Active clinical trials for "Coronary Artery Disease"

The slowly accruing evidence on the treatment of patients with left main coronary artery (LMCA) disease drove evolution in guidelines, that currently establish equivalent safety and efficacy for percutaneous coronary intervention (PCI) as compared to surgery, with a class of recommendation that is subjected to the extension and complexity of concomitant coronary artery disease, as assessed by the SYNTAX score. The severity of LMCA disease, although extremely relevant due to the extent of the supplied myocardium, is often difficult to assess with traditional angiography, due to lack of appropriate angiographic views, absence of a true "reference" segment, interaction with the intubating catheter. Intravascular techniques with either imaging or functional assessment have been variously tested, although with a disturbing rate of discordant results; moreover, they are frequently underused for a number of reasons, including the additional time needed to assess both left anterior descending (LAD) and left circumflex (LCx) arteries, technical challenges, costs and the small risk associated with maneuvering such devices. Fractional flow reserve (FFR) measured from the coronary angiogram (FFRangio) alone recently documented a high diagnostic accuracy compared with pressure-wire derived FFR. As for the anatomical localization, the majority of LMCA lesions occur at the bifurcation, where PCI results are less favourable. The distal LMCA differs from the other bifurcations in several characteristics: a) a notable mismatch between the LMCA and the left anterior descending (LAD) artery, hampering the selection of an adequately sized stent, b) the presence of a trifurcation, with a large ramus arising from LMCA in about 10% of cases, c) the presence of left or co-dominant circulation, with the LMCA supplying all or nearly all left ventricular myocardium in about 15% of cases. Therefore, although the European Bifurcation Club (EBC) recommends a provisional side branch approach in most cases of distal LMCA disease, the threshold for placing a second stent in the side branch may be lower in lesions located on LM bifurcation compared with non-LMCA bifurcations. As for double stenting, the evidence is controversial and a consensus is lacking. Moreover, the optimal treatment of patients with LM trifurcations is still undefined. The aim of this study is therefore to determine the optimal strategy for the treatment of LM bifurcated lesions.

ST segment elevation myocardial infarction (STEMI) is one of the leading causes of death across the world and immediate treatment with either thrombolytics or percutaneous coronary intervention (PCI) results in lower mortality. It is essential to accurately determine the time of onset of myocardial infarction. Standard practice is to take the time of symptom onset as a surrogate for artery occlusion time. However symptom onset is a subjective parameter and affected by multiple factors such as recall issues in elderly patients and preceding unstable angina symptoms before artery occlusion. In a recent study by Mahmoud et al. an objective method, biochemical onset time is proposed for estimation of artery occlusion time using serial cardiac troponin T (cTnT) levels in patients with STEMI. However, this study was retrospective, had an average of two measurements of cTnT for each patient, peak troponin level was frequently missing and newer earlier detectable biomarkers such as high sensitive Troponin I (hsTnI) were not used. We plan to use multiple samples of hsTnI for each patient using the same method as above and we will compare the biochemical ischemic time with the patient reported symptom onset time. Secondarily, we will try to determine whether a single sample of multiple cardiac biomarkers with different release kinetics drawn at time of patient presentation in emergency room (ER) could predict precise time of onset of myocardial infarction. OBJECTIVES To determine the biochemical onset time using multiple hsTnI measurements from each patient (zero, 03, 08, 24 hrs), and compare this biochemical time to the patient-reported symptoms onset time as an indicator of coronary artery occlusion. To predict biochemical occlusion at the time of presentation with the use of single sample of six different markers of myocardial injury. To assess the association of conventional ischemic time and biochemical ischemic time with infarct size; using peak hsTnI, percent ejection fraction by Echocardiography and Cardiac Magnetic Resonance imaging (CMR) based infarct volume in grams. To assess the association of conventional ischemic time and biochemical ischemic time with in-hospital and 30-days major adverse cardiac events, MACE; a composite of heart failure, shock, re MI or death. A prospective nonintervention pilot study will include 100 consecutive patients coming with acute STEMI. Patients' recruitment will be done in ER of Tabba Heart Institute, Karachi Pakistan.

This is a single-center, observational, prospective study. This study aims to observe the effect of periprocedural myocardial injury on cardiovascular events in patients undergoing elective percutaneous coronary intervention, and to detect the levels of serum inflammatory factors before and after intervention to predict the occurrence of periprocedural myocardial injury and its association with cardiovascular events.

This observational study will follow participants who completed follow-up in the FOURIER OUTCOMES trial to evaluate the long-term effects of evolocumab treatment. Long-term post-trial (legacy) beneficial effects have been reported with statins, niacin, hypoglycemic therapy and fibrates. Whether similar effects are seen after LDL cholesterol (LDL-c) lowering by PCSK9 inhibition is currently unknown. Evolocumab therapy causes a profound reduction in LDL cholesterol of approximately 60%. Statins have shown legacy effects over 5 years post-trial, including a 7% reduction in total mortality in meta-analysis and 12% reduction in coronary mortality. It would therefore be hypothesized that additional effects beyond the trial period would be conferred by previous evolocumab treatment. It is also important to assess the long-term safety of prior evolocumab treatment.

A retrospective cohort study was performed in patients with angina pectoris who were treated with oral Chinese patent medicine and Western medicine.The hospital's medical record management system was used to collect symptoms of angina pectoris, dose and frequency of nitroglycerin use, clinical biochemical test and imaging examination.To explore the clinical efficacy of Chinese patent medicine in the treatment of coronary heart disease with angina pectoris, and provide reliable data support for its clinical application.

There are many patients hospitalized for chest pain, which don't have high risk features that require invasive coronary angiography, but are considered intermediate risk and for which ischemic heart disease can not be excluded. The current management for these patients is to perform a non invasive test in order to classify their risk. Exercise ergometry is a commonly used non invasive test to detect ischemia. that test is non-invasive, and does not involve radiation or intra-venous contrast. The test is limited for many patients, because of un-ability to exercise, or because of non-interpetable Electro Cardio-Graphy (ECG). Heart rate variability is well known to be a marker of ischemic heart disease. Heart rate variability testing is a non-invasive ECG monitoring technique. The study design is to identify hospitalized patients who are candidates for non-invasive stress testing, and to monitor their heart rate variability for one hour prior to the stress test.

Coronary drug-eluting stent (DES) has been launched in China for more than ten years. Although it effectively decreases the overall incidence of re-stenosis, DES cannot inhibit the progression of atherosclerosis plaque outside segments. It was shown that the progression rate of non-target atherosclerosis plaque for patients with DES implantation was 6-10%, which indicated that current secondary prevention for coronary heart disease (CHD) is far from the achievement of ideal conditions. Atherosclerosis has many risk factors based on current CHD guidelines, among which the level of low-density lipoprotein (LDL) is the most concerned one. Large clinical studies on statins were performed in the world during the past 20 years. It was demonstrated in these studies that statins were significant to both primary and secondary preventions of CHD. What's more, the lower of LDL level is reached, the lower incidence of clinical cardiovascular events is achieved. However, cardiovascular events were still not avoidable especially for the secondary prevention of CHD even if the level of LDL was significantly controlled under the recommended range of guidelines by high dosage of statins. It was shown in some recent studies that high loading dosage of statins may effectively control the progression of coronary plaque. However, multiple studies found it was hard to control the progression of all patients of coronary plaque due to individual difference. Currently China Food and Drug Administration (CFDA) has not approved the loading dosage of all statins because of possible high safety issues and confusions about the appropriate application in Chinese patients, as well as economy burden to Chinese patients with high treatment cost. How to evaluate individual progression risk of coronary plaque and enhance risk factors control and the treatment of statins for necessary population, is currently an issue, which should be solved in the diagnosis and treatment of CHD. The inhibition in the progression of atherosclerosis plaque is not absolutely dependent on the decrease of LDL. Large number of studies found other risk factors. For instance, diabetes and chronic kidney diseases may also be associated with the progression of plaque. However, the potential impact and control are still uncertain up to date. Based on these background, we design a retrospective study, Risk Factors Promoting Coronary Plaque Progression In China (The RIPPER Study), to solve these issues.

Dual antiplatelet therapy consisting in aspirin and clopidogrel is the cornerstone of the treatment of the prevention of the thrombotic events in patients with coronary artery disease (CAD), showing a reduction in adverse events.

The objectives of this study are To establish a prospective registry of the whole patients who received percutaneous coronary intervention with Xience Xpedition™/Alpine™ stent To evaulate the long-term efficacy and safety of coronary stenting with the Xience Xpedition™/Alpine™ stent To compare the long-term efficacy and safety of coronary stenting between the Xience Xpedition™/Alpine ™ stent and other contemporary drug-eluting stents which had established their own registry

Although atherosclerosis is a systemic disease, its manifestations are focal and eccentric, and each coronary obstruction progresses, regresses, or remains quiescent in an independent manner. The focal and independent nature of atherosclerosis cannot be due solely to the presence of systemic risk factors such as hyperlipidemia, diabetes mellitus, cigarette smoking, and hypertension. Local factors that create a unique local environment are a major determinant of the behavior of atherosclerosis in a susceptible individual. The vascular endothelium is in a unique and pivotal position to respond to the extremely dynamic forces acting on the vessel wall due to the complex 3-D geometry of the artery. Mechanical forces in general, and fluid shear stress (endothelial shear stress [ESS]) in particular, elicit a large number of humoral, metabolic and structural responses in endothelial cells. Regions of disturbed flow, with low and oscillatory ESS (< 1.0 Pa), are intensely pro-atherogenic, pro-inflammatory, and pro-thrombotic, and correlate well with the localization of atherosclerotic lesions. These sites demonstrate intense accumulation of lipids, inflammatory cells, and matrix degrading enzymes which promote the formation of high-risk thin-cap fibroatheroma. In contrast, physiologic laminar flow (1.0-2.5 Pa) is generally vasoprotective. However, as the obstruction progresses and further limits blood flow through a narrowed lumen, flow velocity and ESS may increase excessively (> 2.5 Pa) at the neck, and decrease abnormally at the outlet, increasing the likelihood of platelet activation and thrombus formation. Identification of an early atherosclerotic plaque likely to progress and acquire characteristics leading to likelihood of rupture and, consequently, to precipitate an acute coronary event or rapid luminal obstruction, would permit more definitive pharmacologic or perhaps mechanical intervention prior to the occurrence of a cardiac event. The potential clinical value of identifying and "eradicating" plaques destined to become vulnerable before they actually become vulnerable is enormous. The purpose of the PREDICTION Trial is to identify high-risk coronary lesions at an early time point in their evolution, to follow the natural history of these lesions over a 6-10 month period, and to confirm that these high-risk lesions are likely to rupture and cause an acute coronary syndrome (ACS) or develop rapid progression of a flow-limiting obstruction. The hypothesis is that local segments in the coronary arteries with low ESS and excessive expansive remodeling will be the sites where atherosclerotic plaque develops, progresses, and becomes high-risk, leading to a new cardiac event. This study is being conducted in Japan as patients are clinically evaluated with followup coronary angiography and IVUS in a routine manner at 6-10 months following their initial percutaneous coronary intervention (PCI) for an ACS. This is a natural history and a clinical outcomes study in patients who initially present with an ACS. The natural history portion of the study is designed to describe the temporal progression of atherosclerosis in segments of coronary arteries with low ESS and expansive remodeling using intracoronary vascular profiling techniques utilizing intravascular ultrasound (IVUS) and coronary angiography. The clinical outcomes portion of the study is designed to evaluate the efficacy of coronary vascular profiling to predict segments of coronary arteries that will become areas of rapid plaque growth or rupture leading to recurrent major clinical coronary events. Five hundred (500) patients with acute coronary syndrome undergoing PCI for a culprit lesion are to be enrolled in the study to undergo coronary vascular profiling at the time of the index catheterization procedure. Up to 374 consecutive patients with at least one low ESS subsegment are to have follow-up coronary angiography and IVUS at 6-10 months to allow for at least 300 patients with analyzable intracoronary vascular profiling data for assessment of lesion natural history. All patients are to have a one-year clinical follow-up to assess for new cardiac events, followed by two additional years of extended clinical followup.