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Infarction clinical trials

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NCT ID: NCT05435391 Enrolling by invitation - Clinical trials for Myocardial Infarction or Chest Pain

ROMIAE (Rule-Out Acute Myocardial Infarction Using Artificial Intelligence Electrocardiogram Analysis) Trial

ROMIAE
Start date: March 16, 2022
Phase:
Study type: Observational

This study is a prospective multicenter observational study for external validation and model advancement of a deep learning based 12-lead electrocardiogram analysis algorithm targeting adult patients presenting to the emergency department with chest pain and acute myocardial infarction equivalent symptoms. About 9,000 adult patients will be enrolled at 20 emergency medical centers in Korea. Artificial intelligence algorithms are manufactured by Medical AI Co., Ltd. It is an advanced version based on the model developed and published in 2020. It had the diagnostic performance of area under the receiver operating curve 0.901 and 0.951 for acute myocardial infarction and ST-segment elevation myocardial infarction, respectively. The primary endpoint is a diagnosis of acute myocardial infarction on the day of the emergency center visit, and the secondary endpoint is a 30-day major adverse cardiac event. From March 2022, patient registration will begin at centers that have been approved by the Institutional Review Board. This is the first prospective multicenter emergency department validation study for a 12-lead electrocardiogram artificial intelligence algorithm to diagnose acute myocardial infarction. This study will give insight into the direction of future development by verifying whether the deep learning algorithm works well for patients visiting the real-world adult emergency medical center.

NCT ID: NCT05175898 Enrolling by invitation - Clinical trials for Acute Myocardial Infarction

ECMELLA vs. ECMO on 30-day Mortality

Start date: February 2022
Phase:
Study type: Observational

This international, multicenter cohort study aims to investigate outcomes after treatment with extracorporeal cardiopulmonary resuscitation (eCPR) during cardiac arrest.

NCT ID: NCT05166447 Enrolling by invitation - Obesity Clinical Trials

Twenty-year Follow-up of the Inter99 Cohort

Start date: September 13, 2021
Phase:
Study type: Observational

Being born small increases your risk of developing Type 2 diabetes (T2D) with age. Furthermore, data even suggest that some of the diseases ("complications") in the eyes, kidneys, nerves, liver, blood vessels and heart often seen in T2D patients may not only be due to high blood sugar levels, but rather they to some extent are due to reduced growth in your mother´s womb. The Inter99 cohort included 6784 Danish citizens aged 30 to 60 years when established 20 years ago. Data from the Inter99 cohort showed a strong role of low birth weight (LBW) on T2D risk. The aim is now to reexamine risk of T2D and complications in all the alive 6004 elderly Inter99 participants. Importantly, today there are available techniques to perform detailed examinations for even the earliest signs of complications in both subjects with and without diabetes, and the results of this study will altogether provide important new insights into both the origin and classification of T2D and associated complications. It is hypothesized that being born with lower birth weights increases the adult risk of T2D and heart disease and associated complications in the large and smaller blood vessels.

NCT ID: NCT04974320 Enrolling by invitation - Prognosis Clinical Trials

Rapid Identification of MINOCA Based on Novel Biomarkers

Start date: June 5, 2021
Phase:
Study type: Observational

Among the patients diagnosed as acute myocardial infarction by coronary angiography, 5%-25% of the patients did not find coronary artery obstructive lesions. These patients do not need PCI. The discovery and verification of clinical protocols for accurate identification of myocardial infarction in the absence of obstructive coronary artery disease(MINOCA)is a major issue that needs to be addressed.Novel biomarkers like grow stimulation expressed gene 2(ST2)can indicate the degree of coronary artery obstruction, copeptin is a biomarker of cardiac emergency state. No clinical studies have been conducted to evaluate whether the novel biomarkers combination regimen can diagnose or exclude MINOCA. Our research aims to establish and validate a model for the recognition of MINOCA based on novel biomarkers (ST2, copeptin) and to evaluate the prognostic value of novel biomarkers among patients with acute chest pain.

NCT ID: NCT04970238 Enrolling by invitation - Heart Failure Clinical Trials

Effect of Levosimendan on Left Ventricular Systolic Function and Heart Failure After PCI in Patients With Acute Anterior Myocardial Infarction

Start date: October 2021
Phase: Phase 4
Study type: Interventional

Reperfusion therapy for acute ST segment elevation myocardial infarction (STEMI) can significantly reduce mortality, but patients may still have heart failure and adverse cardiovascular events due to massive myocardial loss. About 20% of patients present with acute heart failure (AHF) at admission, It is the most important cause of hospital death in acute myocardial infarction. Because of the large necrotic area of acute anterior myocardial infarction, heart failure still occurs in a considerable number of patients even after revascularization (PCI). Myocardial protection of ischemic myocardium is a hot topic in clinical research. Both ESC and Chinese heart failure guidelines recommend levosimendan for the treatment of acute decompensated heart failure. A large number of studies have proved that levosimendan can significantly reduce myocardial injury and improve cardiac function in patients with acute STEMI complicated with left ventricular dysfunction and cardiogenic shock compared with placebo. Basic research has confirmed that levosimendan can reduce the myocardial infarction area after acute coronary occlusion, improve the left ventricular function, and exert the effects of anti myocardial ischemia, myocardial injury, myocardial fibrosis, ventricular remodeling and anti apoptosis. However, there is still a lack of early preventive application of levosimendan in acute anterior myocardial infarction after PCI to improve ventricular remodeling and reduce the incidence of heart failure. The purpose of this study was to investigate the effect of early prophylactic levosimendan on left ventricular remodeling, ischemic myocardial protection and the development of heart failure in patients with acute anterior myocardial infarction after PCI.

NCT ID: NCT04957719 Enrolling by invitation - Clinical trials for Acute Myocardial Infarction

Selatogrel Outcome Study in Suspected Acute Myocardial Infarction

SOS-AMI
Start date: August 14, 2021
Phase: Phase 3
Study type: Interventional

This study will randomize patients recently discharged from the hospital with a confirmed diagnosis of type 1 acute myocardial infarction (Thygesen et al. 2018) and having additional cardiovascular risk factors.

NCT ID: NCT04864691 Enrolling by invitation - Clinical trials for Intracranial Artery Occlusion With Infarction

Endovascular Recanalization and Standard Medical Management for Symptomatic Nonacute Intracranial Artery Occlusion Trial

Start date: January 1, 2020
Phase: Early Phase 1
Study type: Interventional

Background The management of patients with symptomatic nonacute intracranial artery occlusion (sNA-ICAO), which is a special subset with high morbidity and a high probability of recurrent serious ischemic events despite standard medical therapy (SMT), has been clinically challenging. Some small-sample clinical studies have also discussed endovascular recanalization for sNA-ICAO; however, there is currently a lack of evidence from multicenter, prospective, large-sample cohort trials. The aim of our present study was to evaluate the technical feasibility and safety of endovascular recanalization for sNA-ICAO. Methods and analysis: Our group is currently undertaking a multisite, nonrandomized cohort, prospective registry study enrolling consecutive patients presenting with sNA-ICAO at 15 centers in China between May 1, 2020, and April 30, 2023. A cohort of patients who received SMT and a cohort of similar patients who received ER plus SMT were constructed and followed up for 2 years. The primary outcome is the composite of stroke/TIA within 2 years following enrollment and stroke/TIA ipsilateral to the target vessel. The secondary efficacy outcome includes the following two parts: 1) the incidence of stroke/TIA ipsilateral to the target vessel within 30 days and 90 days in both groups; 2) the all-cause mortality, mRS score, NIHSS score and cognitive function at 30 days, 90 days, 8 months, 12 months and 24 months for both groups, including the MRI, CTA/MRA, CTP or MRP results in patients with internal carotid artery or middle cerebral artery occlusion as well as CTA in patients with basilar or vertebral artery occlusion at 90 days, 12 months and 24 months. Descriptive statistics and linear/logistic multiple regression models will be generated. Clinical relevance will be measured as relative risk reduction, absolute risk reduction and the number needed to treat. Ethics and dissemination This study protocol was reviewed and approved primarily by Beijing Tiantan Hospital, the Capital Medical University Medical Ethics Committee, and the institutional review boards of all partner sites. The study is being externally monitored, and the results will be published in open-access peer-reviewed scientific journals and presented to academic and policy stakeholders.

NCT ID: NCT04617639 Enrolling by invitation - Clinical trials for Myocardial Infarction

The Norwegian Trial of Physical Exercise After Myocardial Infarction

NorEx
Start date: October 29, 2020
Phase: N/A
Study type: Interventional

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 investigate 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 3185 participants who will be trained to exercise for 4 years under supervision of a personal trainer. The study design includes two control groups each consisting of approximately 3200 patients.The primary composite endpoint is time to all-cause death, nonfatal acute myocardial infarction or nonfatal stroke, whatever comes first during 4 years of follow-up. The study is powered to detect a 20 % 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.

NCT ID: NCT04259853 Enrolling by invitation - Clinical trials for ST Elevation Myocardial Infarction

Quantitative Fractional Ratio-guided Revascularization in STEMI Patients With Multi-vessel Disease

Start date: January 30, 2020
Phase: N/A
Study type: Interventional

About half of patients with ST-segment elevation myocardial infarction (STEMI) have multi-vessel lesions (> 50% diameter stenosis). But how to deal with the non-culprit vessels is still controversial. Previous studies have shown that flow fractional reserve (FFR)-guided revascularization on non-culprit vessels can further improve prognosis of such patients. However, FFR requires the use of pressure guidewire and special drugs such as adenosine to maximize induction of hyperemia forcoronary artery, which will increase the cost of operation and may cause additional risks. Quantitative flow ratio (QFR) is a novel angiography-based method for deriving FFR without pressure wire or induction of hyperemia. In present, there still are poor data about QFR-guided revascularization on non-culprit vessels in patients with STEMI. The purpose of this study is to compare the clinical effects of QFR-guided with angiography-guided revascularization on non-culprit vessel in STEMI patients with multi-vessel lesions.

NCT ID: NCT04123197 Enrolling by invitation - Clinical trials for Myocardial Infarction

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

MIMS3
Start date: February 28, 2020
Phase: N/A
Study type: Interventional

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.