A Study of NP-011 in Healthy Volunteers
Myocardial InfarctionThis is a Phase 1, randomised, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study to evaluate the safety, tolerability, and pharmacokinetic of NP-011 in healthy volunteers.
Evaluation of eCPR Survivors
Cardiac ArrestCardiopulmonary Resuscitation3 moreA cardiac arrest event has severe impact on the patient´s health-related quality of life. Survival of cardiac arrest does not innately translate to favorable quality of life. In particular, highly invasive resuscitation strategies, including extracorporeal cardio-pulmonary resuscitation (ECPR) due to therapy-refractory cardiac arrest, may have impact on long-term outcomes. Therefore, apart from acute medical treatment and physical rehabilitation, long-term effects on cardio-pulmonary, physical and neuro-psychiatric functions after cardiac arrest survival have to be evaluated and optimized. We plan to investigate a bundle of cardio-pulmonary, physical and neuro-psychiatric functions in patients who survived a therapy-refratory cardiac arrest with ECPR.
Sonothrombolysis in Patients With STEMI
ST-segment Elevation Myocardial InfarctionThis study evaluates what effect sonothrombolysis may have on spontaneous reperfusion, microvascular obstruction, left ventricular function and infarct size in patients presenting with their first ST-segment Elevation Myocardial Infarction.
COlchicine for Left VEntricular Remodeling Treatment in Acute Myocardial Infarction
Myocardial InfarctionInflammatory processes have been identified as key mediators of ischemia/ reperfusion injury in ST-segment elevation myocardial infarction. They add additional damage to the myocardium and are associated with clinical adverse events (heart failure and cardiovascular death) and poor myocardial recovery. All the different anti-inflammatory approaches to reduce reperfusion injury have been disappointing. Colchicine is a well-known substance with potent anti-inflammatory properties. In a recent pilot study performed in 151 acute STEMI patients treated with primary percutaneous coronary intervention(PPCI) Deftereos et al. showed a 50% reduction of infarct size (creatine kinase release) with a short course treatment of colchicine in comparison to placebo. One mechanism to explain this effect could be the reduction of adverse left ventricular (LV) remodelling. LV remodelling is part of the healing process of myocardium after MI. It is defined as the end diastolic volume (EDV) increase in the first months after MI. Adverse LV remodelling is increased by inflammation and ultimately leads to heart failure. Our main hypothesis is that colchicine with its anti-inflammatory properties significantly reduces the initiation of adverse LV remodelling, together with a significant reduction of infarct size and microvascular obstruction in comparison to placebo in acute STEMI patients referred for PPCI. After inclusion and randomisation, patients will receive the first part of their experimental treatment: colchicine or placebo before PCI, then, the second part after PCI and during 5 days. They will be followed up during their hospitalization and until one year. In order to evaluate LV remodelling, two cardiac magnetic resonance studies will be performed during their participation: one during their hospitalization and a second at 3 months. At 1 year, adverse events will be collected by phone.
Paroxetine-mediated GRK2 Inhibition to Reduce Cardiac Remodeling After Acute Myocardial Infarction...
Cardiac RemodelingMyocardial InfarctionThis study evaluates the off-target effect of paroxetine to reverse cardiac remodeling and improve left ventricular ejection fraction in patients after acute myocardial infarction. Half of the participants will receive paroxetine, while the other half will receive placebo treatment.
Platelet Inhibition With Cangrelor and Crushed Ticagrelor in STEMI
ST Segment Elevation Myocardial InfarctionPercutaneous Coronary InterventionIn STEMI patients undergoing PPCI there is a delayed onset of action of oral P2Y12 receptor inhibitors, including prasugrel and ticagrelor. Crushing prasugrel and ticagrelor improves their PK and PD profiles as it favors drug absorption and onset of antiplatelet effects and because of this, it is commonly used in STEMI patients undergoing PPCI. However, despite the use of crushed tablets, up to one-third of patients may still have high on-treatment platelet reactivity (HPR) within the first 2 hours after loading dose (LD) administration of these oral agents. Cangrelor is a potent intravenous P2Y12 receptor inhibitor with rapid onset and offset of action associated with a greater reduction in ischemic events compared with clopidogrel in P2Y12 receptor naïve patients undergoing PCI. To date most studies have explored cangrelor in the setting of PCI subjects treated with clopidogrel. The PD effects of cangrelor in STEMI patients undergoing PPCI treated with a newer generation P2Y12 receptor inhibitor and how this compares with a crushed formulation of the oral drug is unexplored. The aim of this prospective randomized study is to investigate the PD effects of cangrelor in STEMI patients undergoing PPCI treated with crushed ticagrelor.
Apixaban Versus Warfarin in Patients With Left Ventricular (LV) Thrombus
Acute Myocardial InfarctionLeft Ventricular Thrombosis1 morePatients with acute ST-segment elevation myocardial infarction (STEMI) have an elevated risk of stroke, most of which are cardio-embolic in origin as a result of left ventricular (LV) thrombus formation. Anterior-wall location of a MI, in particular, can lead to the complications of LV aneurysm and/or thrombus, which some estimate occurs in approximately up to one-third of individuals within the first 2 weeks following an anterior MI. In the absence of anti coagulation, the risk of embolization in patients with a documented LV thrombus has been reported to be between 10 and 15 percent [3]. Although there are no randomized trials evaluating the efficacy of anticoagulation in patients with an LV thrombus after MI, observational studies provide substantial supporting evidence for the recommendation to anticoagulate patients with documented LV thrombus in order to reduce the risk of embolization. The observation that most events occur within the first three months from the MI forms the basis for the recommendation that anticoagulant therapy should be started early and continued for at least three to six months after myocardial infarction. Currently the practice guidelines recommend anticoagulation after MI only in certain settings such as the presence of LV thrombus or atrial fibrillation. To date there are no data on the use of novel oral anticoagulants (NOACS) for stroke prevention in the setting of LV thrombus after acute MI. The proposed aim of this randomized open label non inferiority clinical trial is to assess whether apixaban is as effective as VKA for the treatment of LV thrombus after acute ST segment elevation MI. Population: Patients with evidence of LV thrombus as assessed by trans-thoracic echocardiography (TTE) 3 to 7 days post admission for acute ST-elevation MI Intervention: The patients will be randomly assigned to treatment with apixaban or s.c enoxaparin 1mg/Kg BID followed by dose-adjusted warfarin to achieve a target international normalized ratio (INR) of 2.0 to 3.0 for 3 months. The study Outcomes are the presence of LV thrombus as assessed be echo, major bleeding, and stroke or systemic embolism and death from any cause.
Management of Anger in Patients With Acute Myocardial Infarction (MAPAMI)
Myocardial InfarctionStress, anger and depressed can operate as a trigger to an Acute Coronary Syndrome. It is often found in the literature that patients refer excessive anger, anxiety, sadness, pain or acute stress before the acute myocardial infarction (AMI). Moreover, a recent meta-analysis reported a strong association between the occurrence of AMI and many of these acute emotions. Anger is a common manifestation of psychological stress and could trigger off an atherogenic process through several mechanisms. Coronary atherosclerosis features narrowing of coronary arteries on account of endothelial thickening caused by the build up of atheromatous plaques. It is a process characterized by inflammatory and fibroproliferative response of the artery wall, caused by continuous aggression to its surface and whose thickening, evoked by the evolution of fat streaks atherosclerotic lesions, until fiber plaques is quite slow. Endothelial dysfunction also results in the loss of natural anti-thrombotic properties involved in the endothelium patency. According to a study performed by our group, anger management was significantly lower among patients with CAD when compared to those without CAD, and the occurrence of major cardiovascular events (MACE) was significantly higher in patients presented with lower anger control. Both associations were independent from traditional risk factors, occurrence of previous events or another anger aspects. Thus, this study was designed in order to evaluate the effect of the "cognitive training to anger management " on endothelium-dependent vasodilation of the arm artery in patients with acute myocardial infarction with ST segment elevation submitted to primary coronary intervention.
Prospective ARNI vs ACE Inhibitor Trial to DetermIne Superiority in Reducing Heart Failure Events...
Acute Myocardial InfarctionThe purpose of this study is to evaluate the efficacy and safety of LCZ696 titrated to a target dose of 200 mg twice daily, compared to ramipril titrated to a target dose of 5 mg twice daily.
Tailored Use of Tirofiban for Non-ST-elevation Acute Coronary Syndrome Patients
Non-ST Elevation Myocardial InfarctionInvestigators aimed to test the beneficial effect of tirofiban, a GPIIb/IIIa antagonist, for Non-ST-Elevation Acute Coronary Syndrome Patients who has high resistance to clopidogrel.