153 Clinical Trials for Various Conditions
The goal of this study is to assess the benefit to physicians and patients of adding an integrated risk score (IRS) to existing coronary artery risk tools by conducting a randomized prospective study. IRS combines both an individual's coronary artery disease (CAD) polygenic risk score (PRS) and clinical risk factors, like cholesterol levels and age. This study will examine to what extent IRS knowledge impacts physician/provider behavior as well as clinical outcomes including cholesterol levels and incident heart disease.
The purpose of this study is to assess the engagement and usefulness of Care4Today® Connect CAD-PAD digital platform in participants with coronary artery disease or peripheral artery disease (CAD or PAD).
The purpose of this study is to see if reducing the number of hours during which one eats each day will help reduce levels of LDL cholesterol and improve other markers of metabolic and cardiovascular health (i.e. blood sugar levels and blood pressure). The study also aims to assess changes in exercise capacity and trimethylamine N-oxide (TMAO) levels in response to Time Restricted Eating (TRE) and Intensive Cardiac Rehabilitation (ICR) versus ICR alone. TMAO is a metabolite, or a substance, produced during digestion and metabolism. Preliminary data illustrates a correlation between high levels of TMAO and higher risk of cardiovascular disease and mortality. We will also be looking at participants' long-term cardiovascular health status after they complete the ICR program.
This single-center clinical trial is designed to evaluate the CardioFlux magnetocardiograph diagnostic imaging system to predict major adverse cardiac events (MACE) in patients referred for evaluation for coronary artery disease.
This is a Phase 3, prospective, open-label, international, multicentre study of Flurpiridaz (18F) Injection for PET MPI in patients referred for ICA because of suspected CAD.
This study will compare how well a new radiolabeled imaging agent ECDG compares to the current testing for coronary artery disease (radiolabeled Sestamibi) during a rest and stress cardiac test as documented from results of a coronary angiogram (if performed).
Subjects being evaluated for suspected or known Coronary artery Disease (CAD) based on signs and/or symptoms, will be invited to participate in the study. The duration for a subject in the study may range from 2 days to 4-6 weeks. One to four visits to the study doctor will be required. The primary objective of this study is to demonstrate that sensitivity and specificity of gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) exceed pre-specified minimum performance thresholds of 60% and 55%, respectively, and to show superior sensitivity over unenhanced wall motion CMRI at vasodilator rest/stress for the detection of significant CAD. The CMR images acquired with a uniform imaging acquisition software will be evaluated either against the results from routine clinical Coronary Angiography (CA) or Computed Tomography Angiography (CTA), which are the standard of reference. CMRI and CA/CTA images will be collected for an independent image review (blinded read).
Participants being evaluated for suspected or known Coronary artery Disease (CAD) based on signs and/or symptoms, will be invited to participate in the study. The duration for a participant in the study may range from 2 days to 4-6 weeks. One to four visits to the study doctor will be required. This study will investigate the diagnostic results of gadobutrol-enhanced Cardiac Magnetic Resonance Imaging (CMRI) images regarding the detection (sensitivity) and exclusion (specificity) of coronary artery disease utilizing a uniform image acquisition software. The CMR images will be tested either against the results from routine clinical Coronary Angiography (CA) or those from Computed Tomography Angiography (CTA), which is used as the standard of reference. The CA/CTA may have been performed up to 4 weeks prior to enrollment or be scheduled up to 4/6 weeks after the study. CMRI and CA/CTA images will be collected for an independent image review (blinded read).
This study will assess the safety and tolerability of the investigational radiolabeled imaging agent technetium-99m-labeled ethylenedicysteine-deoxyglucose (99mTc-EC-DG). Additionally, the study will determine the specific times to best image the heart using a SPECT camera with the investigational imaging agent and compare the images to those taken while undergoing the standard rest and exercise/regadenoson testing previously performed to detect the presence and severity of Coronary Artery Disease (CAD).
Patients with a low blood count (anemia) with stable or unstable coronary artery disease consistently show worse clinical outcomes. It is unclear whether this association is confounded since anemic patients tend to be also sicker i.e. have lower ejection fractions or more comorbidities and this would be the reason for the worse outcomes rather than anemia. The coronary arteries are a unique vascular bed insofar that across the cardiac circulation oxygen extraction is close to maximal at rest. Thus increases in demand can only be met by increases in blood flow and hemoglobin concentration since oxygen extraction is maximal at rest. It is natural to assume that maximization of oxygen delivery in the setting of active coronary syndrome (ACS) is beneficial to the patient since oxygen extraction and coronary blood flow is fixed. In fact, in most intensive care units patients with ACS are transfused to a HCT of 30%. However, retrospective analysis of trial data showed at best mixed results in clinical outcome when patients with ACS were transfused and in fact in some studies showed consistently worse outcomes than non-transfused patients. Similar disappointing results have recently published in patient who underwent coronary artery bypass grafting (CABG). This study is designed to determine the effect of red blood cell (RBC) transfusion on oxygen consumption, cardiac, microcirculatory and endothelial function in patients with active coronary artery disease. For this study active coronary artery disease will be defined as the patient having undergone within the past 4 days of recruitment either a myocardial infarction due to atherothrombosis (AHA type I myocardial infarction) or surgery for coronary artery bypass grafting. In specific this study will test the hypothesis whether RBC transfusions improves cardiac and vascular function in patients with a hematocrit of less than 30% with active coronary artery disease. Aims of this study are to determine whether RBC transfusion in patients with active coronary artery disease and anemia: * increases oxygen delivery to the peripheral tissues. * increases whole-body oxygen consumption. * decreases nitric oxide bioavailability, endothelial, microcirculatory, and myocardial function, and/or increases platelet aggregation
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.
This long-term study will follow patients with known or suspected of having coronary artery disease (CAD) and have participated in present and future BMS747158 clinical studies. The purpose of this study is to evaluate the long-term predictive value associated with BMS747158 Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI).
The aim of this study is to determine the effects of extreme fitness in women. The incidence of coronary artery disease observed via multislice computed tomography (MSCT) angiogram will be compared with age and risk-matched controls from both sedentary and fitness activity groups who have never been significant runners. Life style, training volume and risk factors will be assessed.
To evaluate the impact of left ventricular (LV) lead location on LV mechanical function.
The purpose of this study is to compare the prevalence and severity of CAD (coronary artery disease) in patients with and without severe psoriasis, otherwise matched for cardiovascular risk factors.
The purpose of this study is to evaluate the effect of DHEA on endothelial dysfunction in patients with systemic lupus by measuring: 1. changes in brachial artery flow-mediated dilatation (FMD) and 2. changes in biomarkers of cardiovascular risk. Patients will be enrolled in a randomized, double-blinded crossover trial of DHEA or placebo for ten weeks, then crossed over to the alternate treatment arm after a six-week washout period. HYPOTHESIS: Dehydroepiandrosterone (DHEA) administration in premenopausal women with SLE modifies cardiovascular risk by improving vascular endothelial function and other biomarkers associated with cardiovascular heart disease.
The GAMEFILM Registry is a post-market, multi-center, data collection study assessing the presence of CAD in NFL alumni.
The FORWARD CAD IDE Study is a Prospective, Multicenter, Single-Arm, Investigational Device Exemption (IDE) Study conducted to assess the safety and effectiveness of the Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Coronary IVL Catheter for the treatment of calcified, stenotic de novo coronary artery lesions prior to stenting.
Patients on dual antiplatelet therapy )aspirin plus a P2Y12 inhibitor \[clopidogrel, prasugrel, or ticagrelor\]) undergoing screening or surveilance colonoscopy are at increased risk for bleeding from the procedure. Patients are ussually asked to stop the P2Y12 inhibitor for the procedure. Currently, recommendation is that patients only on a P2Y12 inhibitor be changes to aspirin for the procedure. This pilot study will evaluate if there is a large difference in bleeding between patients only taking aspirin compared with patients only taking a P2Y12 inhibitor. Patinets who participate will randomly be randomly asked to stop either aspirin or the P2Y12 inhibitor 1 week before the procedure. Periprocedural bleeding and bleeding after the procedure for iup to 30 days.
The purpose of this study is to compare the pharmacodynamic effects of ABCD-GENE guided vs. unguided de-escalation strategies among patients on dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI).
This was a Phase 2 prospective, randomized, crossover study of Flurpiridaz (18F) Injection for PET-MPI in participants referred for evaluation of known coronary artery disease (CAD) or for suspected CAD with intermediate to high pre-test probability (PTP). The objective is to assess the difference and variability between 2 sets of rest images synthesized by the same or 2 different manufacturing processes. Twenty-eight evaluable \[participants were enrolled in this study and underwent 2 Flurpiridaz (18F) Injection PET-MPI at rest. Each participant attended a Screening Visit at least 2 days and up to 14 days prior to the first Flurpiridaz (18F) Injection PET-MPI. The participants were randomized 1:1:1:1 to 4 possible sequences of receiving 2 doses of Flurpiridaz (18F) Injection: 2 groups of 7 participants received 2 Flurpiridaz (18F) Injection doses synthesized by the same manufacturing processes (either HPLC or SPE) and 2 groups of 7 subjects will receive 2 Flurpiridaz (18F) Injection doses synthesized by different manufacturing processes (1 dose by HPLC followed by 1 dose by SPE or 1 dose by SPE followed by 1 dose by HPLC). All participants were followed up by telephone for adverse events (AEs) and serious AEs (SAEs) at 24 (+8) hours following each Flurpiridaz (18F) Injection administration.
To evaluate the effect of evolocumab on fibrous cap thickness (FCT) in participants with non-ST-elevation acute coronary syndrome (NSTE-ACS) who are taking maximally tolerated statin therapy.
The investigators hypothesize that the orbital atherectomy system (OAS), a newer generation atherectomy device, reduces the incidence of microcirculatory compromise as compared to older generation rotational atherectomy (RA) due to differences in the mechanism of athero-ablation.
Both intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are standardly used and have been extensively studied separately to guide percutaneous coronary intervention and improve long-term outcomes. In this study, the investigators aim to directly compare high-definition IVUS images to OCT in the same patients to determine the differences between each modality as they relate to imaging coronary pathology, with the goal of determining which modality is most appropriate in particular clinical scenarios.
The MyoVista system is a novel electrocardiogram technology that provides non-invasive assessment of myocardial abnormalities by analyzing energy changes at the cellular level of the myocardium.
There are two separate objectives in this study: 1. To demonstrate the pharmacodynamic (PD) profile when participants treated with cangrelor are switched to oral prasugrel 60 mg administered 30 minutes (min) after cangrelor infusion is discontinued 2. To demonstrate the PD profile when participants treated with cangrelor are switched to oral clopidogrel 600 mg administered during or immediately after cangrelor infusion.
THis study is intended to provide contemporary data on the burden of disease in patients 1 to 3 years post-MI, including a description of patient characteristics, current treatment patterns, rate of major CV events, and healthcare resource utilization in a 'real world' patient population at high atherothrombotic risk.
The purpose of this study is describe the frequency of chest pain and how chest pain impacts patients' quality of life in the outpatients with chronic coronary artery disease in contemporary cardiology practice settings.
The purpose of this study is to demonstrate that the strength of agreement between single photon emission computed tomography (SPECT) imaging with regadenoson following inadequate exercise stress testing and SPECT imaging with regadenoson alone is not inferior to the strength of agreement between two sequential regadenoson SPECT images without exercise.
A prospective, multi-center, single-arm study to establish the safety and effectiveness of the XIENCE V® Everolimus Eluting Coronary Stent, XIENCE nano™ Everolimus Eluting Coronary Stent, XIENCE PRIME™ LL Everolimus Eluting Coronary Stent, HT PROGRESS and HT PILOT Coronary Guide Wires, and MINI-TREK Coronary Dilatation Catheter in patients undergoing elective percutaneous revascularization of native chronic total coronary occlusions