Active clinical trials for "Coronary Disease"

The Short-Cut trial is a prospective, investigator-initiated, multicenter, randomized controlled trial that is designed to compare the efficacy of cutting balloon angioplasty vs. intravascular lithotripsy prior to drug-eluting stent implantation in patients with moderate to severely calcified coronary arteries.

Asia is in the midst of an epidemic of diabetes. Epidemiological figures suggest that there are more than 110 million people affected by diabetes in China, with a significant proportion of young adults already affected. With increasingly young age of onset, the financial implications due to productivity loss and health care expenditures are colossal. As a result, prevention of diabetes and diabetic complications has been identified as a top healthcare priority in China. In Chinese, diabetic kidney disease with albuminuria, which reflects widespread vascular damage, is a major predictor for end-stage renal failure, cardiovascular complications and death, and a major contributor to the increased healthcare burden associated with diabetes. There is an immense demand for effective tools which can accurately predict diabetes and diabetic complications. Only few genetic factors have been consistently shown to be associated with diabetic kidney disease or other diabetic complications. Identification of genetic factors or other biomarkers predicting these complications can facilitate early identification of high risk subjects for treatment, as well as provide novel targets for drug treatment. To address this, the investigators plan to utilize both hypothesis-generating whole-genome approach as well as candidate gene-based studies to identify novel genetic, epigenetic factors as well as other biomarkers associated with the development of diabetic cardiovascular and renal complications, as well as other diabetes-related outcomes. The Hong Kong Diabetes Biobank (HKDB) is being established in order to serve as a territory-wide diabetes register and biobank for epidemiological analyses, as well as large-scale discovery and replication of genetic and epigenetic markers, and other biomarkers relating to diabetes, diabetes complications or related outcomes. Subjects will be recruited from diabetes centres across Hong Kong, and will have detailed clinical information collected at the time of written consent and blood taking. Subjects will have detailed assessment of baseline diabetes complications through a structured clinical assessment, and will be prospectively followed up for development of different diabetes-related endpoints, as well as collection of clinical information and causes of hospitalization, along with information on medications and prescription records. This multi-centre cohort and biobank aims to improve our understanding of the epidemiology of diabetes and diabetes complications and related outcomes, as well as provide a unique resource for large-scale biomarker research to advance diabetes care and precision medicine in diabetes.

Patients with chronic coronary syndromes (CCS) diagnosed without significant lesions in invasive coronary angiography (ischemia non-obstructive coronary artery disease - INOCA) represent approximately 50% of all patients with CCS. Results of FAME study clearly showed that evaluation of coronary circulation should not be accomplished only with visual assessment in resting conditions. Current European Society of Cardiology Guidelines of diagnosis and treatment of CCS published in 2019 emphasize the necessity of performing complex coronary physiology assessment. Invasive physiological measurements and vasoreactivity provocative tests emerged as key tools to differentiate between vasospastic angina, microcirculatory angina, overlap of both conditions or non-cardiac disease. According to contemporary literature, identification of heterogeneity of patients with INOCA is crucial for determination of adequate treatment. An appropriate pharmacotherapy has a potential to improve outcomes including grade of angina, quality of life, exertional tolerance and most important - MACCE (major adverse cardiac and cardiovascular events) free survival. However, there is a lack of evidence on each of the subtypes of INOCA especially in those with signs and symptoms of vasospasm in provocative test but without visual spasm in epicardial vessels.

ISACS ARCHIVES network is part of ISACS TC (NCT01218776) health care program. It is a collaborative network of research centers that support the rapid development of new scientific information and analytic tools. The ISACS ARCHIVES network assists health care providers, scientists, and policymakers seeking unbiased information about the outcomes, clinical effectiveness, safety, and appropriateness of health care items and services, particularly prescription medications and medical devices in acute coronary syndromes (ACS).

Invasively measured fractional flow reserve (FFR) has proven to be useful in guiding coronary revascularization. Several studies have shown that it is justified to treat lesions with a value of 0.80 or lower and safe to defer from PCI in lesions with a value of >0.80. Recently, computational fluid dynamics have allowed FFR measurement from coronary computed tomography angiography images (FFRCT) with excellent diagnostic accuracy compared to invasive FFR. FFRCT can also effectively guide revascularization safely deferring patient with FFRCT >0.80 from invasive angiography. In functionally non-significant lesions, computational fluid dynamic models in addition to CT plaque characteristics (low attenuation, positive remodelling, spotty calcification and napkin-ring sign) may be able to predict which lesions will become flow-limiting, causing clinical events in the future. This study will evaluate disease progression in intermediate lesions (invasive FFR 0.81-0.90 at baseline) using FFRCT at 2 years and determine whether CT characteristics may help to identify lesions that are more susceptible for FFR decline. Additionally, we will correlate CT characteristics with coronary events (a composite endpoint consisting of all-cause mortality, target-vessel myocardial infarction and clinically driven target-vessel revascularization) up to 5 years after the baseline invasive FFR.

Background of the study: Percutaneous coronary interventions (PCI) have become mainstay treatment for acute coronary artery disease and the number of patients receiving PCI is vastly growing. However, relatively little long-term follow-up studies of large real-world clinical samples exist that have looked at the real-world effects of PCI treatment and adherence to current guidelines. Psychological risk factors are important in determining prognosis after PCI, and undergoing PCI may increase the risk of low mood. To date, studies have examined single psychological risk factors, without taking into account their relatedness. Moreover, guidelines are advocating psychosocial screening in early cardiovascular disease, but the screening test as proposed in the prevention guideline has not yet been validated or tested. Although the detrimental effects of psychological risk factors on cardiovascular prognosis are known, the mechanisms through which they exert these effects are yet unclear. It is to be expected that not one but multiple biological (inflammation, endothelial dysfunction) and behavioural (coping styles, poor self-care, consultation behaviour) pathophysiological processes play a role, and that these processes interact with each other. In PCI patients the mechanisms linking psychological risk to poor prognosis are still to be investigated. Objective of the study: To examine the adherence to the prevention and PCI guidelines and the effects thereof on long term prognosis in PCI patients. To evaluate the effectiveness of the psychosocial screening instrument of the European Society of Cardiology Prevention guideline 2012. To examine effects of clustering psychological risk factors on several networks of potentially mediating mechanisms and long term outcomes in a large sample of PCI patients.

This is a Multi Center Randomized Control Study of MeRes100 Sirolimus Eluting BioResorbable Vascular Scaffold System in treatment of approximately 484 subjects with Coronary Artery Disease in China. Eligible subjects shall have up to two de novo lesions in different epicardial vessels (One lesion in each coronary artery or it's major branch),Target lesion shall have visually estimated diameter stenosis ≥ 70% (or ≥ 50% and has clinical evidence of myocardial ischemia), lesion length ≤ 24mm, reference vascular diameter visually ≥ 2.75mm and ≤ 4.0mm. And subjects must meet all the study inclusion / exclusion criteria before enrolment in the study.All subjects shall accept clinical follow up at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post procedure.

Coronary artery computed tomographic angiography (CTA) is a widely used, highly accurate technique for the detection of coronary artery disease (CAD), with sensitivity and negative predictive values of over 90% (1-4). Patients with normal CTA findings have an excellent prognosis and do not require further testing for CAD (5). However, like invasive coronary angiography (QCA), CTA is an anatomic test and, unless lesions are very severe (>90% stenosis), cannot reliably predict the impairment of flow (functional significance) of intermediate grade stenoses. For this reason, in approximately 15-25% of patients, additional functional testing may be required after CTA, usually in the form of stress testing (6-8). Stress testing is commonly done by exercise or pharmacologic stress with electrocardiographic monitoring and often, imaging of myocardial perfusion by nuclear scintigraphy (MPI) or detection of abnormal contraction by echocardiography. This requires a separate procedure, entailing time, expense and limited risk. Furthermore, in patients with previously known CAD, CTA alone is not an adequate test, because in most cases there are multiple lesions that are possible sources of ischemia. Over the last 10 years, these investigators and others around the world have developed a method of imaging myocardial perfusion by CT (CTP). This test is an adjunct to the usual Cardiac Computed Tomography Angiography (CCTA) procedure and can be done immediately thereafter, using conventional pharmacologic stress agents. It has demonstrated accuracy in many single center trials, and in this large multicenter study, the CORE320 trial (9,10) which showed a high accuracy in predicting the combined results of QCA plus MPI testing and a second multicenter trial established non-inferiority of myocardial CTP compared with nuclear stress testing (11,12). Additionally, this investigator group has published a direct comparison of diagnostic performance of myocardial CTP imaging and SPECT myocardial perfusion imaging and demonstrated superior diagnostic performance of CTP imaging compared with SPECT for the diagnosis of significant disease on invasive angiography (13). CTP images can be acquired with two different approaches: static or dynamic. In the CORE320 study, the CTP protocol used static acquisition method. The static CTP method, samples a snapshot of the iodine distribution in the blood pool and the myocardium over a short period of time, targeting either the upslope or the peak of contrast bolus. The notion behind this is that, at the upslope of the contrast, the difference in attenuation value of the ischemic and remote myocardium is at the maximum which enables for qualitative and semi-quantitative assessment of myocardial perfusion defects. The static CTP, however, does not allow for direct quantification of the myocardial blood flow (MBF). One of the drawbacks of static CTP lies in the acquirement of only one sample of data and the possibility of mistiming of the contrast bolus that results in poor contrast-to-tissue ratios by missing the peak attenuation (14). Output and flow rate of the contrast material may affect bolus timing. In addition, the acquisition of data from sequential heartbeats affects the attenuation gradient and may result in a heterogeneous iodine distribution, mimicking perfusion defects (15). Furthermore, the static CTP is limited in detection of balanced ischemia, where the perfusion of the entire myocardium is impaired and therefore there is no reference remote myocardium for comparison for semi-quantitative or qualitative static methods of CTP interpretation. Dynamic CT perfusion imaging uses serial imaging over time to record the kinetics of iodinated contrast in the arterial blood pool and myocardium. This technique allows for multiple sampling of the myocardium and the blood pool and creating time attenuation curves (TAC) by measuring the change in CT attenuation over time. Mathematical modelling of TACs permits for direct quantification of MBF. Despite its advantages, the use of dynamic CTP were limited in the past. A high temporal resolution and high number of detectors are required for dynamic CTP to allow for entire myocardial coverage, and in order to obtain multiple consecutive images at high heart rates(16,17). But the main challenge of dynamic CTP acquisition was the high radiation dose associated with this technique. Nevertheless, with the introduction of the cutting-edge 320 detector CT scanning systems with fast gantry rotation the issue of the cardiac coverage is eliminated(17). The second-generation 320-row scanners also permit the quantification of the MBF with dynamic CTP acquisition with relatively low-dose of radiation(18,19). In this study the investigators aim to evaluate the feasibility, safety and accuracy of the low-radiation dose dynamic myocardial CT perfusion compared to static CTP approach to detect hemodynamically significant coronary artery disease.

The FUTURE-III study is a confirmative clinical trial for Sirolimus Target Eluting Bioresorbable Vascular Scaffold (Firesorb) after the feasibility and safety of the device has been preliminary confirmed in a small-scale First-in-Man clinical trial.

A prospective, multicenter, registered cohort study to observe the incidence of 1-year major adverse cardiac events in patients with coronary heart disease co-morbid depression treated with percutaneous coronary intervention and to clarify the predictors of 1-year major adverse cardiac events post PCI among these patients.