Myocardial Infarction

This study was designed to investigate the effects of VR (virtual reality) glasses on vital signs and anxiety in conscious patients diagnosed with myocardial infarction and admitted to the cardiology intensive care unit.

This study is open to adults with ST elevation myocardial infarction (heart attack) undergoing primary percutaneous coronary intervention (PCI). The purpose of this study is to determine whether a medicine called Xolatryp is safe and effective in improving cardiac outcomes. One dose of Xolatryp will be tested in this study. Participants are put into two groups randomly, which means by chance. One group receives a single 6-hour continuous intravenous infusion of Xolatryp and one group receives placebo. Participants are in the study for about 30 days. Placebo infusion looks like Xolatryp but do not contain any medicine. Participants are followed up via telephone and there is one visit to the study site on day 30. Heart health is assessed based on the analysis of blood samples, which are collected at the study site, via electrocardiogram (ECG), echocardiogram and cardiac magnetic resonance (CMR) imaging. At the end of the study, the results are compared between the two groups. During the study, the doctors also regularly check the general health of the participants.

Multicenter Prospective Controlled Randomized Trial, open-label, in patients with atherosclerotic cardiovascular disease (ASCVD) (acute coronary syndrome or chronic coronary syndrome and ischemic heart failure) and an approved indication for cardiac rehabilitation (CR). Patients completing phase II CR will be randomized 1:1 to usual Phase-III care (standard care) versus standard care plus the Digitally-Enhanced Extended PrEvention \& Rehabilitation (DEEPER) package (intervention). Primary outcome is 6-month change in composite Life's Crucial 9 (LC9) (LE8 + PHQ-9).

The primary aim of this study is to evaluate the efficacy and safety of novel P-CAB (tegoprazan 50 mg once daily) as compared with standard PPI (rabeprazole 20 mg once daily) for protection of GI events in patients with known cardiac and vascular disease receiving chronic use of antithrombotic drugs (either antiplatelets, OAC, and its combinations) who are at high GI bleeding risk. The primary hypothesis is that P-CAB (experimental arm) would non-inferior to PPI (standard arm) with respect to the rate of the primary composite end point of GI events at 12 months after randomization.

POLARIS is a prospective, single-centre, single-arm observational pilot registry evaluating the real-world safety and efficacy of the Focus np (Abluminus np, Concept Medical, Tampa, FL, USA) polymer-free sirolimus-eluting stent in consecutive adult patients undergoing percutaneous coronary intervention (PCI). The primary endpoint is target lesion failure (TLF) at 12 months, defined per Academic Research Consortium-2 (ARC-2) criteria as the device-oriented composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularisation. Patients treated since January 2021 will be retrospectively identified and prospectively consented, with follow-up through 5 years. The registry will provide the first Western clinical evidence on this CE-marked device and serve as a template for a future national Swiss multicentre registry.

Cardiac troponin is a protein released into the blood when the heart muscle is damaged. Measuring this protein helps doctors diagnose a heart attack (also called a myocardial infarction). Modern blood tests, known as high-sensitivity cardiac troponin assays, can detect very small amounts of this protein. A new version of this test, called Troponin T high-sensitivity Gen 6, has recently been developed and approved for use. It is designed to be more accurate and reliable, detecting smaller changes in troponin levels and being less affected by technical interference. The investigators believe this improved test will allow doctors to diagnose heart attacks more quickly and decide sooner who needs to stay in hospital and who can safely go home. This could help reduce overcrowding in Accident and Emergency (A\&E) departments, a major challenge for the NHS. This study will examine whether switching to this new test across a health board shortens the time patients with suspected heart attacks spend in the Emergency Department. The investigators will use information from the DataLoch Heart Disease Registry, which automatically collects anonymised hospital data for patients attending with possible heart attacks. The investigators will compare data from one year before and one year after implementation to see whether average length of stay changes and to confirm that patient safety remains high. This investigators will also measure both the current and new versions of the troponin test in surplus blood samples collected during two six-month periods-one before and one after the new test is introduced. This will allows the investigators to directly compare the two tests reliably. Patients will not need to do anything extra to take part - the study uses information and samples already collected as part of their usual care.

Cardiac rehabilitation (CR) is an effective evidence-based intervention that improves outcomes in patients with acute coronary syndrome (ACS), but many eligible patients do not complete the program. A hybrid CR intervention that combines telehealth, home-based, and clinic-based components (TeleheartCR) may increase participation by addressing barriers to access while maintaining the functional capacity benefits of traditional CR. The purpose of this study is to conduct a randomized controlled trial comparing TeleheartCR with traditional clinic-based CR in patients with ACS to evaluate differences in program adherence and pre-to-post program change in functional capacity.

This prospective, multicenter, cluster-randomized controlled study aims to evaluate the accuracy of an investigational artificial intelligence (AI) Software as a Medical Device (SaMD) designed to compute ejection fraction (EF) severity categories based on the American Society of Echocardiography's (ASE) 4-category scale. The software analyzes continuous ECG waveform data acquired by the FDA-cleared Peerbridge COR® ECG Wearable Monitor, an ambulatory patch device designed for use during daily activities. The AI software assists clinicians in cardiac evaluations by estimating EF severity, which reflects how well the heart pumps blood. In this study, EF severity determination will be made using 5-minute ECG recordings collected during a 15-minute resting period with participants seated upright. The results will be compared to EF severity obtained from an FDA-cleared, non-contrast transthoracic echocardiogram (TTE) predicate device. This comparison aims to validate the accuracy of the AI software.

This study investigates a new way to diagnose severe heart attacks in patients who have a specific electrical heart pattern called a Left Bundle Branch Block (LBBB). When patients present to the emergency department with chest pain, doctors routinely perform an electrocardiogram (ECG) to check for a heart attack. However, the presence of an LBBB can alter the heart's electrical signals on the ECG, effectively masking or hiding the typical signs of an ongoing acute coronary occlusion (a completely blocked artery). This making it highly challenging for emergency physicians to make an accurate and rapid diagnosis. The primary purpose of this prospective and observational research is to develop and evaluate an artificial intelligence/machine learning (ML) model that can analyze digital 12-lead ECG signals to accurately predict a true blocked coronary artery in patients with LBBB. The machine learning model will analyze raw digital ECG waveforms to detect subtle, microscopic patterns that might be missed by the human eye. To confirm the accuracy of the model, its predictions will be compared directly with invasive coronary angiography results, which is the gold standard reference method used to visualize blocked vessels. Additionally, the study aims to evaluate if the model can differentiate between a true heart attack caused by a blocked artery (Type 1 MI) and other non-occlusive conditions that cause elevated heart enzymes (Type 2 MI). Ultimately, the investigators intend to determine whether integrating this machine learning tool into emergency care can safely reduce the rate of unnecessary emergency invasive procedures for patients who do not have a true coronary blockage.

Patients hospitalized for acute cardiac conditions-including acute myocardial infarction, acute heart failure, pulmonary embolism, arrhythmias, and hypertensive emergencies-represent a heterogeneous population at very high risk of recurrent cardiovascular events. Influenza infection may act as a trigger for adverse cardiovascular events. Given the persistently low influenza vaccination uptake despite evidence-based benefits observed in vulnerable populations, including patients with cardiac conditions, new strategies to improve vaccination coverage are being explored. Recently, increasing attention has been directed toward an approach already used in fields such as neonatology, where vaccinations are administered prior to hospital discharge. In this investigator-initiated, single-center, randomized, open-label interventional study, we will evaluate whether influenza vaccination administered within 24 hours before hospital discharge in patients hospitalized for acute cardiac conditions is safe and effective in reducing subsequent infections, cardiovascular events, and mortality during the 6 months following hospitalization.

ST-segment elevation myocardial infarction (STEMI) is an acute condition that accounts for 75% of sudden deaths in adults over 35 years of age and more than half of all cases of chronic heart failure. However, the mechanism of myocardial infarction remains poorly understood. At present, there is no national information system for myocardial infarction, as there is for other diseases such as multiple sclerosis (OFSEP cohort). The purpose of this cohort is to enable studies and research projects to be carried out on the descriptive epidemiology of myocardial infarction, monitoring of patients undergoing treatment (safety, efficacy), quality of life and functional consequences of infarction, and research into new biological and imaging prognostic biomarkers. Its general objective is to provide researchers, hospital practitioners, medical interns, academics or industrialists with a quality epidemiological tool for research.

To compare clinical outcomes of myocardial infarction with non-obstructive coronary arteries (MINOCA) according to the coronary microvascular dysfunction (CMD), evaluated by optical coherence tomography (OCT), invasive and non-invasive coronary physiologic assessment.

Evaluation of clinical outcomes during 12 months after inclisiran initiation in patients after STEMI/non-STEMI in real-world settings in Russia. It is also planned to study the therapy effect on the lipid profile characteristics, its safety, the state of atherosclerotic plaques according to carotid ultrasound, the frequency of hospitalizations and the need for intensive follow-up.

Cardiac events can often result in debilitating and persistent psychological symptoms. A key question involves whether optimal treatment of cardiac-induced posttraumatic stress disorder (PTSD) reduces PTSD symptoms and thereby may offset the risk of recurrent or worsening cardiovascular disease. Cardiac-induced PTSD 1) is prevalent, 2) features symptoms unique to internal ongoing somatic threat, with fears and worries that can be distinguished from PTSD resulting from external causes, 3) is persistent, 4) is associated with negative physical and emotional consequences, and 5) has not been the subject of randomized-controlled treatment trials (RCT). There is preliminary evidence suggesting that patients with cardiac-disease induced PTSD might particularly profit from EMDR. Nevertheless, this possibility has not been tested in cardiac-induced PTSD. Currently, patients with cardiac-induced PTSD are not routinely offered trauma-focused therapies, with a lack of scientific evidence likely being one major reason for this omission. If our proposed RCT shows that EMDR can be an effective treatment for patients with ACS-induced PTSD, EMDR could be routinely implemented as first-line treatment. The RCT outcomes might inform larger trials to test whether poor prognosis in terms of major adverse cardiovascular events can be improved through EMDR in patients with cardiac-induced PTSD.

The aim of the study is to compare clinical outcomes between optical coherence tomography-guided versus angiography-guided percutaneous coronary intervention (PCI) in patients with acute myocardial infarction (AMI).

The primary purpose of this study is to determine if there are significant differences with respect to baseline between those randomized to CGo and standard-of-care versus standard-of-care alone after completing 12-weeks of therapy in terms of peripheral endothelial function measured by EndoPAT.

The main aim of the study is to build and test a cardiac-specific coil purposely assembled in house to suit the FFC-MRI whole-body prototype and to test if it could be used for clinical cardiac scans in human subject populations.

A total of 220 patients (110 per arm) who report moderate alcohol consumption between 1 and 28 standard units (1 standard unit = \~10 grams) per week in the 12 months prior to hospital admission will be planned for randomization, using a 1:1 ratio to pursue moderate alcohol consumption (1 standard unit per day for women and 2 standard units per day for men) or abstinence (except for one drink on predefined/agreed special occasions) for a total duration of 3 months. An echocardiography will be performed at baseline and 3 months to assess changes in systolic cardiac function (LVEF) for the primary endpoint. A core laboratory team blinded to assignment will perform data interpretation.

The goal of this clinical trial is to learn if preoperative intranasal dexmedetomidine works to reduce perioperative myocardial injury and myocardial infarction in patients undergoing elective percutaneous coronary intervention (PCI). It will also learn about the safety of intranasal dexmedetomidine. The main questions it aims to answer are: Does preoperative intranasal dexmedetomidine lower the incidence of perioperative myocardial injury and myocardial infarction after PCI? Does intranasal dexmedetomidine cause safety concerns in patients undergoing PCI? Researchers will compare intranasal dexmedetomidine to a placebo (a look-alike substance that contains no drug) to see if intranasal dexmedetomidine works to protect the heart during PCI. Participants will: Receive either intranasal dexmedetomidine (100 μg) or a placebo (normal saline) 15 minutes before the PCI procedure Undergo blood tests to measure cardiac troponin levels before and after the procedure Be followed for up to 30 days after the procedure to record any heart-related events or side effects

This prospective observational cohort study, will investigate the platelet phenotype, platelet genetic composition, and role of platelets as effector cells in women and men with myocardial infarction (MINOCA or MI-CAD) and controls. This study, which will take place at NYU and Bellevue Medical Center, and participating external sites. May have concurrent enrollment with the HARP Main Imaging (NCT02914483). Additionally, a sex, group of age and race matched disease controls 'CATH-NOCA' composed of women and men with stable angina referred for cardiac catheterization, will be enrolled. Blood obtained during the initial catheterization and 2 months post-MI will be utilized for platelet testing.

The goal of this interventional study is to determine the minimum dose necessary for successful cardiac radioablation of refractory ventricular tachycardia (VT) and to study the utility of target volume definition using Delayed Enhancement Cardiac MRI (DE-CMR) .

AliveCor (www.alivecor.com) has developed several electrocardiogram (ECG) devices that interface with iOS and Android smartphones and tablets via various Kardia apps. The current Kardia family of devices can measure single lead and six limb-lead ECGs, depending on the device. KardiaMobile, KardiaMobile 6L, and KardiaMobile Card have FDA clearance for ECG rhythm recording. A modified single-lead Kardia smartphone 12-lead ECG was previously validated in the multicenter ST LEUIS study for the diagnosis of ST-Segment Elevation Myocardial Infarction (STEMI) and Non-ST-Elevation Myocardial Infarction (NSTEMI). Recently, AliveCor developed a new device: AliveCor (AC) 12-lead (12L) ECG System to record simultaneously 4 leads of ECG and then generate complete 12-lead ECGs. A previous protocol at the University of Oklahoma involved 200 subjects with early prototypes of the AC 12L device with the specific aim to validate that it accurately generated 12-lead ECGs as compared to simultaneously acquired FDA-cleared 12-lead ECGs. The prototype version of the AliveCor 12L ECG System simultaneously measured four channels of ECG (leads I, II, V2, V4), calculated the remaining limb leads as is standard for 12-lead ECGs (Leads III, aVR, aVL, aVF) and synthesized the remaining 4 precordial ECG leads (V1, V3, V5, V6). This protocol will serve to validate the production version of the system against standard 12-Lead ECGs for the diagnosis of STEMI and NSTEMI in patients admitted to the Emergency Department or directly to the Cardiac Cath Lab for the evaluation of chest pain. It is anticipated that the waveforms for each of the 12 leads from the AC 12L ECG System will be highly correlated with the corresponding leads from the comparator commercially available 12-lead ECG devices used at participating sites. The purpose of this study is to clinically validate that the four-channel AC 12L ECG device can enable the diagnosis of STEMI and NSTEMI in a non-inferior manner to existing 12-lead ECG devices.

TWIN-SCD STEMI is a multicentric prospective, non-randomized pilot study designed to establish a multiparametric model for predicting life-threatening ventricular arrhythmias in patients experiencing their first myocardial infarction. The primary objective of the study is to develop an algorithm with superior predictive performance (sensitivity and specificity) compared to the currently used criterion for the implantation of a cardiac defibrillator, which is a left ventricular ejection fraction (LVEF) of less than 35%.

Patients who have survived a myocardial infarction (MI) are at increased risk for sudden cardiac death (SCD) caused by ventricular tachycardia and ventricular fibrillation. A severely reduced left ventricular ejection fraction (LVEF) as a rough overall measure of impaired heart function after MI was shown to indicate a higher risk for SCD. Based on this observation, two landmark randomised trials, MADIT II and SCD-HeFT, were conducted between end of the 1990s and early 2000s. These trials compared the survival of patients with severely reduced LVEF who received an implantable cardioverter-defibrillator with the survival of patients being on medical therapy alone. They reported a significantly better survival of patients in the defibrillator arm and led to international guideline recommendations for routine implantation of defibrillators in survivors of MI with severely impaired LVEF as a means for primary prevention of SCD. Since then, the management of these patients has changed dramatically with the advent of a series of novel drug classes that reduce not only mortality but specifically SCD leading to a substantial decrease of the sudden death rates as well as of the rates of appropriate defibrillator therapies implanted for primary prevention of SCD. At the same time, the complication rates associated with the defibrilllator therapy remain significant without obvious decrease. Thus, the risk-benefit of routine defibrillator implantation for primary prevention of SCD in patients with severely reduced LVEF has substantially changed since the conduction of the landmark trials that established this therapy. Due to the inherent risks and considerable costs of the defibrillator, a novel randomised adequately powered assessment of the potential benefit or harm of the defibrillator in survivors of MI with reduced LVEF under contemporary optimal medical treatment (OMT) appears imperative. OBJECTIVE: To demonstrate that in post-MI patients with symptomatic heart failure who receive OMT for this condition, and with reduced LVEF ≤ 35%, OMT without ICD implantation (index group) is not inferior to OMT with ICD implantation (control group) with respect to all-cause mortality.

Rationale: Pump failure due to acute myocardial infarction (AMI) can lead to cardiogenic shock (CS): a state of low blood flow to end-organs with subsequent multi-organ failure that is associated with high mortality rated. The first line pharmacologic treatment strategy in CS is noradrenaline. This vasopressor drug is used to maintain adequate blood pressures. The assumption is that a mean arterial blood pressure (MAP) ≥ 65 mmHg will improve flow and thereby tissue perfusion of myocardium and other tissues (e.g. renal). However, there is no evidence that an increase in MAP, if achieved by noradrenaline, leads to greater end-organ blood flow and better outcomes. Objective: With this study the investigators aim to investigate the (cost-)effectiveness of reduced noradrenaline in patients with CS by using a lower MAP target of ≥ 55 mmHg, compared to ≥ 65 mmHg. The investigators hypothesize that reduced use of noradrenaline will improve overall survival and decrease renal failure requiring renal replacement therapy. Study design: Open label, randomized controlled multicenter trial Study population: Adults patients with CS due to AMI Intervention: Treatment strategy of reduced noradrenaline, by using a lower MAP target ( ≥ 55 mmHg). Main study endpoint: composite of all-cause mortality and severe renal failure leading to renal replacement therapy within 30-days after randomization.