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107 active trials for Acute Myocardial Infarction

Efficacy and Safety of Adjunctive Cilostazol in Acute Myocardial Infarction Patients

Current antiplatelet therapy in acute coronary syndrome have a focus on the dual antiplatelet therapy including aspirin and clopidogrel. However, the patient's drug resistance of aspirin and clopidogrel is the important cause of poor clinical prognosis. Therefore, recently, clinical research about the triple antiplatelet therapy including cilostazol is actively conducted. But, clinical research about triple antiplatelet therapy for acute myocardial infarction is inadequate situation, and the ideal duration of triple antiplatelet therapy has been actively discussed. Therefore, we try to evaluate the clinical outcomes of triple antiplatelet therapy in acute myocardial infarction patients undergoing percutaneous intervention with drug eluting stent compared with dual antiplatelet therapy and investigate ideal duration of triple antiplatelet therapy through this research.

Start: July 2011

Optimized Antithrombotic Therapy of Acute Myocardial Infarction With Left Ventricular Mural Thrombus

A multi-center study will be done to explore the optimal regimen of antithrombotic therapy for acute myocardial infarction with left ventricular mural thrombus. The investigators will evaluate the different combinations of antiplatelet drugs and anticoagulants for at least one month, such as aspirin 100mg qd+clopidogrel 75mg qd+warfarin (INR1.8-2.2), aspirin 100mg qd+clopidogrel 75mg qd+dabigatran 110mg bid, aspirin 100mg qd+ticagrelor 60mg bid+warfarin (INR1.8-2.2), and aspirin 100mg qd+ticagrelor 60mg bid+dabigatran 110mg bid. Transthoracic two-dimensional echocardiography will be done at the 1-month, 3-month and 6-month follow-ups to evaluate the left ventricular mural thrombus and determinate whether the antithrombotic therapy regimen could be regulated to double antiplatelet or anticoagulant+clopidogrel 75mg qd/ticagrelor 60mg bid. Then the investigators will complete the 12-month follow-up to evaluate the efficacy and safety of the optimal antithrombotic therapy regimen for acute myocardial infarction with left ventricular mural thrombus.

Start: June 2020

MitraClip in Acute Mitral Regurgitation

Acute MR may develop in the setting of an acute myocardial infarction (AMI) as a result of papillary muscle dysfunction or rupture, and these patients are grossly underrepresented in MitraClip registries. Our group has recently published the Spanish experience with MitraClip in acute MI, but only 5 patients could be collected. However, the results of our initial experience are highly encouraging since patients performed well in such life-threatening condition. In order to expand the information of the device in this condition, our aim is to start a multinational registry in Europe.

Start: January 2017

TURKish Acute Myocardial Infarction Registry

There is no up-to-date information regarding presentation, management and clinical course of patients with acute myocardial infarction (MI) in Turkey. TURKMI registry is designed to provide insight to the characteristics, management from symptom onset to the hospital discharge and outcome of patients with acute MI in Turkey.

Start: November 2018

Danish Trial of Beta Blocker Treatment After Myocardial Infarction Without Reduced Ejection Fraction

To determine whether long-term treatment with oral betablocker (BB) therapy after myocardial infarction (MI) in patient with no heart failure reduces the composite outcome of death from any cause, recurrent MI, unstable angina pectoris, stroke or heart failure.

Start: December 2018

Systemic, Pancoronary and Local Coronary Vulnerability

• The aim of the VIP study is to investigate the impact of vulnerability markers (inflammatory serum biomarkers for systemic vulnerability, coronary shear stress and vulnerability mapping for pancoronary vulnerability, and imaging-based plaque features for systemic vulnerability) on the rate of major adverse cardiovascular events caused by progression of the non-culprit lesion in patients with acute ST or non-ST segment elevation myocardial infarction who undergo revascularization of the culprit lesion during the acute event. Furthermore, the study will evaluate the rate of progression of non-culprit lesions towards a higher degree of vulnerability, based on coronary computed tomography angiographic assessment at 1 year after enrollment.

Start: October 2018

Efficacy and Safety of Direct Oral Anticoagulants for the Treatment of Mural Thrombus

To describe the prescribing patterns at MDMC for the treatment of newly diagnosed mural thrombus and to determine the efficacy and safety of DOACs apixaban, dabigatran, and rivaroxaban in comparison to warfarin. With limited treatment guideline consensus, minimal evidence to support the use of DOACs for LAA thrombus and LVT, and a lack of evidence for the use of DOACs in aortic thrombus, further research is warranted to determine the role of DOACs in the treatment of various mural thrombi in comparison to warfarin.

Start: November 2019

Safety and Efficacy Study of Gene Therapy for Acute Myocardial Infarction in Korea

The purpose of this study is to evaluate the safety and clinical efficacy of VM202RY injected via transendocardial route using C-Cathez® catheter (Celyad, S.A., Belgium) in subjects with AMI. Stage 1: Evaluation of safety and tolerability of VM202RY injection Stage 2: Evaluation of safety and efficacy of VM202RY injection

Start: January 2018

Glycoprotein IIb/IIIa Inhibitors Versus Standard Therapy in Patients With Myocardial Infarction and No-reflow

Aim of the study is to examine the effects of glycoprotein IIb/IIIa inhibitors on reperfusion success assessed by cardiac magnetic resonance imaging in patients with myocardial infarction and angiographic evidence of no-reflow.

Start: July 2016

Psyhosomatic Medicine in Oncologic and Cardiac Disease Study

Psychological processes play a complex role in the pathophysiology of many diseases. However, the body and emotional perception of patients and the relationship between dreams and disease still need to be investigated. The investigators planned an observational and controlled research aimed at assessing some previously unaddressed baseline psychological characteristics and their changes at 1 and 5 years after a short-term psychotherapy in carefully characterised patients with heart or oncologic diseases . The patients that will be enrolled are: 50 patients ? 75 year old with acute myocardial infarction; 30 patients ? 75 year old with Tako-Tsubo syndrome; 50 women ? 75 year old, recently operated on breast cancer: 90 control subjects of the same age and gender of the enrolled patients, without relevant pathologies during the last 10 years. Relevant pathologies are defined as those that required a hospitalisation or a long-lasting medical therapy. At the enrolment all the subjects will undergo a complete medical evaluation, and the following psychometric tests: Self-evaluation test, Social Support Questionnaire, Beck Depression Inventory II (BDI II), MacNew Heart Disease Health-Related Quality of Life Questionnaire, State-Trait Anxiety Inventory (STAI), State-Trait Anger Expression Inventory (STAXI 2). In two distinct following meetings, an open questionnaire exploring the body and emotional perception, and another exploring past and recent dreams, will be administered. The same evaluation will be done for the healthy subjects. After the initial evaluation, all the patients will be given the choice to start a short-term psychotherapy lasting 6 months on top of medical therapy or to continue classic medical therapy only. Healthy subjects will be not offered the possibility to follow psychotherapy. At first year of follow-up, the battery of psychometric test, and the two questionnaires exploring the body and emotional perception, and changes and characteristics of dreams during the psychotherapy, will be re-administered. The following data will be evaluated: Psychological characteristics at follow-up. Incidence of new relevant medical events Quality of life Relationship between psychological characteristics and health status, and quality of life At 5 year follow-up psychometric tests and the clinical data will be evaluated in all the groups.

Start: March 2018

FLOW Evaluation to Guide Revascularization in Multi-vessel ST-elevation Myocardial Infarction

Although current guidelines recommend fractional flow reserve (FFR) to identify haemodynamically relevant coronary lesion(s) in stable patients when evidence of ischaemia is not available (Class I, Level of Evidence: A), no published study has assessed the usefulness of FFR to guide percutaneous coronary intervention (PCI) in ST-elevation myocardial infarction (STEMI) patients with multi-vessel disease (MVD). The main objective of this study is to determine whether, in STEMI patients with MVD amenable to PCI, the use of FFR in addition to angiography will improve cardiovascular outcomes, compared with the current practice of angiography- guided PCI, by improving the appropriateness of revascularisations by assessing the relevance of non-culprit lesions in the context of STEMI with multivessel coronary artery disease. The secondary objective is to assess the safety and the cost-effectiveness of the FFR-guided strategy compared to the angiography-guided strategy.

Start: December 2016

Drug-coated Balloon Versus Drug-eluting Stent in the Treatment of Coronary Artery Lesions in STEMI Patients in De Novo Coronary Lesions

The study aims to find a DCB treatment for STEMI patients can achieve early and mid-term functional outcomes that are not inferior to DES, and realize the strategy of intervention without implantation.

Start: September 2019

Sleep Disordered Breathing (SDB) Prevalence and Cardiovascular Outcomes of Myocardial Infarction (MI) Survivors

The AMISLEEP study is nested in the "FRENCHIE" registry. The objective is to use routine clinical and polygraphic data to capture SDB/SAS (Sleep Disordered Breathing/Sleep Apnea Syndrome) physiological heterogeneity in relation to clinically relevant cardiovascular outcomes. Specifically, the investigators hypothesize that unique clusters (phenotypes) of patients could be identified by applying unsupervised learning methods to these data and that the clusters would be differentially associated with risk of adverse cardiovascular outcomes (ACS), TIA, stroke or death). The ultimate goal is to identify patients more at risk that could be included in interventional studies that would test whether SDB/SAS treatment can improve this risk.

Start: April 2019

French Cohort of Myocardial Infarction Evaluation

Over the last two decades, considerable progress has been made in the management of Acute Myocardial Infarction (AMI), both in the acute phase and in monitoring beyond the hospital phase. Nevertheless, the evolution of care practices and their impact on the mid- and long-term prognosis of patients admitted to the intensive care unit for acute myocardial infarction remain relatively little studied exhaustively. The aim of this study is to assess the profile of AMI patients, their management and follow-up in order to evaluate the relationship between these factors and outcomes.

Start: March 2019

Apixaban Versus Warfarin in Patients With Left Ventricular (LV) Thrombus

Patients 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.

Start: January 2018

Impact of Treating Severe Periodontitis on Inflammatory Activity of Atheromatous Plaques in Patients With Acute Myocardial Infarction (AMI)

Multicenter randomized clinical trial with two arms in patients hospitalized for an AMI nested in the Frenchie registry. Periodontal therapy is performed by periodontists in the intervention group versus treatment by dental surgeons as part of their usual practice in the control group. For the intervention group, periodontal management will be carried out for a maximum of 6 months after randomisation, prolonged by a follow-up of 6 months including a maintenance visit at M9. All patients will have an FDG-PET at M0 and M12 for evaluation of inflammation on carotid atherosclerotic plaques.

Start: August 2019

China Tongxinluo Study for Myocardial Protection in Patients With Acute Myocardial Infarction

To determine the therapeutic effects of Tongxinluo Capsules as compared with placebo in the treatment of patients with acute ST-elevation myocardial infarction (STEMI): (1) Clinical efficacy and safety at 30 days: the incidence of composite endpoints comprising major adverse cardiovascular and cerebrovascular events (MACCE, including cardiovascular death, myocardial re-infarction, emergency coronary revascularization and cerebral stroke), severe complications (including cardiogenic shock, heart failure, mechanical complications and malignant arrhythmias), and major bleeding (BARC grade III and V); (2) Clinical efficacy and safety at 1 year: the incidence of composite endpoints comprising MACCE, hospitalization due to heart failure, in-stent thrombosis, and major bleeding (BARC grade III and V), as well as all-cause mortality; (3) the effects in promoting myocardial reperfusion, reducing incidence of myocardial no-reflow, protecting ischemic myocardium, minimizing infarction size, and improving left ventricular systolic function.

Start: May 2019

Periodontal Disease, Inflammation and Acute Coronary Syndromes

Recent studies have shown that the systemic inflammation caused by periodontal disease (PD) can determine important changes in the coronary arteries, favoring atherosclerosis progression and development of acute coronary syndromes (ACS). The aim of ATHERODENT study is to assess the interrelation between PD, inflammation and progression of coronary atherosclerosis in patients with ACS. Material and methods: This case-control observational study will enroll 100 patients (group 1 - ACS and associated PD, and group 2 -ACS and no PD), in whom the following data will be collected: (1) demographic and clinical data, (2) cardiovascular risk factors, (3) full characterization of PD markers, (4) systemic inflammatory biomarkers, (5) imaging biomarkers derived from transthoracic echocardiography, computed tomography, coronary angiography, optical coherence tomography and intravascular ultrasound, and (6) assessment of the presence of specific oral bacteria in samples of coronary plaques collected by coronary atherectomy, which will be performed during percutaneous revascularization interventions, when indicated in selected cases, in the atherectomy sub-study. The follow-up will be performed at 1, 3, 6, 12, 15, 18 and 24 months. The primary endpoint of the study will be represented by the rate of major adverse cardiovascular events (MACE rates) in PD vs non-PD patients and in correlation with: (1) the level of systemic inflammation triggered by PD and/or by ACS at baseline; (2) the vulnerability degree of atheromatous plaques in the coronary tree (culprit and non-culprit lesions); and (3) the presence and burden of oral bacteria in atheromatous plaques. Secondary endpoints will be represented by: (1) the rate of progression of vulnerability degree of non-culprit coronary plaques; (2) the rate of progression of atheromatous burden and calcium scoring of the coronary tree; and (3) the rate of occurrence of left ventricular remodeling and postinfarction heart failure.

Start: May 2018

Inflammation-mediated Coronary Plaque Vulnerability, Myocardial Viability and Ventricular Remodeling

VIABILITY study aims to investigate the link between systemic inflammation, pancoronary plaque vulnerability (referring to the plaque vulnerability within the entire coronary tree), myocardial viability and ventricular remodeling in patients who had suffered a recent ST-segment elevation acute myocardial infarction (STEMI). The level of systemic inflammation in the acute phase of the myocardial infarction and at 1 month will be assessed on the basis of serum levels of inflammatory biomarkers (hsCRP, matrix metalloproteinases, interleukin-6). Pancoronary plaque vulnerability will be assessed: (1) in the acute phase of the infarction, based on serum biomarkers known to be associated with increased plaque vulnerability, such as adhesion molecules (V-CAM or I-CAM) determined from the blood samples collected in the first day after STEMI; (2) at 1 month after infarction, based on computed tomographic angiography analysis of vulnerability features present in all coronary plaques. Myocardial viability and remodeling will be assessed based on: (1) 3D speckle tracking echocardiography associated with dobutamine infusion; (2) MRI imaging associated with complex post-processing techniques for mapping myocardial fibrosis and scar at the level of left atrium and left ventricle. At the same time, CT imaging features associated with systemic and local inflammation, such as global epicardial fat or local pericoronary epicardial fat will be quantified in order to investigate the impact of inflammatory-mediated plaque vulnerability on the extent of myocardial damage in acute myocardial infarction. All these parameters will be investigated in patients with successful primary revascularization performed in a timely manner for ST-segment elevation acute myocardial infarction, who will be divided into 2 groups: group 1 - patients who present persistence of an augmented inflammatory status defined as serum levels of hsCRP>3.0 mg/dl at discharge from the hospital or at 7 days postinfarction (whichever comes first), and group 2 - patients with no persistence of augmented inflammatory status (hsCRP<3.0 mg/dl). The primary endpoint of the study will be represented by the rate of post-infarction heart failure development, defined as the rate of re-admission in the hospital for heart failure or by a significant decrease in the ejection fraction (<45%). The secondary endpoints of the study will be: rate of re-hospitalization rate of repeated revascularization rate of major adverse cardiovascular events (MACE rate, including cardiovascular death or stroke)

Start: July 2019

Comprehensive Oral Intervention in Patients With AMI

The investigators performed a randomized controlled trial with investigator-masked design enrolling subjects with acute myocardial infarction. The purpose of this study is to find a treatment strategy to reduce the risk of recurrence of myocardial infarction through oral hygiene improvement.

Start: July 2019