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193 active trials for Myocardial Infarction

Quality and Safety of Initial Management for ST-segment Elevation Myocardial Infarction

This is a multicenter multidisciplinary study designed to investigate patient, provider, and system-related factors that are associated with the quality and safety of initial management for suspected ST-segment elevation myocardial infarction (STEMI) evolving for less than 12 hours in daily practice. The primary hypotheses are that delayed reperfusion therapy for suspected STEMI independently relates to provider practice patterns and system barriers. It is further postulated that non-compliance with target delays in implementing percutaneous coronary intervention (PCI) or fibrinolytic therapy is associated with worse in-hospital clinical outcomes. The secondary hypotheses are that the delivery of acute reperfusion therapy within target delays is associated with increased rates of false-positive cardiac catheterization laboratory activation, inadvertent fibrinolytic therapy, and bleeding events. The project will be conducted in three emergency medical services and 23 public and private (for-profit and non-for-profit) acute care hospitals in Northern Alps in France. Data over the index hospital stay period will be retrospectively collected for all the patients included in an ongoing prospective regional hospital-based clinical registry of suspected STEMI from October, 1st, 2002 to December, 31, 2014. Inclusion of 7435 patients is anticipated. In this observational retrospective study, no specific intervention is assigned to participants. All diagnostic testing, procedures, and medication ordering are performed at the discretion of attending physicians. No enrollment or follow-up visits are planned. The primary effectiveness outcome is timely acute reperfusion therapy. The secondary effectiveness outcomes include false-positive cardiac catheterization laboratory activation for catheterization candidates and inadvertent fibrinolytic therapy. The secondary medical outcomes include in-hospital all-cause mortality, major adverse cardiovascular events, and major bleeding events. Multivariable logistic regression model will be developed to identify baseline characteristics that are independently associated with timely acute reperfusion therapy. Propensity score analysis will be performed for comparing clinical outcomes between timely acute reperfusion therapy recipients and non-recipients.

Start: May 2017

Cardiovascular Complications and COVID-19 (CovCardioVasc-Study)

Patients with COVID-19 in the Intensive Care Unit (ICU) or hospitalized with severe form have a poor prognosis (almost 30% rate of death). They present often a high cardiovascular risk profile (almost 30% of hypertension and 19% of diabetes). Troponin has been described to be elevated in a high proportion of patients (one fifth of all patients and 50% of non-survivors) suggesting the possibility of cardiomyopathies. High levels of DDimers (81% of non survivors) and fibrin degradation products are also associated with increased risk of mortality suggesting also the possibility of venous thromboembolism. Therefore, screening for cardiomyopathies and venous thromboembolism could represent an important challenge for patients with COVID-19 management.

Start: February 2020

Impact of Peripheral Vascular Stiffness Assessment on Risk Prediction in Patients With Myocardial Infarction

Risk assessment after myocardial infarction is critical in daily practice and evolution toward heart failure especially diastolic heart failure remains a key issue. All consecutive patients with myocardial infarction (either STEMI or NSTEMI but excluding type 2 MI) presenting at university hospital of Lille within 48 hours after symptom onset will be recruited in the RIGID-MI registry. The RIGID-MI study proposes to deeply evaluate at 1 month after MI: peripheral vascular disease, vascular stiffness, ventriculo-arterial coupling and other usual risk factors. The main objective is to identify clinical, biological and imaging parameters associated with poor prognosis, especially evolution toward diastolic heart failure, recurrence of MI, and bleeding.

Start: March 2021

CMR Findings in COVID-19 Patients Presenting With Myocardial Infarction

To compare myocardial injury in COVID 19 patients presented with myocardial infarction and non COVID Patients presented with myocardial infarction evaluated with CMR

Start: January 2021

Safety and Efficacy of LMWH Versus Rivaroxaban in Chinese Patients Hospitalized With Acute Coronary Syndrome

H-REPLACE trial is a prospective, randomized, open-label, active-controlled, multicenter study in participants with ACS (STEMI or NSTEMI, unstable angina). All eligible participants receiving background treatment of aspirin plus clopidogrel or ticagrelor will be randomly assigned to either oral rivaroxaban 2.5 mg twice daily or rivaroxaban 5 mg twice daily or subcutaneous (SC) enoxaparin 1mg/kg twice daily until hospital discharge or 12 hours before revascularization therapy for a maximum of 8 days.

Start: January 2018

Paroxetine-mediated GRK2 Inhibition to Reduce Cardiac Remodeling After Acute Myocardial Infarction

This 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.

Start: October 2017

Utilising Lifemap to Investigate Malignant Arrhythmia Therapy

It is universally recognised that current methods for risk stratification of sudden cardiac death (SCD) are limited. A novel SCD risk marker, the Regional Restitution Instability Index (R2I2), measures the degree of heterogeneity in electrical restitution using data obtained from a standard 12 lead ECG acquired during an invasive electrophysiological study. In an ischaemic cardiomyopathy (ICM) cohort of 66 patients, an R2I2 of ≥1.03 identified subjects with a significantly higher risk of ventricular arrhythmia (VA) or death (43%) compared with those with an R2I2 <1.03 (11%) (P=0.004). This study will use non-invasive techniques to acquire electrical restitution data: exercise and pharmacological stress, and will incorporate body surface potential mapping to develop a non-invasive and high-resolution form of R2I2. Suitable patients will be recruited into a prospective, observational study. HYPOTHESES: PRIMARY: R2I2 is predictive of ventricular arrhythmia (VA) / SCD in patients with ICM. The exercise stress protocol will create a dynamic range of heart rates that allows ECG quantification of electrical restitution heterogeneity that correlates with invasive R2I2 and is predictive of VA/SCD. The pharmacological stress protocol will create a dynamic range of heart rates that allows ECG based quantification of electrical restitution heterogeneity that correlates with invasive R2I2 and is predictive of VA/SCD. SECONDARY: A high-resolution electrical map acquired using body surface potential mapping will correlate with R2I2 and these data can be included in the R2I2 calculation to improve its prediction of SCD/VA. Serial measurement of R2I2 will produce consistent values.

Start: October 2013

Establishing the Incidence of Tako-tsubo Cardiomyopathy in Scotland

Acute stress-induced (Tako-tsubo) cardiomyopathy presents like a heart attack and is triggered by intense emotional or physical stress. Although heart arteries are unobstructed, the risk of death is similar to a heart attack. The purpose of the STARR study is to identify all cases of Tako-tsubo in Scotland since 2010.

Start: July 2016

The Next Leap in Cardiac Magnetic Resonance Imaging:Cycling the Field

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.

Start: August 2020

The Norwegian Trial of Physical Exercise After Myocardial Infarction

Myocardial infarction (MI) remains the main cause of death in Europe with about 2 million deaths annually. According to WHO, 30 % of deaths caused by MI could be prevented if the populations adhere to official guidelines for physical activity. However, secondary prevention trials in MI patients have been of insufficient size or quality to provide conclusive evidence that physical activity reduces the risk of death or recurrent cardiovascular diseases. NorEx is the first study able to provide such evidence. NorEx is a registry-based prospective, three-arm, randomized multicenter secondary prevention clinical trial with blinded end-point evaluation (PROBE design). The aim of the study is to investigates whether, and to what extent, moderate to high intensity supervised physical activity will reduce the risk of recurrent cardiovascular disease and death among people who have suffered a myocardial infarction. The intervention group consists of Approximately 4500 participants who will be trained to exercise for 3,5 years under supervision of a personal trainer. The study design includes two control groups each consisting of 4500 patients.The primary composite endpoint is time to all-cause death, nonfatal acute myocardial infarction, nonfatal stroke, and coronary revascularization, whatever comes first during 3.5 years of follow-up. The study is powered to detect a 15 % difference in the incidence of the primary endpoint between the intervention group and the control groups. Novel health IT technology was specifically designed for NorEx, including a smart watch, a NorEx mobile application and a manager portal which allows the trainers to interact with the participants. Follow-up of the participants will be through national health registries for up to 10 years after study completion.

Start: October 2020

Mental Stress and Myocardial Ischemia After MI: Sex Differences, Mechanisms and Prognosis

The purpose of this study is to look at the link between emotional stress and heart disease in men and women. Taking part in this study involves one clinic visit, one week of at home monitoring, and follow up phone calls every 6 months for 3 years.

Start: February 2020

Meta-analysis of Fish Oil Supplementation and Cardiovascular Outcomes in Diabetes

Fish oil contains a large amount of long-chain omega-3 polyunsaturated fatty acids, which are considered an important component of a healthy diet. As many patients do not eat fish, supplementation with fish oil is a common strategy to provide sufficient amounts of these particular fatty acids in daily life. Fish oil supplementation has been investigated for decades for its cardio-protective effects and its ability to lower serum triglycerides. People with diabetes mellitus have an increased risk for cardiovascular events and show alterations in lipids with high triglycerides. Whether there is a benefit of fish oil supplementation in this high risk group remains unclear with major international diabetes associations recommending against the use of fish oil supplements. The European Association for the Study of Diabetes (EASD) has not made any recommendations about the use of fish oils in people with diabetes since 2004. To inform the update of the EASD clinical practice guidelines for nutrition therapy, the Diabetes and Nutrition Study Group (DNSG) of the EASD has commissioned the proposed systematic review and meta-analysis of randomized controlled trials of the effect of fish oil supplementation on cardiovascular outcomes in people with diabetes and use the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to assess the certainty of the evidence.

Start: March 2020

Effect of Colchicine in Patients With Myocardial Infarction

Over the past years, a substantial volume of evidence has accumulated identifying inflammatory processes as key mediators of the deleterious effects of ischemia/reperfusion-related phenomena in patients presenting with ST-segment-elevation myocardial infarction (STEMI). Nevertheless, equally impressive is the lack of clinically applicable therapeutic strategies that could mitigate these processes, thus providing significant cardioprotection. Despite the well-known fact that inflammation plays an important role in coronary artery disease development and progression, there have been few attempts to systematically examine the potential role of anti-inflammatory treatment in this setting, possibly because of a lack in anti-inflammatory agents without the adverse cardiovascular safety profile of corticosteroids and nonsteroidal anti-inflammatory drugs. Colchicine is a substance with potent anti-inflammatory properties, having a unique mechanism of action, which allows for safe use in patients with cardiovascular disease. The purpose of the present clinical study is to test the hypothesis that a short course of treatment with colchicine could lead to reduced major adverse cardiovascular events (MACE) in acute MI.

Start: December 2020

CMR Based Prediction of Ventricular Tachycardia Events in Healed Myocardial Infarction (DEVELOP-VT)

Fibrotic tissue is known to be the substrate for the appearance of scar-related reentrant ventricular arrhythmias (VA) in chronic ischemic cardiomyopathy (ICM). Late gadolinium enhancement cardiac magnetic resonance (LGE-CMR) has proven to be a useful technique in the non-invasive characterization of the scarred tissue and the underlying arrhythmogenic substrate. Previous studies identified the presence of significant scarring (> 5% of the left ventricular -LV- mass) is an independent predictor of adverse outcome (all-cause mortality or appropriate ICD discharge for ventricular tachycardia or fibrillation) in patients being considered for implantable cardioverter-defibrillator (ICD) placement. Parallelly, the presence of heterogeneous tissue channels, which correlate with voltage channels after endocardial voltage mapping of the scar, can be more frequently observed in patients suffering from sustained monomorphic ventricular tachycardias (SMVT) than in matched controls for age, sex, infarct location, and left ventricular ejection fraction (LVEF). However, the lack of solid evidence and randomized trials make LVEF still the main decision parameter when assessing suitability for ICD implantation in primary prevention of sudden cardiac death (SCD). In a recent, case-control study, we identified the border zone channel (BZC) mass as the only independent predictor for VT occurrence, after matching for age, sex, LVEF and total scar mass. This BZC mass can be automatically calculated using a commercially available, post-processing imaging platform named ADAS 3D LV (ADAS3D Medical SL, Barcelona, Spain), with FDA 510(k) Clearance and CE Mark approval. Thus, CMR-derived BZC mass might be used as an automatically reproducible criterium to reclassify those patients with chronic ICM at highest risk for developing VA/SCD in a relatively short period of approx. 2 years. In the present cohort study, we sought to evaluate the usefulness of the BZC mass measurement to predict the occurrence of VT events in a prospective, multicenter, unselected series of consecutive chronic ischemic patients without previous arrhythmia evidence, irrespectively of their LVEF.

Start: August 2020

Serum Magnesium Levels in Desalination Tap Water and Outcomes in Acute Myocardial Infarction Patients

Association between serum magnesium and clinical outcome in patients with acute MI (AMI) with 1 year follow-up in 300 patients in regions supplied by desalinated drinking water (DSW) (Sheba MC) and 150 patients in regions with non-desalinated drinking water (DW) (Nahariya MC).

Start: May 2015

Association of Endothelial Function and Clinical Outcomes in Subjects Admitted to Chest Pain Unit

It is recognized that endothelial dysfunction is a major factor contributing to the atherogenic process. Abnormal function of the endothelium is detectable prior to obvious intimal lesions in patients with risk factors for atherosclerosis. Endothelial dysfunction is a systemic disorder and a key variable in the pathogenesis of atherosclerosis and its complications. Measurement of peripheral vasodilator response with fingertip peripheral arterial tonometry (PAT) technology (EndoPAT; Itamar Medical, Caesarea, Israel) is emerging as a useful method for assessing vascular function. EndoPAT may be a potential valid test increasing the accuracy, sensitivity and specificity for detection of subjects to chest pain unit (CPU) with chest pain but no obvious coronary artery disease (CAD). This is a relatively fast non-invasive bedside test, relatively low-cost and has no side effects. Therefore, the primary objective of the study is to test the hypothesis that abnormal endothelial function as assessed by EndoPAT testing will increase the prediction of the short (in-hospital) and long-term (1-year) outcome of patients presenting to the chest pain unit.

Start: October 2012

Peer-mentor Support for Older Vulnerable Myocardial Infarction Patients

BACKGROUND: Advanced treatment regimens have reduced cardiovascular mortality resulting in an increasingly older myocardial infarction (MI) population in need of cardiac rehabilitation (CR) , the majority (74%) is above 60 years. The positive effect of CR is well established; CR reduces cardiovascular mortality, lowers hospital admissions, and improves quality of life among patients with ischemic heart disease. These positive effects of CR has also been established among older patients. The inherent problem lies in the low attendance rate, often below 50%. Several studies, including studies from Denmark, have shown that low participation in CR is most prevalent among older, vulnerable female patients. The notion vulnerable covers patients with low socioeconomic position (SEP), patients with non-western background and patients living alone, as these groups have particularly low CR attendance. Effective interventions aiming at increasing CR attendance among these low attending groups are thus warranted and the current study will seek to address this. AIM: To test feasibility and acceptability of methods used in a peer-mentor intervention among older female and vulnerable post MI patients. DESIGN AND METHODS: The study is designed as a one arm feasibility study. Patients (n=20) are recruited by a dedicated research nurse before discharge from the cardiology department at Nordsjællands Hospital. Data is collected at three timepoints, baseline, 12 weeks and 24 weeks. The patients (mentees) are matched with peer-mentors. Peer-mentoring (i.e. mentoring by a person with a similar life situation or health problem as one self) is a low-cost intervention that holds the potential to improve CR attendance and improve physical and psychological outcomes among older patients. Peer-mentors are role models who can guide and support patients overcoming barriers of CR attendance. Peer-mentoring is unexplored in a CR setting among older, female and vulnerable MI patients; establishing the novelty of the current study.

Start: September 2020

Use of Abbott High Sensitivity Troponin I Assay In Acute Coronary Syndromes

Hypothesis: High sensitivity cTnI assays will have improved diagnostic accuracy for type 1 MI compared to contemporary cTnI assays. The primary objective of the study is to determine the performance of a high sensitivity cardiac troponin I (hs-cTnI) assay compared to a contemporary cTnI assay for the diagnostic accuracy of type 1 acute myocardial infarction (AMI). The diagnostic performance of Abbott's hs-cTnI assay will be evaluated. Investigators will assess the assay's ability to diagnose AMI earlier and to rule out AMI earlier. The sensitivity, specificity, positive predictive value and negative predictive value of the hs-cTnI assay will be evaluated with both a universal cut off as well as with gender and potentially age derived 99th percentile upper reference limits (URL). Investigators will evaluate delta hs-cTnI values (pre-specified absolute concentration and percent changes over time) for their ability to contribute to the negative predictive value and hence potentially lead to an earlier rule out of AMI (improved specificity). Additionally, investigators will assess delta changes of the hs-cTnI assay for their potential contribution to the clinical differentiation of type 1 and type 2 (supply demand mismatch) MIs. Lastly, investigators will compare the diagnosis of AMI based on the currently used contemporary assay to the hs-assay, to assess both the incidence of AMI as well as for the time to diagnosis.

Start: February 2014

Association Between Genetic Variant Scores and P2Y12 Inhibitor Effects

The goal of this study is to predict and prevent adverse drug events by investigating the impact of genetic variants, demographics, and environmental factors in subjects status post myocardial infarction and percutaneous coronary insertion who have experienced adverse drug events while on P2Y12 inhibitors.

Start: October 2020

The Impact of Early Follow-up on Readmission Rates in AMI Patients

With no prior prospective study to demonstrate the benefit of an early post-discharge follow-up appointment in reducing readmission rates in the post-myocardial infarction (MI patient population, we propose to conduct the first randomized, prospective trial to better elucidate the association between early and standard follow-up on readmission rates. The investigators hypothesize that unlike heart failure or advanced valvular disease patients, the benefit of early outpatient follow-up in reducing readmission of post-MI patients will be less clear. Thus, the investigators primary aim will be to determine the effect of early outpatient follow-up post-discharge on 90 day all-cause readmission rates (exclusive of planned readmissions known at the time of discharge). Secondary aims are to describe 1) causes of readmissions within 90 days, 2) any cardiovascular-related complications and any deaths that occur from discharge through 90 days, 3) 30-day readmission rates and 4) median time to readmission among those readmitted. Finally, the investigators will examine the distribution of demographic, clinical and socioeconomic characteristic according to readmission vs. no readmission. The investigators do not expect to have sufficient endpoints for full predictive modeling, but believe this exploratory work will provide a foundation for future studies. The investigators postulate that the design and methodology of our current study could be used to answer similar questions in other subsets of patients.

Start: March 2014