A Comparison of Prasugrel at PCI or Time of Diagnosis of Non-ST Elevation Myocardial Infarction...
Acute Coronary SyndromesThe purpose of this trial is to investigate the potential benefits/risks regarding pretreatment with prasugrel in non-ST-elevation myocardial infarction (NSTEMI) participants with elevated troponin scheduled for coronary angiography/percutaneous coronary intervention (PCI).
Randomized Trial of Immediate Versus Early and Selective Invasive Percutaneous Coronary Intervention...
Myocardial InfarctionIn non-ST-elevation the optimal time of percutaneous coronary intervention (PCI) is unclear. Some studies showed benefit of very early PCI, some others early PCI between 12-48 hours and others even showed a benefit of a selective invasive approach only in case of recurrence of symptoms or a positive stress test. The optimal timing of intervention is still matter of debate as a result of a randomized clinical trial.
Assessing the Efficacy of CardiOGoniometry (CGM) to Localise the Culprit Vessel in Mixed Vessel...
Acute Coronary SyndromeThis study aims to test the hypothesis that cardiogoniometry (CGM) is helpful to identify the site of the culprit vessel in patients with NSTEMI in comparison to 12-lead ECG. NSTEMI constitutes a clinical syndrome subset of acute coronary syndrome which is most usually caused by atherosclerotic coronary artery disease. It is defined by "electrocardiographic (ECG) ST-segment depression or prominent T-wave inversion and/or positive biomarkers of necrosis (e.g., troponin) in the absence of ST-segment elevation and in an appropriate clinical setting (chest discomfort or angina equivalent)". The standard 12 lead ECG is not commonly sensitive at localising the site of the culprit lesion and even coronary angiography may not always be helpful as the majority of lesions will not have angiographically evident thrombus. Patients with an ACS may have multivessel disease and it is often not possible to identify the precise site of the culprit lesion. In patients with multivessel disease, interventionists will frequently target the most severe stenosis even though this is not necessarily the acute lesion. CGM (Cardiogoniometry cardiologic explorer, Enverdis GmbH medical solutions, Germany) is a form of 3D vector electrocardiography which can provide quantitative analysis of myocardial depolarisation and repolarisation. It has CE mark and has been shown to be more sensitive and specific than standard 12-lead ECG at diagnosing stable coronary artery disease. Furthermore, recent work has shown CGM to be more sensitive at detecting patients with NSTEMI than conventional 12-lead ECG In summary, there is evidence that CGM is more efficacious than 12-lead ECG at the diagnosis of both stable CAD and ACS. The hope is this that the clinical application can be extended to localising ischaemia in the culprit vessel and be a valuable diagnostic aid. The primary objective of this study is to investigate the efficacy of CGM to identify the culprit vessel in patients presenting with NSTEMI. Secondary endpoint will be to evaluate the efficacy of CGM to detect a significant coronary stenosis (defined as ≥70%) as compared to a standard 12-lead ECG
The Supplementary Role of Non-invasive Imaging to Routine Clinical Practice in Suspected Non-ST-elevation...
Chest PainMyocardial Infarction3 moreApproximately half of patients with acute chest pain, a very common reason for emergency department visits worldwide, have a cardiac cause. Two-thirds of patients with a cardiac cause are eventually diagnosed with a so-called non-ST-elevation myocardial infarction. The diagnosis of non-ST-elevation myocardial infarction is based on a combination of symptoms, electrocardiographic changes, and increased serum cardiac specific biomarkers (high-sensitive troponin T). Although being very sensitive of myocardial injury, increased high-sensitive troponin T levels are not specific for myocardial infarction. Invasive coronary angiography is still the reference standard for coronary imaging in suspected non-ST-elevation myocardial infarction. This study investigates whether non-invasive imaging early in the diagnostic process (computed tomography angiography (CTA) or cardiovascular magnetic resonance imaging (CMR)) can prevent unnecessary invasive coronary angiography. For this, patients will be randomly assigned to either one of three strategies: 1) routine clinical care and computed tomography angiography early in the diagnostic process, 2) routine clinical care and cardiovascular magnetic resonance imaging early in the diagnostic process, or 3) routine clinical care without non-invasive imaging early in the diagnostic process.
DLBS1033 for Acute NSTEMI Without Early Coronary Revascularization
Acute Non-ST Elevation Myocardial InfarctionThis is a prospective, randomized, double-blind, double-dummy, and controlled study of DLBS1033 in the management of acute non-ST elevation myocardial infarction (NSTEMI) without early coronary revascularization. It is hypothesized that the combination of DLBS1033 with aspirin and clopidogrel will result in greater reduction of infarct size in comparison with that of aspirin and clopidogrel alone.
COlchicine Improve EnDothElial Function in Non ST Elevation Myocardial Infarction Patients
NSTEMIColchicine has antiinflammatory properties. It has been shown to be effective in improving outcome in stable coronary disease. The exact mechanism is unclear. Study objective: to assess the effect of colchicine on endothelial function using the EndoPAT™ in NSTEMI Patients. Study Hypothesis: There will be a significant difference on the RH-PAT levels of the patients who were in treated with colchicine versus the placebo group Study design and patient Selection One hundred and forty patients with the diagnosis of Non ST Elevation Myocardial Infarction will be enrolled to a prospective randomized double-blind placebo controlled study in Tel Aviv Medical Center, Tel Aviv, Israel. Patients will be recruited during their hospitalization before cardiac catheterization. All patients will sign an informed consent. Primary outcome will be the improvement in endothelial function between baseline and after 1 month in both groups
Risk Stratification of Non ST Elevation ACS With Computed Tomographic Angiography (REACT)
Acute Coronary SyndromeNon-ST-Elevation Myocardial Infarction1 moreThe purpose of this project is to examine the effectiveness of computed tomographic angiography (CTA) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS). People who are hospitalized with this situation often require an angiogram to assess the heart and its arteries. Recent advancements in technology have enabled CTA to clearly define coronary artery anatomy with great accuracy and to guide treatment strategies in select patient populations. We are investigating that CTA may be used, as an alternative to conventional angiograms, for the risk stratification of patients with high risk NSTE-ACS. Patients eligible for the study will be high risk NSTE-ACS and awaiting an angiogram. Enrolled patients will undergo CTA prior to the angiogram. With each CTA the patient will be injected with a small dose of an X-ray dye and will be asked to lie still on the "scanning bed" for a period of 5-10 minutes.
Functional Testing Underlying Coronary Revascularisation
Multivessel Coronary Artery DiseaseVessel Disease4 moreThe objective of this trial is to compare the clinical outcomes and cost-effectiveness of 2 therapeutic strategies, one based on coronary angiography guidance and the other based on coronary angiography with fractional flow reserve (FFR) in multivessel coronary artery disease patients. The trial is a prospective, multicenter, French, randomized clinical trial including men and women ≥ 18 years presenting with significant multivessel disease defined by coronary angiography as coronary narrowing > 50% diameter stenosis in at least 2 major epicardic vessels. The patients who give their informed consent will be randomly assigned to a therapeutic strategy based upon coronary angiography or angiography with FFR testing. In the FFR group, a significant coronary stenosis will be defined by a FFR ≤ 0.8. Based upon this multivessel evaluation (angiography or FFR), the investigator will choose the best therapeutic strategy to his discretion (medical optimal treatment, coronary stenting, coronary artery bypass graft surgery). The aim of revascularization procedures will be to obtain complete revascularization. In the FFR group, only stenosis with FFR≤0.8 will be treated. The primary end point of the trial is a composite of major cardiovascular events including death from any cause, myocardial infarction, any hospitalization for coronary revascularization performed in addition to initial treatment and stroke at 1 year of follow-up. Secondary end points will include adverse events, individual major cardiovascular events, stent thrombosis, bleeding events, occlusion of coronary artery bypass graft, patient's quality of life and cost-effectiveness and 30-day, 6 month, 2-year and 5-year outcomes.
Non-invasive and Invasive Plaque Characterisation
Non ST Elevation Myocardial InfarctionThe accuracy of coronary plaque characterization with Multi-slice computed tomography as compared to intravascular ultrasound and optical coherence tomography will be investigated in patients presenting with acute coronary syndrome without ST-elevation.
ImmeDiate Versus EArLy Invasive Approach in Non-ST-Elevation Myocardial Infarction (IDEAL NSTEMI)...
Non-ST-elevation Myocardial InfarctionOf estimated 140,000 cases of acute myocardial infarction admitted to hospitals in Germany per year, approximately 50% present with Non-ST-elevation myocardial infarction (NSTEMI). The currently available evidence led to current guideline recommendations that a systematic approach of immediate angiography in NSTEMI patients stabilized with contemporary antiplatelet treatment is not mandatory. However, this immediate invasive approach is appealing because it allows treating the underlying cause (the plaque rupture) as early as possible with subsequent reduction of death and recurrent myocardial infarction. In the IDEAL NSTEMI trial we test an immediate invasive approach (<2 h) with an approach 12-72 h according top guidelines with respect to 6 months death and mortality.