiography vs Angiography Alone for Guiding PCI in Coronary Lesions - Randomized Study

Start date: April 25, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to compare revascularization strategy and its immediate results after augmented-reality computed tomography angiography (CTA) guided vs. standard angiography guided percutaneous coronary intervention (PCI) in native coronary lesions.

NCT ID: NCT03531151 Recruiting - Heart Failure Clinical Trials

MRI of Myocardial Infarction

Start date: April 1, 2018
Study type: Observational [Patient Registry]

Heart failure (HF) is an enormous health burden affecting approximately 5.1 million people in the US and is the cause of 250,000 deaths each year. Approximately 50% of HF is caused by myocardial ischemia and requires immediate restoration of coronary blood flow to the affected myocardium. However, the success of reperfusion is partly limited by intramyocardial hemorrhage, which is the deposition of intravascular material into the myocardium. Hemorrhagic reperfusion injury has high prevalence and patients have a much greater risk of adverse left ventricular remodeling, risk of fatal arrhythmia, impaired systolic function and are hospitalized at a greater rate. Recent magnetic resonance imaging techniques have improved assessment of reperfusion injury, however, the association between MRI contrasts and reperfusion injury is highly unclear, and lacks specificity to IMH. Improved imaging of IMH and accurate knowledge about its spatial and temporal evolution may be essential for delivery of optimal medical therapy in patients and critical to identify patients most at risk for adverse ventricular remodeling. The overall goal is to investigate the magnetic properties of hemorrhage and develop MRI techniques with improved specificity to hemorrhage. New MRI techniques permit noninvasive assessment of the magnetic susceptibility of tissues and can target tissue iron. Therefore, we hypothesize that MRI imaging of myocardial magnetic susceptibility can map hemorrhagic myocardium. We will perform a longitudinal observational study in patients after reperfusion injury to validate these methods, compare them with conventional MR contrasts and develop MR methods for imaging live animals.

NCT ID: NCT03529916 Recruiting - Clinical trials for Coronary Heart Disease

Endothelial Cell Gene Networks of CVD

Start date: May 21, 2018
Study type: Observational

The objective of this study is to identify relevant signature gene networks of cardiovascular disease in endothelial cells derived from circulating endothelial progenitor cells of individuals with established cardiovascular disease (CVD).

NCT ID: NCT03529253 Recruiting - Clinical trials for Coronary Artery Disease

Effect of Alirocumab(Proprotein Convertase Subtilisin/Kexin type9 Inhibitor) and Rosuvastatin or Rosuvastatin Alone on Lipid Core Plaques in Coronary Artery Disease Evaluated by Near-infrared Spectroscopy Intravascular Ultrasound

Start date: April 1, 2018
Phase: Phase 4
Study type: Interventional

The purpose of this study is to verify whether additional administration of Alirocumab exerts a stronger stabilizing effect on the vulnerable plaque in CAD, compared with statin alone administration in patients receiving PCI. Therefore, the change in maxLCBI (4 mm) of the coronary artery 9 months after administration by addition administration of Alirocumab is evaluated as the main evaluation item as compared with statin administration alone for patients who have CAD and received PCI. Also, change of plaque properties is compared with baseline and evaluated. This study is a single-center, randomized, open-label study, using alirocumab, rosuvastatin as test drugs. Based on the findings obtained in this study, it is possible to clarify the mechanism of stabilization of the plaque in a patient with coronary artery disease, which in turn suppresses the progress of plaque in coronary artery disease, resulting in primary or secondary There is a possibility that it can contribute to prevention.

NCT ID: NCT03525041 Recruiting - Clinical trials for Coronary Artery Disease

Mitral Valve Repair Combined Coronary Artery Bypass Grafting(CABG) Verus CABG Alone on Functional Ischemic Mitral Regurgitation

Start date: May 1, 2017
Phase: N/A
Study type: Interventional

Coronary artery bypass grafting(CABG) is an effective procedure in treating severe coronary artery disease(CAD). Optimal surgical method for CAD patients with functional ischemic mitral regurgitation(FIMR) is still controversial. This study will evaluate the different effectiveness of CABG plus mitral valve annuloplasty versus CABG alone on patients with moderate FIMR.

NCT ID: NCT03520140 Recruiting - Clinical trials for Coronary Artery Disease

Prevalence of Familial Hypercholesterolaemia (FH) in Italian Patients With Coronary Artery Disease

Start date: June 15, 2016
Study type: Observational

Evaluate the prevalence of familial hypercholesterolemia (FH) in patients with documented coronary artery disease (CAD) event [acute myocardial infarction (AMI), acute coronary syndrome (ACS), coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI)] followed by 100 cardiological centers representative of the whole Italian territory

NCT ID: NCT03518437 Recruiting - Clinical trials for Coronary Artery Disease

Coronary Atherosclerosis Disease Early Identification and Risk Stratification by Noninvasive Imaging

Start date: September 2016
Study type: Observational [Patient Registry]

The investigator prospectively enroll 30,000 outpatients who were suspected of coronary artery disease (CAD) and underwent cardiac computed tomography angiography (CTA). The endpoint was major adverse cardiac events (MACE).The investigator aim to evaluate the prognostic value of CTA, risk factors and bio-markers for MACE.

NCT ID: NCT03511885 Recruiting - Clinical trials for Cardiovascular Diseases

EUROASPIRE V Survey on Cardiovascular Disease Prevention and Diabetes

Start date: May 1, 2016
Study type: Observational

EUROASPIRE is a multicentre European study in coronary patients and individuals at high risk of developing cardiovascular disease (CVD), describing their management through lifestyle and use of drug therapies and providing an objective assessment of clinical implementation of current scientific knowledge. Four EUROASPIRE surveys have been carried out by the European Society of Cardiology so far: EUROASPIRE I in 1995-1997 in nine countries, EUROASPIRE II in 1999- 2000 in 15 countries, EUROASPIRE III in 2006-2009 in 22 countries and EUROASPIRE IV in 2012-2015 in 26 countries. The results showed a wide gap between the recommendations and clinical practice with many patients not achieving the lifestyle and medical risk factors goals for CVD prevention. The fifth EUROASPIRE survey is planned for 2016-2018 to determine in hospital coronary patients and apparently healthy individuals in primary care at high risk of developing cardiovascular disease whether the European and national guidelines on cardiovascular disease prevention have been followed and if the practice of preventive cardiology in EUROASPIRE IV has improved by comparison with those centres which took part in EUROASPIRE I, II, III and IV. This survey will also incorporate an assessment of dysglycaemia and kidney function in all patients. The main outcome measures will be the proportions of coronary and high cardiovascular risk patients achieving the lifestyle, risk factor and therapeutic targets for cardiovascular disease prevention. The data collection will be based on a review of patient medical records and a patient interview and examination at least 6 months and at most 3 years after recruiting event. All countries which participated in the first three surveys will be invited to take part in EUROASPIRE V. This fifth survey will give a unique picture of preventive action by cardiologists and primary care physicians looking after patients with coronary disease and individuals at high CVD risk.

NCT ID: NCT03509532 Recruiting - Clinical trials for Coronary Artery Disease


Start date: January 2017
Study type: Observational [Patient Registry]

Study 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.

NCT ID: NCT03508609 Recruiting - Clinical trials for Coronary Microvascular Dysfunction

Safety and Potential Bioactivity of CLBS14 in Patients With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease

Start date: April 2018
Phase: Phase 2
Study type: Interventional

This clinical trial will explore the safety and effect of GCSF-mobilized autologous ex vivo selected CD34 cells for the treatment of CMD in adults currently experiencing angina and with no obstructive coronary artery disease. Eligible subjects will receive a single intracoronary infusion of CLBS14.