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NSTEMI clinical trials

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NCT ID: NCT06166407 Not yet recruiting - Clinical trials for Myocardial Infarction

Breisgau Pheno Heart Study

Start date: April 2024
Phase:
Study type: Observational

Coronary heart disease and its acute complication, myocardial infarction (MI), represent the leading causes of death in Europe and the United States. Although novel treatment strategies have helped to improve survival in patients with MI, a large proportion of patients develops heart failure and is at risk of life-threatening arrhythmias. Complications arising after MI constitute a severe burden not only for the patients themselves, but also for health care systems worldwide. The likelihood of these complications depends on the area of myocardial tissue lost and the process of myocardial repair and scar tissue formation after MI ('remodeling') which are modified by the local and systemic immune response after MI. The immune response is critical after myocardial infarction. In particular, sustained overactive and prolonged inflammatory reactions lead to accentuated myocardial damage and dysfunction. Important mediators of the inflammatory reaction after MI are monocytes, T-cells, B-cells and hematopoietic stem and progenitor cells. Following MI, myeloid cells derived from the hematopoietic system drive a sharp increase in systemic leukocyte levels that correlates closely with mortality. T- and B-cells in particular act in response to specific antigens. Most of the data regarding the inflammatory response after MI, however, are derived from animal models. The immunological phenotypes after MI and their association with clinical outcome in humans are insufficiently characterized. Aims: The aim of this project is to provide establish clinically and immunologically well-characterized cohort of patients after MI This will aid in identifying novel prognostic cellular and humoral biomarkers that may be used to identify patients at a high inflammatory and immune risk and to guide clinical management. Furthermore, these mediators, in the future, may be targeted by novel antigen-specific immunomodulatory approaches. Patients with myocardial infarction (STEMI and NSTEMI) will be recruited after PCI within 24h and receive a structured follow-up. Clinical read-outs include a detailed and standardized patient history, clinical examination, standard blood work, coronary angiography, ECG, echocardiography and for subgroups, MRI. Patients will present for study visits at 6 weeks, 3 months and 12 months after the initial event. Blood will be sampled at the inclusion and during follow-up visits. Peripheral blood mononuclear cells and plasma will be stored at the Cardiovascular BioBank (CVBB) and FREEZE, both institutions at the University Hospital in Freiburg. Major adverse cardiac events (myocardial infarction, stroke, hospitalization for heart failure, cardiovascular death) will be recorded using telephone interviews and standardized queries to the local authorities. Several laboratory read-outs are planned including flow cytometry, mass cytometry, single cell RNA sequencing, T cell and B cell receptor sequencing and bulk-RNA-sequencing. In an initial approach we aim to recruit 400 patients with MI, of which we expect ≈40 to develop ischemic cardiomyopathy. Differences in immunological profiles between patients that develop MI and a propensity-matched control group will then be analyzed and correlated with clinical outcome data.

NCT ID: NCT05957172 Withdrawn - Cardiac Disease Clinical Trials

Mobile Advanced Multi-Parameter Reporting in Patients Wearing a Novel Device: Utilization During Cardiac Rehabilitation

MAPS-III
Start date: January 2023
Phase:
Study type: Observational

Advanced remote multi-parameter reporting during cardiac rehabilitation (MAPS-III). The primary purpose of this observational study is to collect baseline information of cardiac rehabilitation usage in the US for post-myocardial infarction (MI) patients with EF > 35% while wearing the ZOLL AMS device for 30 to 60 days. Secondary data on biometrics, arrhythmias, symptoms, and healthcare utilization will provide additional background information on this population during the early post-MI cardiac rehabilitation period.

NCT ID: NCT05800951 Enrolling by invitation - Clinical trials for Acute Myocardial Infarction

Can Escalation Reduce Acute Myocardial Infarction Mortality in Cardiogenic Shock

CERAMICS
Start date: July 22, 2022
Phase:
Study type: Observational [Patient Registry]

The CERAMICS study is designed to more clearly delineate the current care of acute myocardial infarction with cardiogenic shock (AMICS) patients who are treated with mechanical circulatory support (MCS) devices in the United States with significant experience in MCS, all of whom have the capability of MCS escalation on-site. Study enrollment is targeted at 120 patients at 20 hospital sites, evaluating clinical outcomes, and focusing on outcomes MCS escalation decision making and ICU level management.

NCT ID: NCT05764057 Recruiting - STEMI Clinical Trials

DAPAgliflozine to Attenuate Cardiac RemOdeling afTEr aCuTe myOcardial Infarction

DAPAPROTECTOR
Start date: June 12, 2023
Phase: Phase 3
Study type: Interventional

Recent clinical trials have proven the cardiovascular benefits of new medications for patients with heart failure with reduced ejection fraction (HFrEF), especially sodium-glucose co-transporter 2 (SGLT2) inhibitors. There are no existing randomized clinical trials evaluating the efficacy and safety of dapagliflozin (nor any other SGLT2-inhibitor) to limit cardiac remodeling in patients with acute myocardial infarction (AMI) and left ventricular (LV) dysfunction. Preventing cardiac remodeling, an established predictor of subsequent heart failure (HF) and cardiovascular death, is likely to translate into benefit in reducing clinical events in post-MI patients.

NCT ID: NCT05409716 Completed - Clinical trials for Coronary Artery Disease

Compressive Elastic Dressing Versus TR Band

Band Vs Gauze
Start date: August 1, 2020
Phase: N/A
Study type: Interventional

Radial approach is widely established in cardiac diagnostic and therapeutic treatments. It has been shown to decrease bleeding, vascular problems, and mortality rates when compared to the femoral approach. It also offers better comfort to patients through early mobility and lowers hospital expenses. Previously, there were no specific devices for radial artery hemostasis. Many different types of dressings were used in various hospitals with no standardization. This raises the question of whether specific devices surpass dressings in terms of patient comfort, time required to maintain hemostasis, and vascular complications. The primary goal of this study was to examine the effectiveness of compression dressings and hemostatic wristbands on patients undergoing cardiac procedures via radial approach in terms of patient comfort, time required to maintain hemostasis, and vascular problems. The hemostatic wristband TR BandR (Terumo Corporation, Tokyo, Japan) was utilized in one group, while compressive elastic dressing, standardized as 13 threads gauze overlapped, opened, longitudinally pleated once and wrapped, making a 5-cm long cylinder, 1-cm in height, was used in the other.

NCT ID: NCT05263778 Not yet recruiting - Clinical trials for Cardiovascular Diseases

Cholesterol Lowering Via Bempedoic Acid/Ezetimibe, an ACL-Inhibiting Regimen in Acute Coronary Syndrome Study

Start date: March 2022
Phase: Phase 4
Study type: Interventional

The overall objective of the Cholesterol Lowering via Bempedoic Acid/Ezetimibe, an ACL-Inhibiting Regimen in Acute Coronary Syndrome ACS (CLEAR ACS) study is to determine the efficacy, safety, and tolerability of bempedoic acid/ezetimibe (BA/E) in a contemporary and real-world population, enriched for older adults, women, and underrepresented racial/ethnic groups, of adults with a recent acute coronary syndrome (ACS) event independent of use of statin therapy before the ACS event.

NCT ID: NCT05175261 Recruiting - STEMI Clinical Trials

Assessment of Individual Risk of Cardiovascular Events by Platelet FcGammaRIIa

Start date: January 20, 2022
Phase:
Study type: Observational

This is a Prospective, Observational Multicenter Non-Interventional Cohort Study. The primary objective is to determine whether platelet expression of FcγRIIa is associated with risk of myocardial infarction (MI), stroke and death. Secondary objectives include: 1) Develop a score that combines clinical characteristics plus platelet expression of FcγRIIa to determine the risk of MI, stroke, and death; and 2) Determine whether platelet expression of FcγRIIa is associated with risk of major bleeding. The primary endpoint is the composite of death, MI and stroke. A secondary endpoint is the incidence of clinically significant bleeding according to the Bleeding Academic Research Consortium (BARC) scale type 2-5. Approximately 800 male and female subjects with confirmed MI [ST-segment elevation MI (STEMI) or non-ST-segment elevation MI (NSTEMI)] will be enrolled before hospital discharge for the index event. Approximately 10 sites in the United States will participate in this study. It is anticipated that it will take approximately 12 months to enroll approximately 800 subjects. The study and subject follow-up will continue until 1) at least 80 ischemic events (MI, stroke, and death) have occurred, and 2) the last subject enrolled has completed 18 months of follow-up.

NCT ID: NCT04988672 Recruiting - Clinical trials for Myocardial Infarction

OPTIMISER Registry - A Prospective Cohort Study to Describe the OPTIMal Management and Outcomes of PatIents PreSEnting With Acute MyocaRdial Infarction

OPTIMISER
Start date: January 1, 2021
Phase:
Study type: Observational

The purpose of the OPTIMISER Registry is to prospectively and retrospectively collect baseline, clinical and procedural data in patients who present with AMI and are treated with PCI as well as prospectively collect the clinical outcome data. Outcomes will be compared in different clinical subgroups. The impact of PCI in AMI in general as well as cardiovascular outcomes after AMI will be assessed.

NCT ID: NCT04900155 Active, not recruiting - Covid19 Clinical Trials

Evaluation of the Effect of Long-term Lipid-lowering Therapy in STEMI Patients With Coronavirus Infection COVID-19

CONTRAST-3
Start date: November 20, 2020
Phase: N/A
Study type: Interventional

It is planned to include 200 patients hospitalized with primary myocardial infarction with and without ST segment elevation (STEMI or NSTEMI) in combination with COVID-19 within the first 15 days from the disease onset. The total follow-up period is 96 weeks. Hypotheses: 1. An integrated approach in assessing myocardial contractility, regulation of the heart and the structural and functional state of arteries will make it possible to more accurately assess the heart pumping function; explain the mechanisms of the relationship between left ventricular (LV) contractile function and its volumetric indices; to study the mechanisms of ventriculo-arterial coupling and the influence of autonomic regulation, the role of markers of the sudden cardiac death (late ventricular potentials, pathological turbulence of the heart rate, dispersion of the QT interval). 2. In patients who have had myocardial infarction in combination with the new coronavirus infection SARS-CoV-2 (COVID-19), long-term highly effective lipid-lowering therapy, regardless of the drugs prescribed, has an antiarrhythmic effect and has a beneficial effect on the autonomic regulation of the heart rate. Highly effective lipid-lowering therapy leads to an improvement in LV contractility and structural and functional properties of the large arteries. Methods and variables 1. Office blood pressure 2. 12-lead ECG 3. Coronary angiography. Percutaneous coronary intervention 4. Chemistry blood test 5. 2D and 3D transthoracic echocardiography (Vivid GE 95 Healthcare (USA) 6. Multi-day 3-lead ECG monitoring with assessment of the parameters of myocardial electrical instability. 7. Ultrasound of common carotid arteries using high-frequency radio-frequency signal technology 8. Applanation tonometry (SphygmoCor, AtCor, Australia) 9. Assessment of the arterial stiffness by volume sphygmography. 10. Flow-mediated vasodilation 11. Six-minute walk test 12. Computer pulse oximetry (PulseOx 7500 (SPO medical, Israel) 13. Adherence to Treatment: Counting remaining pills and completing the Morisky-Green Questionnaire 14. Assessment of quality of life 15. Assessment of physical activity: International Questionnaire On Physical Activity - IPAQ 16. Hospital Anxiety and Depression Scale (HADS)

NCT ID: NCT04861519 Completed - Stable Angina Clinical Trials

Pivotal, Single-arm Clinical Trial to Assess the Efficacy and Safety of the MedHub AutocathFFR Software Device

AutocathFFR
Start date: May 9, 2021
Phase:
Study type: Observational

Prospective (analysis of retrospective data), multi-center, observational, single-arm study. This structure was selected as the "worst case" due to the fact that it represents real life usage of invasive FFR measurement is performed mostly in "gray zone" cases, which are that their severity cannot be determined intuitively and based on the physician eyeball. By using real-world historical data of invasive FFR, the analysis of the obtained data can ensure that the study results are expected to include invasive FFR results that are in the grey zone, when invasive FFR is used in real life and represent the real expected use of the product. Furthermore, the analysis of the data obtained in the studies with these similar devices measuring FFR obtained from angiograms was actually performed in a retrospective manner. That is, although the angiographic images and pressure wire recordings were obtained in real-time, due to the need to mark the vessel in real-time and obtain specific projections during the procedure without which the FFR cannot be calculated, the primary endpoint (sensitivity and specificity) and accuracy were determined in all studies by a post-hoc review by a similar independent QCA core laboratory. The invasive FFR data, as well as the software generated FFR data were reviewed post-hoc by a core laboratory or even at the company.