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NCT04951856
AMUNDSEN-real is a phase IV, international (7 European countries), multicenter, controlled, open label study randomized, in 2 parallel groups of patients with a diagnosis of STEMI or NSTEMI with an indication for PCI, using the PROBE study design (Prospective Randomised Open, Blinded Endpoint). The objective of this study is to demonstrate the superiority of evolocumab versus standard of care in reaching a LDL-C reduction of ≥ 50% from baseline and a LDL-C goal of \<1.4 mmol/L (\<55 mg/dL) at 12 months follow-up on the overall population. The primary clinical objective is to demonstrate the superiority of evolocumab versus standard of care on the composite endpoint of death or any unplanned hospitalization for a CV reason at 12 months. Central randomization uses an IWRS. Stratification is by center and stratum with random block size, generated according to the procedures of the sponsor, by a statistician not involved in the study.
NCT07257198
In patients with a myocardial infarction (MI) treated medically alone, the objective of the PANTHEON trial is to evaluate if ticagrelor monotherapy reduces bleeding events, without an increase in patient-oriented ischemic events, compared with standard dual antiplatelet therapy (DAPT) with aspirin and ticagrelor for 12 months.
NCT07343076
This is a prospective, multi-center, randomized controlled, open-label, blinded endpoint assessment study. The objective is to compare the 1-year incidence of major adverse cardiovascular and cerebrovascular events (MACCE) between two treatment strategies-immediate complete revascularization and staged complete revascularization-in NSTE-ACS patients with multivessel disease (MVD). NSTE-ACS patients who meet other the inclusion and exclusion criteria will be randomized into the following two groups after signing an informed consent form: Intervention group Immediate Complete Revascularization: Emergency PCI for the culprit vessel is performed successfully, and simultaneous PCI is conducted for non-culprit vessels that meet the defined criteria (visually estimated diameter ≥2.5 mm, eligible for successful PCI, and visually estimated maximum diameter stenosis ≥ 70% or positive coronary physiology testing). Control group During emergency intervention, PCI is performed only on the culprit vessel. Elective PCI is then conducted for non-culprit vessels that meet the defined criteria (visually estimated diameter ≥ 2.5 mm, eligible for successful PCI, and visually estimated maximum diameter stenosis ≥ 70% or positive coronary physiology testing)-either during the current emergency hospitalization or within 6 weeks after the culprit vessel PCI.
NCT07368933
The study objectives are: 1. To evaluate the safety and performance of the SirPlux Duo PTCA to treat coronary ISR lesions 2.00-4.00 mm (inclusive) in diameter in patients with symptomatic coronary artery disease. 2. To evaluate the safety and performance of the SirPlux Duo PTCA to treat coronary de novo lesions \<3.00 mm in diameter in patients with symptomatic coronary artery disease.
NCT06927791
The research project aims to develop clinical decision support tools integrating established diagnostic variables and machine learning (ML) models for rapid diagnosis of acute life-threatening cardiovascular conditions in emergency department (ED) patients with chest pain or dyspnea with the ultimate goal of Improved diagnostic accuracy, faster patient management, and reduced medical errors.
NCT04163484
The goal of the study is to assess the prevalence of contrast-associated acute kidney injury in patients with stable coronary artery disease, ST-elevation myocardial infarction and unstable angina/NSTEMI, assess the risk factors of contrast-induced acute kidney injury development and the influence of contrast-induced kidney injury on 1-year prognosis.
NCT05243485
With the Emergency Medical Services (EMS), no prehospital risk stratification and triage is performed for patients suspected of having an Non-ST-segment elevation Acute Coronary Syndrome (NSTE-ACS). While the latest ESC Guidelines recommend an early invasive strategy within 24 hours for all high risk NSTE-ACS patients and same-day transfer to a PCI (Percutaneous Coronary Intervention) center. With the potential emerging logistical problem surrounding this, prehospital risk stratification and triage can have great benefits in this population as well, especially in patients with a high risk of having an NSTE-ACS. The recently validated PreHEART score makes it possible to stratify patients in a low-risk and high-risk group for having a NSTE-ACS and gives the EMS the opportunity to make triage decisions in the prehospital setting. Patients with a high risk for having an NSTE-ACS are transferred directly to an PCI-center for further diagnostic work-up. Patients with a low risk for having NSTE-ACS and transferred to the ED of the nearest hospital without PCI facilities (non-PCI center) for further diagnostic work-up, resulting in an optimization of the regional care utilization. This is the first study to focus on patients who are at a high risk of having an NSTE-ACS and to assess if whether prehospital triage using the PreHEART score is able to significantly reduce time to final invasive diagnostics and revascularization in patients in need of coronary revascularization.
NCT05218005
ACCURATE will test the hypothesis that opportunistic genetic testing for Familial Hypercholesterolemia (FH) in patients admitted to hospital with an acute coronary syndrome will increase the diagnosis of FH and will impact patient care and outcomes. The study will recruit patients admitted to hospital with an acute coronary syndrome, and research-based genetic testing will be conducted for known FH-causing genetic variants. The results will be returned to the patients' treating physicians. The primary endpoint will be the number of patients with a new diagnosis of FH. The secondary endpoints will be the proportion of patients who undergo intensification of lipid-lowering therapy, the lowest LDL cholesterol level achieved, and the proportion of patients reaching guideline recommended lipid targets in the 12 months after the index acute coronary syndrome.
NCT04231097
Brief Summary: The aim of this study is to explore the initial feasibility and acceptability of (a) Mindfulness-Based Cognitive Therapy (MBCT) adapted for ACS patients; (b) the group videoconferencing delivery medium; and (c) dried blood spot research procedures, to inform refinements for a subsequent pilot RCT.
NCT03138473
The investigators want to assess the use of the residual SYNTAX score and the SYNTAX Revascularization Index as predictors for in-hospital outcomes and mid-term (6 months to 1 year) outcomes in patients with multi-vessel disease (MVD) who undergo PCI in the setting of STEMI or NSTEACS. Both values will be calculated in a number of patients over one year, and the relationship between both values and patient outcomes will be evaluated.
NCT04648306
A multi-center, prospective, observational, non-interventional single arm, study of the intermediate-term clinical outcomes collected from electronic health records of high-risk patients which have previously undergone standard of care prophylactic Impella support for a non-emergent percutaneous coronary intervention (PCI).
NCT04090281
The study aims to determine the feasibility and clinical utility of incorporating precision medicine approaches, incorporating both cytochrome P450 2C19 (CYP2C19) genotyping and platelet reactivity phenotyping, with standard of care for patients with acute coronary syndromes (ACS), post PCI.
NCT03189901
There are always poor outcomes in patients with acute myocardial infarction(AMI) combined with elevated BNP/NT-proBNP level. An elevated BNP/NT-proBNP level highly indicates acute heart failure(AHF).Levosimendan is recommended in many clinical trials of heart failure and Chinese heart failure guidelines. As a result, the investigators form a hypothesis that when patients with AMI combined with elevated BNP/NT-proBNP level are in conditions before AHF, to use levosimendan may reduces the risk of heart failure and improve the outcome.
NCT04146701
"MEtabolomics and MicrObiomics in caRdIovAscular diseases Mannheim (MEMORIAM) " is a single-center, prospective and observational study investigating to identify disease-specific metabolic, respectively microbiomic, patterns of patients with high-risk cardiovascular diseases. High-risk cardiovascular diseases comprise patients suffering from acute heart failure (AHF), ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI), sepsis, septic shock, ischemic and non-ischemic cardiomyopathy.
NCT04289012
The aim of this study is to determine the prevalence of Helicobacter pylori (Hp) infection in patients with myocardial infarction (MI). This is performed to establish the feasibility of a large trial examining whether systematic screening for and subsequent eradication therapy significantly reduces the risk of hospitalization for upper gastrointestinal (GI) bleeding in patients after MI.
NCT04369534
The specific goal of this study is to determine whether the individualized approach and adjusting the dosage of the P2Y12 receptor inhibitors will improve the platelet inhibiton and the clinical outcome in patients with an ACS, that were treated with PCI and the aforementioned drugs, but with an increased initial residual platelet activity. It is expected that the patients that have undergone the P2Y12 inhibitor therapy adjustment (according to the platelet reactivity measured by POC devices) will have better clinical outcomes (ie less ischemic events, without a significant increase in bleeding events) than those who did not undergo the therapy adjustment.