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Showing 1-13 of 13 trials
NCT07548554
Despite all advances in diagnostic and therapeutic methods over the past century, ischemic heart disease (IHD) remains a leading cause of mortality and morbidity worldwide. IHD develops as a result of reversible or irreversible impairment of myocardial perfusion in acute or chronic settings. This perfusion abnormality most commonly arises from compromise of epicardial coronary artery patency due to stenosis, occlusion, or vasomotor abnormalities. Structural and/or functional alterations in the microcirculation may also contribute to impaired myocardial perfusion. Conditions in which myocardial perfusion is acutely compromised are classified as acute coronary syndromes (ACS), whereas reversible ischemia developing on a chronic basis is evaluated under the umbrella of chronic coronary syndromes (CCS). In the assessment of epicardial (macrovascular) or microvascular pathologies leading to ischemia in CCS, angiography, a macroscopic lumenographic method, is often insufficient. Intracoronary pressure and flow measurements are required to determine the impact of angiographically detected epicardial lesions on coronary blood flow, perfusion pressure, and consequently myocardial perfusion. These measurements are referred to as invasive intracoronary physiology (IIP). Current guidelines recommend that decisions regarding revascularization of intermediate epicardial lesions should be based on IIP. Revascularization guided by IIP is associated with reduced mortality and morbidity, along with a lower stent burden. IIP can be performed using pressure-based, flow-based, or combined strategies. Recent multinational studies indicate that strategies integrating both flow and pressure parameters achieve better clinical outcomes with fewer interventions and reduced stent implantation compared to pressure-only approaches. Indeed, in cases where coronary flow and flow reserve are preserved, abnormalities in pressure parameters alone may not justify revascularization. Nevertheless, lesions deemed not to be associated with reversible ischemia based on IIP may still pose a risk due to plaque erosion/rupture and subsequent thrombotic cascades that can acutely compromise the lumen. Many acute coronary syndromes arise from lesions that are hemodynamically insignificant (i.e., do not affect flow) and unrelated to reversible ischemia in the CCS setting, but which undergo sudden near-total or total occlusion. The histopathological characteristics of any coronary lesion can be evaluated using intracoronary imaging techniques. Intracoronary Optical Coherence Tomography (IC-OCT) is a high-resolution, real-time imaging modality that quantitatively assesses lipid-rich plaque content, evaluates the thickness and stability of the fibrous cap separating this content from the lumen, and provides detailed information regarding minimal lumen area, lesion morphology, surface characteristics, presence of erosion, and plaque vulnerability to rupture. IC-OCT can identify lesions that are hemodynamically insignificant yet may benefit from revascularization and have the potential to cause ACS. Combined evaluation using IC-OCT and IIP enables an integrated assessment of both the relationship with chronic reversible perfusion impairment and the risk of precipitating ACS for each lesion and coronary segment, thereby facilitating optimal revascularization strategies. Despite the available evidence and guideline recommendations in CCS, the use of IC-OCT and IIP in the context of ACS remains limited due to procedural challenges and variability in practical application. These methods are not routinely recommended in guidelines and, in some cases, are even discouraged. However, the optimal strategy for revascularization of non-culprit lesions in ACS remains uncertain, and no consensus has yet been established. Patients with ACS are at increased risk for recurrent events arising from all coronary lesions. Therefore, accurate evaluation and preventive revascularization strategies for these lesions are expected to provide substantial benefit. Our study aims to reclassify and characterize non-culprit lesions in patients with ACS using combined IC-OCT and IIP assessment.
NCT07514988
This study aims to investigate and compare the local inflammatory responses and plaque healing characteristics between sirolimus-coated and paclitaxel-coated coronary drug-coated balloons in patients with acute coronary syndrome.
NCT07276256
This study looks at people who come to the hospital with acute coronary syndrome, a serious heart condition. When these patients first arrive, doctors take routine blood tests. The investigators use these test results to calculate a value called the leukoglycemic index (LGI), which combines white blood cell count and blood sugar level. The investigators also use a heart imaging score called the SYNTAX score to see how complex their coronary artery disease is. Patients are divided into two groups based on their SYNTAX scores: one group with lower scores (22 or less), and one with higher scores (above 22). The investigators compare their health data to see if LGI is linked to the severity of their heart disease. The investigators also check if LGI can help predict how complex the disease is. Information like age, family history, and chronic illnesses is collected from patient records and medical interviews.
NCT07429227
The prospective experimental study aims to take an instantaneous photograph of the subject at time T0 and after 24 hours of intestinal permeability and dysbiosis indices in patients with acute coronary syndromes (ACS) which include unstable coronary artery disease (unstable angina) and acute myocardial infarction (AMI). The aim is to verify whether essential oils in particular formulations with high bioavailability are able to re-establish intestinal eubiosis after 2 months, confirmed by tests laboratory specifics such as metabolomics.
NCT07107971
The goal of this clinical trial is to find out whether treating vulnerable plaques in the coronary arteries with a drug-coated balloon can make them less dangerous than using standard medication alone. The study includes adults with acute coronary syndrome (a type of heart problem caused by reduced blood flow in the coronary arteries). The main questions the study aims to answer are: * Does the drug-coated balloon reduce the amount of fat inside the plaque more than medication alone? * Is this treatment safe for patients? Participants will: * Undergo imaging of their coronary arteries during their planned heart procedure (PCI) * Be randomly assigned to receive either a drug-coated balloon treatment or no extra treatment * Undergo a heart scan (CT scan of the coronary arteries) within 2 weeks and again around 9 months after the procedure. * Undergo a second heart catherization 9 months later to examine changes in the plaque.
NCT07288502
This study aimed to assess adherence to secondary prevention medications among patients in Nepal following an Acute Coronary Syndrome (ACS) event and to identify factors affecting adherence. ACS was a major cause of morbidity and mortality globally and in Nepal, requiring effective secondary prevention to minimize recurrent cardiovascular events. However, adherence to prescribed medications remained low, especially in low- and middle-income countries like Nepal. Poor adherence could lead to increased healthcare burden, worsened patient outcomes, and higher mortality rates. To address this, the study evaluated patients' medication adherence through the MYMEDS questionnaire, a self-reported tool that was positively received for its simplicity and clarity. Conducted at the Manmohan Cardiothoracic Vascular and Transplant Centre in Nepal, the study involved a sample of adult patients who were readmitted or attending follow-ups post-ACS. The research gathered data on patient demographics, socioeconomic factors, clinical characteristics, and self-reported adherence barriers, analyzing these with SPSS to assess correlations with clinical outcomes. The 12-month project consisted of phases for ethical approvals, data collection, analysis, and report dissemination. By identifying key barriers to adherence, the study aimed to inform targeted interventions that could enhance medication adherence, improve long-term cardiovascular outcomes, and reduce healthcare burdens in Nepal and other similar settings.
NCT06853626
Acute chest pain is a prevalent medical emergency in primary emergency care settings. Triage of chest pain prior to hospital admission presents significant challenges due to the absence of sufficiently sensitive diagnostic tools. Clinical signs, symptoms, risk assessment scores, or a normal electrocardiogram (ECG) can reliably exclude acute myocardial infarction (MI). This diagnostic uncertainty has resulted in chest pain being the second most common cause for acute hospital referrals from Norwegian emergency primary care, even though chest pain is frequently non-cardiac in origin. In acute MI events, cardiac troponins are released into the bloodstream from the damaged myocardium, where low values are used to exclude MI. Until recently, such testing has necessitated using high-sensitivity cardiac troponin (hs-cTn) assays, which have been limited to hospital laboratories. However, recent technological advancements in point-of-care (POC) testing allow access to whole-blood assays that meet high-sensitivity criteria. In this upcoming project, the investigators will evaluate the implementation of a whole-blood POC assay (QuidelOrtho TriageTrue hs-cTnI) across six Norwegian emergency primary care clinics. The study plans to enrol 2,500 patients over a period of 1.5 years. The clinical performance of the novel strategy will be investigated, as well as its impact on healthcare utilization and hospital referrals compared to standard care. Additionally, the investigators will assess the prevalence of persistent chest pain and its effects on quality of life, alongside psychological stress and anxiety, through validated questionnaires. This project aims to offer better and more comprehensive management of the large group of emergency primary care patients with acute chest pain, contributing to reduced hospital referrals, improved quality of life, and more sustainable use of healthcare services.
NCT07192965
Chest pain represents a common reason for consultation to emergency room. This symptom can be explained by a broad spectrum of conditions, from benign musculoskeletal or esophageal pain to life-threatening disease such as aortic dissection, pulmonary embolism, and myocardial infarction. There are already different diagnostic tools to quickly identify most dangerous diseases, for example electrocardiogram, blood samples with specific markers of cardiac injury, chest X-ray and echography. In case a doubt of disease is raised after the first clinical evaluation, it is possible to proceed with more complex, expensive and invasive examinations, namely a computed tomography (CT) scan or an invasive coronary angiography (ICA). CT scan allows the diagnosis of various conditions such as pleural, pulmonary, pericardial and vascular disease such as pneumonia, pneumothorax, pleural and pericardial fluid, pulmonary embolism (PE), acute aortic dissection (AOD). In order to see the pulmonary, aortic and coronary arteries, a contrast injection is needed. Moreover, since the heart and the aortic root are continuously moving, specific technical measures to obtain good quality images are needed. Recently, a new CT scan system has been developed. It allows to obtain good quality images of the heart and aortic root using an estimated heart rhythm, without ECG-gating. This allows to perform a CT scan of the heart in a reduced amount of time, and without need for controlling heart rate. Moreover, it is possible to obtain information on both aortic, coronary, and pulmonary artery with the same contrast injection. This may be of great interest in the context of patients presenting at the emergency room with chest pain and with a suspicion of pulmonary embolism, myocardial infarction, or aortic dissection, since with a single fast exam it is possible to rule out all these conditions. Coronary arteries are very small vessels, and the accuracy of this new technique in identifying a significant obstruction is still to be proved. At present, patients with chest pain and a suspicion of myocardial infarction undergo an invasive coronary angiography. If this new tool proves to be reliable, it will be possible to reduce the number of useless invasive examination in patients in which the presence of coronary artery disease (CAD) is ruled-out. In addition, the CT scan can help quickly and effectively plan treatment when worrying abnormalities are detected in the coronary arteries that are associated with a higher risk. Therefore, this clinical trial (further on referred to as "trial") will evaluate the investigational medicinal product (IMP), ECG-less Revolution Apex Elite system (GE Healthcare, Waukesha, WI -USA) for the diagnosis of coronary artery disease. The purpose of this trial is to learn about: the accuracy of this new CT system compared to the gold standard invasive coronary angiography in diagnosing coronary artery disease. The number of patients receiving an alternative diagnosis such as pulmonary embolism, aortic dissection, pulmonary, pleural or pericardial disease will be evaluated. Finally, the prognostic predictive value of the CT compared with ICA, in predicting myocardial infarction, coronary revascularization, and cardiac death at a follow-up of 18 months will be assessed. Patient will undergo a computer tomography examination with this new technique, evaluating both pulmonary, aortic, and coronary arteries. Then, as indicated by current guidelines, they will undergo an invasive coronary angiography.
NCT07182799
The starring optical coherence tomography during percutaneous coronary intervention guidance (OCT-AGEM) registry aims to evaluate the clinical impact of intra-procedural optical coherence tomography (OCT) in coronary revascularization, both in guiding revascularization decisions and optimizing interventional procedural outcomes, as well as assessing mid- and long-term clinical results.
NCT07038265
The primary objective of this study is to compare an integrated, multidisciplinar patient-centered CRP (Cardiac Rehabilitation Program) (intervention group) especially focused on covering the needs for the female and fragile population to the usual care conventional CRP (control group)
NCT06861582
This clinical study aims to compare two different methods for measuring high-sensitivity troponin I, a key biomarker used to diagnose heart attacks. The primary research question is: Does the use of the Atellica VTLi kit from Siemens for high-sensitivity troponin I (hs-cTnI) testing at the point of care (POC) significantly reduce the average time from admission to hospital discharge compared to the conventional laboratory methodology using the Alinity i kit from ABBOTT? Participant will: * Patients aged ≥ 18 years. * Patients arriving in the emergency room with symptoms suggestive of ACS, with onset of pain between 3 and 12 hours after arrival, in whom serial troponin dosing is planned for investigation. * Signature of the Informed Consent Form (ICF). Researchers will analyze whether the point-of-care testing method helps speed up the hospital discharge process compared to the standard laboratory approach. They will also compare the accuracy of the test results, the time taken for clinical decisions, and the overall cost-effectiveness of the two methods.
NCT06793774
This is a single-center, prospective cohort study. This study is designed to accurately analyze coronary artery plaque characteristics and local hemodynamic parameters in patients diagnosed with chronic coronary syndrome (CCS) or non-ST-segment elevation acute coronary syndrome (NSTE-ACS), with marginal lesions or obstructive lesions in major coronary arteries by multimodality imaging including noninvasive coronary CT angiography (CCTA) and intracoronary imaging techniques, such as intravascular ultrasound (IVUS), optical coherence tomography (OCT), and near infrared spectroscopy (NIRS). The purpose of this study is to improve the accuracy and depth of plaque analysis by CCTA under the guidance of intracoronary imaging, therefore constructing a new CCTA-based high-risk plaque model.
NCT00305162
The primary objective of this study is to demonstrate that the efficacy of cangrelor is superior, or at least non-inferior, to that of clopidogrel in subjects requiring PCI.