
Effect of Hydration Guided by Vigileo on the Prevention of CIN After PCI for Patients With AMI
Myocardial InfarctionContrast-induced NephropathyIn this study, Vigileo is used to guide hydration adjustment, and SCr is used to estimate renal function. The aim of the study is to investigate the preventive effect of adequate hydration guided by Vigileo on contrast induced nephropathy in patients with acute myocardial infarction who undergo PCI.

Femoral Versus Radial Access for Primary PCI
Myocardial InfarctionSTEMIPrimary percutaneous coronary intervention (PPCI) has become the dominant strategy for the treatment of ST-elevation myocardial infarction (STEMI), as studies have shown that PPCI is superior to fibrinolytic therapy. Recent evidence suggests that transradial access (TRA) is superior to transfemoral (TFA) for patients undergoing PPCI. Two large trials report a mortality benefit favouring TRA. The results of these two trials could significantly impact practice guidelines and lead to a recommendation that the approach of choice for primary PCI be radial rather than femoral. This would have significant implications for both PCI centers and interventionalists associated with a large impact on practice and education. Yet, many centers and interventionalists in Canada and in the USA prefer TFA and currently feel pressured in making the change to TRA. With that said, these trials did not include new pharmacotherapy and new technology that would likely have closed or eliminated the gap between TFA and TRA by improving the safety and efficacy of these two approaches. Furthermore, these trials were not powered to conclusively show a mortality benefit. The authors of the two large trials emphasized the need for further trials to confirm the benefits of TRA. The SAFARI-STEMI trial aims to compare TFA with TRA in patients undergoing primary percutaneous intervention (PPCI). The primary outcome will be defined as all cause mortality measured at 30 days. The trial will also evaluate: 1) bleeding events and 2) the composite of death, reinfarction, or stroke defined as major adverse clinical events (MACE). The trial will include the use of antithrombotic therapy with monotherapy, with either bivalirudin or unfractionated heparin; the use of glycoprotein inhibitors IIb/IIIa inhibitors will be avoided. The study will encourage liberal use of vascular closing devices. The trial will also compare delays to reperfusion between the two strategies. Finally, a cost analysis is proposed. In view of recent publications, there is now a need for a large randomized trial using contemporary adjunct therapies to assess the safety and efficacy of the TRA vs. the TFA in PPCI. The proposed trial aims to conclusively show whether there is a survival benefit associated with the TRA approach.

Using AtorVASTatin to Prevent VAscular Inflammatory OccLUSion in the Critically Ill
Myocardial InfarctionStroke1 morePatients are admitted to the critical care unit of the hospital because of medical conditions that have a high likelihood of causing severe problems with blood flow, breathing, or brain function. These conditions also have a high likelihood of causing death. Approximately 10 to 15% of all critically ill patients die in hospital. A large amount of scientific evidence suggests that a substantial proportion of these deaths is due to a combination of blot clotting and inflammation in the blood vessels. Statins are drugs that interfere with cholesterol and fat metabolism. Cholesterol and fat in the blood are associated with blood clotting and inflammation in the blood vessels. Statins are known to be very beneficial in improving the survival after heart attacks, and in preventing heart attacks. The question that VASTVALUS asks is: do statins improve survival among all critically ill patients? In VASTVALUS, we will concentrate on patients that do not currently require a statin because of their medical condition e.g. after a heart attack, but we are concerned with the rest of the critically ill. In VASTVALUS, participating patients will receive either atorvastatin 80 mg daily or a placebo. Atorvastatin is a statin with a well-established record of safety and effectiveness. A placebo has no known medical activity. We will follow all patients in VASTVALUS to determine whether atorvastatin has any effect on the occurrence of death, stroke, heart attack, or kidney failure among the critically ill. Results from VASTVALUS will be shared with the medical community after the study is completed. As with all clinical trials, patients in VASTVALUS participate of their own choice, and can change their mind at any time.

Multicenter Study to Rule Out Myocardial Infarction by Cardiac Computed Tomography
Acute Coronary SyndromeMyocardial Infarction1 moreThe growing availability of cardiac computed tomography (CT)* in emergency departments (EDs) across the U.S. expands the opportunities for its clinical application, but also heightens the need to define its appropriate use in the evaluation of patients with acute chest pain. To address this need, we performed a randomized diagnostic trial (RDT) to determine whether integrating cardiac CT, along with the information it provides on coronary artery disease (CAD) and left ventricular (LV) function, can improve the efficiency of the management of these patients (i.e. shorten length of hospital stay, increase direct discharge rates from the ED, decreasing healthcare costs and improving cost effectiveness while being safe).

Immunoadsorption and Immunoglobulin Substitution for Heart Failure After Myocardial Infarction
Heart FailureCoronary Heart DiseaseThe purpose of this study is to investigate, if immunoadsorption of autoantibodies with subsequent substitution of immunoglobulins is able to improve cardiac function of patients with heart failure after myocardial infarction and presence of cardiac autoantibodies.

Simvastatin Effect on Inflammation and Endothelial Function After Myocardial Infarction
Myocardial InfarctionInflammation1 moreDuring myocardial infarction, inflammatory response may negatively influence ventricle wall remodeling as well as endothelium-dependent vasomotor function in the coronary and systemic arterial systems. Statins have been consistently proved to attenuate inflammation and improve endothelial function. In this study, we tested the effect of different doses of statin on inflammatory response and endothelium-dependent vasodilation.

IK-1001 (Sodium Sulfide (Na2S) for Injection) in Subjects With Acute ST-Segment Elevation Myocardial...
ST-Segment Elevation Myocardial InfractionMyocardial Infarctions (MI) are commonly known as heart attacks. An ST-Segment Elevation Myocardial Infarction (STEMI) is a more severe type of heart attack. Myocardial Infarctions happen when a coronary artery is partially or fully blocked suddenly by a blood clot, causing damage to at least some of the heart muscle being supplied by that artery. In a STEMI, a blood clot completely blocks the coronary artery. This can result in damage to the heart muscle that is supplied by the affected artery. The purpose of the IK-1001 STEMI Study is to evaluate the safety and effectiveness of an investigational study drug (IK-1001). IK-1001 is being studied to determine if it is safe and if it can reduce the amount of damage caused to the heart from a STEMI. Potential subjects may be eligible if they have been diagnosed with a STEMI and undergo a primary percutaneous coronary intervention (PCI, a procedure where a blocked coronary artery is unblocked during a cardiac catheterization), as well as meet other entry criteria. Up to 446 men and women, aged 18-80, will participate in this study at about 50 medical sites around the world. Study participation will last for about six months. Subjects will receive the study drug through an intravenous catheter over three hours during their PCI procedure. Subjects will be monitored in the hospital for approximately three to four days after the PCI. There are three follow-up visits at one, three and six months after the PCI with the study investigator after discharge from the hospital.

Alcohol, Inflammation and Atherosclerosis
ArteriosclerosisMyocardial InfarctionEffect of moderate alcohol consumption in form of red wine, beer and ethanol solution and corresponding de-alcoholised beverages on immune measures. In healthy middle aged men and women In a randomized controlled cross-over trial Two intervention periods over 3 weeks

Cilostazol Stroke Prevention Study : A Placebo-controlled Double-blind Trial for Secondary Prevention...
Cerebral InfarctionThe multi-center, double-blind, placebo-controlled, randomized, group-comparison study was designated to assess the long-term safety and efficacy of the antiplatelet drug cilostazol in preventing the recurrence of cerebral infarction in patients who had suffered a cerebral infarction 1 to 6 months prior to entering the trial.

AngelMed for Early Recognition and Treatment of STEMI
Acute Myocardial Infarction (AMI)Coronary Occlusion1 moreA prospective, randomized multicenter study of subjects with a high-risk of having a myocardial infarction (MI) due to acute coronary syndrome or bypass surgery. There is no differential intervention administered to the two arms of the ALERTS Study. The study evaluates whether or not a patient alarm from the Guardian System will provide benefit (e.g. shorten pre-hospital delay) compared to symptoms-only ER presentation in the event of a heart attack. An amendment to the data analysis protocol was collaboratively created by AngelMed and FDA, and was adopted by AngelMed on 4/22/2017.