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Myocardial Ischemia clinical trials

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NCT ID: NCT02273648 Active, not recruiting - Clinical trials for Coronary Artery Diseases

BIOTRONIK - BIOFLOW-III Registry French Satellite

Start date: November 19, 2014
Phase: N/A
Study type: Observational

For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedure success. However, the medium to long-term complications range from rather immediate elastic coil or vessel contraction to longer processes like smooth muscle cell proliferation and excessive production of extra cellular matrix, thrombus formation and atherosclerotic changes like restenosis or angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30 to 50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents (BMS), designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis rates in De Novo lesions compared to PTCA alone and decreased the need for CABG. BMS substantially reduced the incidence of abrupt artery closure, but restenosis still occurred in about 20 to 40% of cases, necessitating repeat procedures. The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by adding an antiproliferative drug (directly immobilized on the stent surface or released from a polymer matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly reduced the incidence of restenosis and resulted in better safety profile as compared to BMS with systemic drug administration. These advantages and a lower cost compared to surgical interventions has made DES an attractive option to treat coronary artery disease. Therefore this observational registry has been designed for the clinical evaluation of the ORSIRO LESS requiring coronary revascularization with DES. It is designed to investigate and collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent System in an all-comers patient population in daily clinical practice.

NCT ID: NCT02255864 Active, not recruiting - Clinical trials for Coronary Artery Disease

Safety and Efficacy Study of the Amaranth Medical FORTITUDE Bioresorbable Drug-Eluting Coronary Stent

RENASCENT
Start date: February 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and performance of a new coronary artery stent for treating blockages in the arteries supplying blood to the heart muscle. The Amaranth FORTITUDE scaffold releases a drug (sirolimus) to reduce the likelihood of the treated blood vessel developing a new blockage. In addition, the scaffold dissolves away over time, leaving no permanent implant after the blood vessel has healed.

NCT ID: NCT02248311 Active, not recruiting - Clinical trials for Coronary Artery Disease

"Preventing Cardiovascular Ischemic Events and Arresting Their Consequences in Type 2 Diabetic Population

PRECISED
Start date: September 2014
Phase: N/A
Study type: Observational

Current methods based on traditional Cardiovascular risk factors are not clinically useful for identifying Type 2 Diabetes patients at risk of developing acute Cardiovascular ischemic events (ie.myocardial infarction or stroke). In addition, Cardiovascular ischemic events in Type 2 Diabetes population have worse prognosis than in general population. In fact, there is sufficient experimental evidence indicating that diabetes exaggerates the deleterious effects of ischemic events and worsens their outcome. A prolonged sub-clinical phase exists before a Cardiovascular event occurs in Type 2 Diabetes patients. Therefore, new strategies aimed at identifying those patients with this subclinical Cardiovascular Diabetes and, consequently, more prone to develop Cardiovascular events is a challenge to be met.

NCT ID: NCT02244853 Active, not recruiting - Stroke Clinical Trials

Heart Rate and Cardiovascular Diseases Prognosis in People With Stable Coronary Artery Disease

Start date: September 2013
Phase: N/A
Study type: Observational

The Cardiovascular disease research using Linked Bespoke studies and Electronic Records (CALIBER) e-health database was the data resource for this study. CALIBER links patient records from four different data sources: Clinical Practice Research Database (CPRD), MINAP (Myocardial Ischaemia National Audit Project registry) Hospital Episodes Statistics (HES), the Office for National Statistics (ONS).

NCT ID: NCT02226900 Active, not recruiting - Clinical trials for Multivessel Coronary Artery Disease

Myocardial Hybrid Revascularization Versus Coronary artERy Bypass GraftING for Complex Triple-vessel Disease

MERGING
Start date: August 2014
Phase: N/A
Study type: Interventional

This is a pilot randomized study that aim to assess the safety and feasibility of a hybrid myocardial revascularization strategy (coronary artery by-pass graft and percutaneous intervention) in comparison with conventional surgical coronary bypass grafting.

NCT ID: NCT02208765 Active, not recruiting - Clinical trials for Coronary Artery Disease

Prognostic Value of SPECT-imaging Myocardial Perfusion Heterogeneity

EVAPERF
Start date: January 2015
Phase: N/A
Study type: Interventional

Endothelial dysfunction has been demonstrated to be an early marker of coronary artery disease (CAD). On the other hand, myocardial perfusion single photon emission computed tomography (MP-SPECT) is a widely used technique for evaluation of patients with suspected or known CAD. Preliminary data suggest that myocardial perfusion heterogeneity (a potential surrogate marker of endothelial dysfunction) can be assessed on conventional MP-SPECT, but its additive and independent prognostic value over the presence of myocardial ischemia remain unknown. More over, factual data demonstrate that inhalation of particulate matters and gaz (NO2, CO) from air pollution contributes to the development of cardiovascular diseases in the short and long term. The role of air pollution in endothelial dysfunction has been suggested. Accordingly, the purpose of this study is to evaluate the prognostic value of myocardial perfusion heterogeneity assessed by a new automatized image processing method applied to routine MP-SPECT. The second purpose is to evaluate the role of air pollution exposure in pathogenesis of cardiovascular disease. The main hypothesis is that the presence of myocardial perfusion heterogeneity is predictive of 2-year cardiovascular events in patients referred to the Nuclear Cardiology Department for routine evaluation of known or suspected CAD. The second hypothesis is that microcirculatory coronary dysfunction is a causal link between air pollution and cardiovascular disease.

NCT ID: NCT02202265 Active, not recruiting - Clinical trials for Coronary Artery Disease

Polymorphisms in CD36 and STAT3 Genes and Different Dietary Interventions Among Patients With Coronary Artery Disease

GENUTRI
Start date: August 2014
Phase: N/A
Study type: Interventional

Background: Cardiovascular diseases are the major health problem worldwide and the understanding of genetic contributions on the development of cardiovascular diseases is increasing significantly. The CD36 is a protein associated with uptake of oxidized forms of LDL and the single nucleotide polymorphism (SNP) rs1761667 A/G in the CD36 gene is correlated with increased consumption of total fat. The transcription factor STAT3 is released during the inflammatory acute phase response and the SNP rs8069645 G/A in the STAT3 gene is associated with abdominal obesity and higher intake of saturated fat. Studies have been shown the benefits of the Mediterranean diet in secondary prevention of cardiovascular disease and these dietary patterns have been often studied with nutrigenetic approach; these studies, however, are often limited to European populations, making it difficult to generalize to different populations. Hypothesis: Different dietary approaches may similarly influence in modifying metabolic, inflammatory and anthropometric profile, especially among patients with coronary arterial disease (CAD). The genetic interaction with environmental factors such as the nutrient intake, and the prescription of a different diet according to individual genotype, could influence the development and/or the treatment of cardiovascular diseases. Objective: To evaluate the effect of three dietary approaches on metabolic, inflammatory and anthropometric profile in patients with CAD and possible interactions with polymorphisms in CD36 and STAT3 genes.

NCT ID: NCT02195414 Active, not recruiting - Clinical trials for Coronary Artery Disease

NeoVas Bioresorbable Coronary Scaffold First-in-Man Study

Start date: July 2014
Phase: Phase 1
Study type: Interventional

The NeoVas First-in-Man study is a prospective, two centers, single arm trial, which will enroll a total of 30 patients. The hypothesis of this study is to evaluate clinical feasibility, safety, and efficacy of NeoVas sirolimus-eluting bioresorbable coronary scaffold in the treatment of patients with de novo coronary lesion.

NCT ID: NCT02193971 Active, not recruiting - Clinical trials for Acute Coronary Syndrome

Harmonizing Optimal Strategy for Treatment of Coronary Artery Diseases Trial - Comparison of REDUCTION of PrasugrEl Dose & POLYmer TECHnology in ACS Patients (HOST REDUCE POLYTECH RCT Trial)

Start date: July 2014
Phase: Phase 4
Study type: Interventional

- Study objectives 1. To compare the safety and long-term efficacy of coronary stenting with biostable polymer drug-eluting stent (Promus PremierTM, Xience Alpine®, Resolute Onyx®) with biodegradable polymer drug-eluting stent (Biomatrix®, Biomatrix Flex®, Nobori®, Ultimaster®, Synergy ® and Orsiro®) in patients with acute coronary syndrome 2. To compare the efficacy and safety of 5 mg prasugrel maintenance therapy compared with 10 mg prasugrel maintenance therapy in patients with acute coronary syndrome undergoing percutaneous coronary intervention - Study design : Prospective, open-label, 2-by-2 multifactorial, randomized, multicenter trial to test the following in CHD patients 1. Non-inferiority of biostable polymer drug-eluting stent (Promus PremierTM, Xience Alpine®, Resolute Onyx®) compared with biodegradable polymer drug-eluting stent (Biomatrix®, Biomatrix Flex®, Nobori®, Ultimaster®, Synergy ® and Orsiro®) in terms of patient-oriented composite outcome 2. Non-inferiority of 5 mg compared to 10 mg dose of prasugrel maintenance in terms of major adverse cardiovascular events

NCT ID: NCT02189499 Active, not recruiting - Clinical trials for Coronary Artery Disease

Feasibility Study of the Amaranth Medical FORTITUDE Bioresorbable Drug-Eluting Coronary Stent

MEND II
Start date: September 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and feasibility of a new coronary artery stent for treating blockages in the arteries supplying blood to the heart muscle. The Amaranth FORTITUDE scaffold releases a drug (sirolimus) to reduce the likelihood of the treated blood vessel developing a new blockage. In addition, the scaffold dissolves away over time, leaving no permanent implant after the blood vessel has healed. This study will will be the first evaluation of this stent in humans.