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Coronary Disease clinical trials

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NCT ID: NCT03227588 Recruiting - Clinical trials for Coronary Artery Disease

Evaluation of the Opsens Fractional Flow Reserve (FFR) Wire as a "Work Horse" Wire

Start date: April 10, 2017
Phase:
Study type: Observational [Patient Registry]

The use of fractional flow reserve (FFR) has improved outcomes in percutaneous coronary interventions (PCI) in patients with symptomatic stable coronary artery disease (CAD) with intermediate angiographic stenoses. It is a clinical tool used routinely in cardiac catheterization laboratories throughout the world including the Little Rock VA Hospital. The technique utilizes a pressure transducer constructed as part of an 0.014" guidewire. An FFR of >0.80 has been linked with myocardial ischemia found with nuclear stress and dobutamine echo stress testing. The FAME trial clearly demonstrated its value in improving long-term outcomes as compared to use of angiography alone. As such, the use of FFR is incorporated into both AHA ACC and European PCI guideline recommendations as part of routine care for intermediate lesions. A "work horse" guide wire is so defined because it can be used in most PCI cases. It combines a low tip load (to avoid intimal dissection, with excellent (ideally, one to one) torque transmission and trackability through tortuous lesions. Recently the FDA has approved an FFR guide wire, OptoWire, (Opsens, Quebec City, Quebec, CAN) which uses light transmission to measure pressure rather than electrical transduction wires. The primary purpose of the present study is to determine how effective this wire is as a work horse wire in patients in whom FFR is required. The OptoWire may also have the advantage of less "drift" occurring during the procedure. Drift refers to the change in pressure due to issues related to the wire and measuring system, rather than a true change in pressure. All current FFR wire systems demonstrate some degree of drift requiring measuring pressure of the wire in the aorta after the procedure is completed to determine if, and to what extent, drift has occurred. Thus, a secondary aim of this study will determine the degree of drift.

NCT ID: NCT03217227 Recruiting - Clinical trials for Coronary Artery Disease

Evaluating Myocardial Ischemia in Chest Pain Using Exercise CMR

EMPIRE
Start date: May 1, 2017
Phase:
Study type: Observational

Ischemic Heart Disease (IHD) is a condition of recurring chest pain or discomfort that occurs when a part of the heart is not receiving sufficient blood flow. It is a major public health concern internationally and in Singapore, the leading cause of death from cardiovascular disease. Cardiovascular magnetic resonance (CMR) has the ability to assess heart structures, scarring or lack of blood supply to the heart muscle with great accuracy and without any radiation involved. A CMR-compatible cycle ergometer can offer a safe and low cost stress equipment to assess heart function and motion abnormalities, and restrictions of the blood supply to the heart tissues due to partial or complete blockages of the blood vessels. This study aims 1. to develop an exercise-CMR stress protocol by testing its feasibility and robustness in assessing changes in cardiac volumes and function due to physical exertion in healthy individuals and 2. to assess the accuracy of the multiparametric stress-CMR as a diagnostic tool for ischemic-causing coronary artery disease (CAD) with coronary fractional flow reserve (FFR) as a reference. 3. to measure the overall economic impact of ischaemic heart disease by estimating the direct and indirect medical costs for each participant. The current sample costs will be extrapolated to estimate the annual costs of treating and managing ischaemic heart disease in the local population. 4. to evaluate the effects of coronary microvascular dysfunction on coronary flow and regulation, physiological response and cardiac sympathetic signaling in patients with chest pain.

NCT ID: NCT03209414 Recruiting - Clinical trials for Acute Coronary Syndrome

Frailty Syndrome in Daily Practice of Interventional Cardiology Ward

FRAPICA
Start date: May 17, 2017
Phase:
Study type: Observational

The impact of frailty on immediate and long term outcomes of invasive treatment of coronary artery disease is not fully characterized. The assessment of frailty may help physicians in the selection of best treatment option and in the timing and modality of the follow-up. The FRAilty syndrome in daily Practice of Interventional CArdiology ward (FRAPICA) study is designed with the aim to validate the use of the Fried frailty scale and instrumental activities of daily living scale (IADL) as prognostic tools in patients admitted to hospital for symptomatic coronary artery disease, either stable, unstable, or acute coronary syndrome (ACS). The FRAPICA study is a single center prospective study enrolling patients aged ≥65 years. The aims are (1) to describe Fried frailty scale and IADL scale distribution before hospital discharge and (2) to investigate the prognostic role of Fried frailty and IADL scores. The outcomes are: (1) results of invasive treatment, (2) its complications (periinterventional MI, contrast-induced nephropathy, blood loss), (3) three-year all-cause mortality, cardiovascular mortality, stroke, myocardial infarction, reintervention, heart failure, hospital readmission for any cause, and a composite of the above mentioned. Ancillary analyses will be focused on different clinical presentations, different tools to assess frailty and risk stratification. The FRAPICA program will fill critical gaps in the understanding of the relation between frailty, cardiovascular disease, interventional procedures and outcome. It will enable more personalized risk assessment and identification of new targets for interventions.

NCT ID: NCT03198091 Recruiting - Clinical trials for Coronary Heart Disease

Efficacy of Dun Ye Guan Xin Ning Tablet in Patients With Stable Angina Pectoris

Start date: March 30, 2017
Phase: N/A
Study type: Interventional

This registry is designed to investigate factors affecting the efficacy of Dun Ye Guan Xin Ning tablet on patients with stable angina. The potential hypothesis is that Dun Ye Guan Xin Ning has a better effect on different subgroup patients with certain characteristics.

NCT ID: NCT03175393 Recruiting - Clinical trials for Postprandial Dyslipidemia

Relation Between Postprandial Lipogram and Coronary Artery Disease Severity

Start date: July 1, 2017
Phase: N/A
Study type: Observational

Coronary artery disease (CAD) is usually used to refer to the pathological problem affecting the coronary arteries (usually atherosclerosis) that leads to Coronary Heart disease (CHD) which includes the diagnoses of angina pectoris, MI and silent myocardial ischemia. Despite the mortality for this condition has gradually declined over the last decades in western countries, it still causes about one-third of all deaths in people older than 35 years. Dyslipidemia is very important risk factors of atherosclerosis that is one of the causes leading to cardiovascular disease Despite management of dyslipidemia by controling fasting total plasma cholesterol and LDL cholesterol as these are the best biomarkers for prediction of cardiovascular diseases (CVD) risk. LDL elevation is absent in many patients with atherosclerosis and about 1/3 of cardiac events remains to be unpredicted using this method. Even more, in fasting normolipidemic subjects, increased CVD risk is associated with an exaggerated postprandial lipemic response. Postprandial dyslipidemia is defined as a rise in triglyceride-rich lipoproteins (TRLs), including chylomicron remnants (CMRs) and remnant lipoproteins (RLPs), after eating, has drawn an increasing interest recently because of its association with cardiovascular events. Chylomicron remnants (CMRs) have been shown to penetrate the artery wall and to be retained within the intima. Endothelial dysfunction is an initial process of atherogenesis and it contributes to the pathogenesis of CHD. Postprandial hyperlipidemia (postprandial hypertriglyceridemia) is involved in the production of proinflammatory cytokines, recruitment of neutrophils, and generation of oxidative stress, resulting in endothelial dysfunction

NCT ID: NCT03151018 Recruiting - Clinical trials for Coronary Artery Disease

Effect and Efficacy of Onyx™, Zotarolimus-eluting Stent for Coronary Atherosclerosis

HOST-ONYX
Start date: May 2015
Phase: N/A
Study type: Observational [Patient Registry]

The objectives of this study are 1. To establish a prospective registry of the whole patients who received percutaneous coronary intervention with Resolute Onyx™ stent. 2. To evaluate the long-term efficacy and safety of coronary stenting with the Resolute Onyx™ stent. 3. To compare the long-term efficacy and safety of coronary stenting between the Resolute Onyx™ stent and other contemporary drug-eluting stents which had established their own registry.

NCT ID: NCT03150680 Recruiting - Clinical trials for Coronary Artery Disease

Development of a Risk Prediction Algorithm Through the Investigation of Genetic Risk Factors and the Complexity of Coronary Artery Disease to Estimate Future Risk of Cardiovascular Events: Angiographic (SYNTAX Score), Clinical and Pharmacogenetic Analysis.

GESS
Start date: September 1, 2017
Phase: N/A
Study type: Observational [Patient Registry]

The purpose of the research project is to investigate the potential association of 207 genetic polymorphisms with the complexity and the severity of coronary artery disease (SYNTAX score), along with the patients' response to clopidogrel and statin therapy. The aim of the study is to combine genetic, pharmacogenetic, clinical and laboratory data in order to create an algorithm (GEnetic Syntax Score-GESS) that will enable an individualized therapeutic patient approach.

NCT ID: NCT03117218 Recruiting - Clinical trials for Coronary Artery Disease

Correlation Between Quantitative Analysis of Coronary MRA and FFR

Start date: July 1, 2014
Phase: N/A
Study type: Observational

This study aims to evaluate whether quantitative analysis of coronary MR angiogram would improve the detection of functionally-significant coronary artery stenosis.

NCT ID: NCT03112707 Recruiting - Clinical trials for Coronary Artery Disease

Bioresorbable Polymer-Coated EES in Patients at High Bleeding Risk Undergoing PCI Followed by 1-Month DAPT

POEM
Start date: April 14, 2017
Phase: Phase 4
Study type: Interventional

Objective: To evaluate the safety of bioresorbable polymer-coated everolimus-eluting Synergy® stent followed by 1-month dual antiplatelet therapy in patients at high-bleeding risk. Study population: Real world high-bleeding risk (HBR) patients with coronary artery disease (stable as well as acute coronary syndromes) who qualify for percutaneous coronary interventions. Study size: A total of 1023 patients will be enrolled. Study design: Prospective, single-arm, multicentre trial, powered for non-inferiority with respect to objective performance criteria (OPC). Antiplatelet therapy: Dual antiplatelet therapy with aspirin 100 mg od and a P2Y12 inhibitor for a duration of 1 month, after which single antiplatelet therapy with aspirin will be recommended indefinitely. In case of need for oral anticoagulation, patients will receive an oral anticoagulant in addition to a P2Y12 inhibitor without aspirin for 30 days. Primary endpoint: Composite of cardiac death, myocardial infarction, or definite/probable stent thrombosis at 1-year follow-up.

NCT ID: NCT03106961 Recruiting - Clinical trials for Coronary Artery Disease

OCT and Scaffold Embedding After NC Balloon

Start date: March 30, 2017
Phase: N/A
Study type: Observational

This study is a single-center, prospective, observational study designed to subjects presenting with stable angina pectoris or acute coronary syndromes requiring treatment of de novo lesions. Eligible subjects will have BVS scaffold implant using a high pressure post-scaffold implantation ballooning, designed to specifically address the issue of incomplete BVS expansion. OCT ( optical coherence tomography ) will be used to evaluate the change in the intraluminal scaffold volume and the prevalence of scaffold embedding from post-scaffold implantation to post-dilation high pressure (16-20 atm), non-compliant ballooning in relation to the underlying plaque.