Active clinical trials for "Coronary Artery Disease"

Comparison of clinical outcomes between routine angiography follow-up and routine clinical follow-up after percutaneous coronary intervention in high-risk patients.

EVAREST will identify and validate novel blood and imaging biomarkers of potential value for consistent and accurate interpretation of stress echocardiography. During phase one, blood samples will be collected to assess the impact of cardiac stress on levels of circulating biomarkers and examine whether the measurement of these biomarkers can provide additional prognostic information. Phases one, two and three will also determine whether novel imaging biomarkers can be identified in the echocardiograms that can be used for objective interpretation of the stress echocardiograms. EVAREST will recruit up to 8000 patients (First 500 during phase one, an additional 500 during phase two and an additional 7000 during phase three) from multiple hospitals across United Kingdom, who have been referred for a stress echocardiogram as part of their investigations into ischaemic heart disease. Phase four of the study will continue into a clinical study cohort phase to capture information from all patients referred for a stress echocardiogram in the UK, regardless of the reason for investigation.This registry phase will run for 2 years, recruiting up to 15000 participants.

Coronary Computed Tomography Angiogram (CCTA) is a non-invasive imaging modality that has high sensitivity and negative predictive value for the detection of coronary artery disease (CAD). The main limitations of CCTA are its poor specificity and positive predictive value, as well as its inherent lack of physiologically relevant data on hemodynamic significance of coronary stenosis, a data that is provided either by non-invasive stress tests such as myocardial perfusion imaging (MPI) or invasively by measurement of the Fractional Flow Reserve (FFR). Recent advances in computational fluid dynamic techniques applied to standard CCTA are now emerging as powerful tools for virtual measurement of FFR from CCTA imaging (CT-FFR). These techniques correlate well with invasively measured FFR [1-4]. The primary purpose of this study is to evaluate the incremental benefit CT-FFR as compared to CCTA in triaging chest pain patients in emergency settings who are found to have obstructive CAD upon CCTA (generally >= 30% stenosis). Invasive FFR and short term clinical outcomes (90 days) will be correlated with each diagnostic modality in order to evaluate positive and negative predictive value of each. Patients will undergo a CCTA, as part of routine emergency care. If the patient consents to participate in the study, the CCTA study will be assessed by Toshiba Software, to provide a computerized FFR reading, based on the CCTA study. If the noninvasive FFR diagnosis indicates obstructive disease, the patient will undergo cardiac catheterization with invasive FFR. As CCTA utilization increases, the need to train additional imaging specialists will increase. This study will assess the capability of FFR-CT to enhance performance on both negative and positive predictive value for less experienced readers by providing feedback based on CT-FFR evaluation. If the use of CT-FFR improves accuracy of CCTA, as compared to the gold standard, (Invasive FFR), use of CT-FFR can potentially enhance performance for less experienced readers.

Background: Longterm exposure to air pollution has been associated with cardiovascular events and mortality on top of traditional risk factors. Pulmonary inflammation and oxidative stress have been implicated. Brachial (arm) vascular reactivity (flow-mediated dilation FMD) and carotid (neck) artery intima-media thickness (CIMT) are highly reproducible atherosclerosis surrogates, predictive of cardiovascular and stroke outcome. Montelukast is proven safe and effective in alleviating pulmonary inflammation and oxidative stress when used in prevention of asthma episode. Study objectives: To test the hypothesis of pulmonary inflammation and oxidative stress-related vascular dysfunction in PM air pollution. To evaluate the impact of Montelukast treatment as compared with placebo on predictive atherosclerosis surrogates (FMD and IMT). Design: Parallel placebo control, randomized comparative study. Subjects will be randomized to take Montelukast (10mg/daily) or image-matched placebo for 26 weeks. Measures will include PM2.5/PM10, indices of subclinical atherosclerosis (brachial FMD and CIMT), blood inflammatory biomarkers (platelet counts, hsCRP and fibrinogen) and potential confounders (lipids and glucose). Setting: 120 working adults aged 30-60 years in Hong Kong and 80 working adults in Chongqing (CREC Ref No: 2018.157, 2020.398) Main outcome measures: Subclinical atherosclerosis: (a) Endothelial function (brachial FMD) and (b) carotid intima media thickness (CIMT). PM2.5 & PM10 concentrations: real-time measurement by portable devices twice at home and work sites. Blood inflammatory markers-platelet count, hsCRP and Fibrinogen Potential confounders: we shall collect informations on a range of potential confounders, including other air pollutants and traditional risk factors of atherosclerosis, entrusted to be controlled (stable). Expected results: Adults after Montelukast treatment and exposed to high levels of PM2.5 or PM10 would have improved (increased) brachial FMD, and reduction of CIMT as compared with placebo. These will have great implication for comparative vascular epidemiology and development of preventive strategies.

In a prospective multi-center observational study, 200 HIV-infected patients treated with antiretroviral treatment (ART) and who suffered from coronary artery disease (CAD) will be enrolled. Blood samples for biological parameters will be collected with all participants: lipid profile and markers of systemic inflammation specific for HIV-infection (lipopolysaccharide-binding protein; cytokines: IL-1β, IL-6, IL-8, IL-10, TNF -α, INF-γ, INF-α; procalcitonin; inflammatory hsCRP). All of them will undergo functional testing (Echo, CMR both at rest and stress if necessary) and invasive imaging with QCA, FFR, QFR, OCT, IVUS, VH-IVUS, NIRS. Patients will be treated according to the current and previous recommendations. Both medical treatment and percutaneous transluminal coronary angioplasty (PTCA) with or without stenting will be done. Collected data will be analyzed: correlation between ART, blood test results, coronary angiography results, including performed PTCA, history of myocardial infarctions, and other cardiovascular events. The follow-up period will achieve 12 months prospectively with collected clinical events and imaging outcomes which will be determined at the baseline and 12-month follow-up. The independent ethics expertise will be provided by the Central Clinical Hospital of the Russian Academy of Sciences (Moscow, Russia). The monitoring of the clinical data with imaging will be provided by The Ethics Board of Central Clinical Hospital of the Russian Academy of Sciences.

The ICRR is a health services registry to establish the quality of CR delivery, and the effectiveness in terms of patient outcomes, in low-resource settings. The purposes of the registry are care optimization, evidentiary support for CR advocacy / policy, and research. All programs in low-resource settings will be welcome to participate at no cost. Programs will follow procedures approved by their local ethics board for collection of program and patient-reported variables. Assessments occur pre-cardiac rehabilitation (CR), post-CR and annually thereafter.

A prospective, multicenter, 1:1 randomized, investigator initiated study. Goal of this study is to examine the safety of uninterrupted periprocedural NOAC use.

The "DATASET-PRECISE", a 3-arm parallel randomized study, aims to provide new insights in risk stratification of patients with suspected CAD in the Greek population. The convergence of information derived from exercise ECG stress test, CACS, CCTA and metabolomic profiling in artificial intelligence algorithms describes in brief the main objective of this protocol. The design of the present proposal is based on current state-of-the-art literature, incorporating, however, additional innovative elements. It is about the first randomized study to be conducted in Greece, investigating the role of CCTA and CACS in CAD diagnosis and risk assessment. Moreover, the present protocol aims to integrate information on patients' metabolomic profiling. The process of the whole information by using artificial intelligence technology will lead to the development of new risk stratification algorithms, promoting further personalized diagnostic and therapeutic approach. Regarding Greece, this is the first prospectively enrolling medical database of this scale.

An observational study to evaluate safety and efficacy of the hybrid approach DES/DCB in the treatment of long diffuse de novo coronary artery disease

Previous studies demonstrated an association between cognitive deficit and coronary artery disease (CAD; Abete et al., 2014; Deckers et al., 2017) even after controlling for the effects of age and socioeconomic status (Singh-Manoux et al., 2003). A selective, non-amnestic cognitive impairment profile has also been observed in this patient group (Roberts et al., 2010), with executive function as the most vulnerable cognitive domain (Rostamian et al., 2015). Prospective memory and CAD Prospective memory (PM) is another facet of executive function that concerns the realization of an intended action (Kvavilashvili, 1998). In addition to the support from memory system, PM strongly relies on attentional and executive control (Kliegel et al., 2011). For example, the two-stage cue-focused view of PM retrieval (McDaniel et al., 2004) posited the importance of "noticing" an action cue before the associated memory search can be initiated. PM is a clinically relevant psychological construct as the failure has been related to quality of life (Doyle et al., 2012), activities of daily living (Woods et al., 2008) and medication adherence (Zogg et al., 2012). However, little is known about PM function in CAD. Only Habota et al. (2015) reported significant PM deficit in a small group of chronic heart failure patients (N = 19) as compared to healthy controls (N = 24). Therefore, the first aim of the present study is to examine PM performance in people with CAD as compared to their healthy controls. Prospective memory and cardiac function The association between the brain and the heart has long been recognized (Samuels, 2007). However, the mechanism of cognitive impairment in CAD has not been clearly understood. Researchers proposed several contributing pathological routes including increased platelet activity, thrombo-embolic mechanisms or cardiac output reduction (Abete et al., 2014). The neurovisceral integration model (Smith et al., 2017) proposed a hierarchy of vagal control from intra-cardiac and cardiovascular reactions to representation of multimodal prior expectations that involve the cerebral executive control network. Accumulating evidence supported this notion by demonstrating the link between autonomic nervous system (ANS) and behavioral performance, such as the association between heart rate variability (HRV) and cognitive functions (Forte et al., 2019) and its moderating effect of resting pre-ejection time (PEP; Giuliano et al., 2017). Few studies investigated the relationship between autonomic responses and PM. Kliegel et al. (2007) and Rothen et al. (2014) verified that there was an association between increased skin conductance responses (SCRs) and the noticing of PM cues in young adults. More recently, Umeda et al. (2016) found that PM performance was associated with an increase in heart rate upon target presentation and with better interoceptive accuracy in college students. They hypothesized that PM was regulated by cardiac afferent signals that facilitate saliency detection and intention retrieval, which was also mediated by interoceptive accuracy. These preliminary findings suggest close relationship between PM and autonomic functions and provide another aspect of the evidence on the brain-heart connection. However, the methodology adopted in these studies suffered from crude, indirect measures of ANS activity. It is also unclear if the autonomic nervous function compromised by CAD (Montano et al., 2009) would play a role in PM deficit. Hence, the second aim of the present study is to investigate the relationship between PM and cardiac function as measured by HF-HRV (the parasympathetic component) and PEP (the sympathetic component).