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Shock, Cardiogenic clinical trials

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NCT ID: NCT05415332 Recruiting - Cardiogenic Shock Clinical Trials

The Current Status and Clinical OUTcomes of Cardiogenic Shock Patients And the Role of Specialist in Cardiovascular Critical Care Unit

SCOUT SPARC
Start date: June 1, 2020
Phase:
Study type: Observational

In the case of cardiogenic shock, the early mortality rate is the highest compared to other types of shock, but it is characterized by a good prognosis and quality of life after recovery, so monitoring the treatment progress is very important to identify the patient's prognosis. However, there are few studies specifically reported on hemodynamic monitoring and prognosis of cardiogenic shock. In addition, as mechanical circulatory support devices are in the spotlight, studies on their effects and safety are starting, but studies on cardiogenic shock are often limited to patients with myocardial infarction. This study is a prospective and retrospective cohort observational study, we aim to identify factors that can improve prognosis, including various drug treatments, diagnostic techniques, and mechanical circulatory support device by investigating the treatment status and clinical outcomes of patients with cardiogenic shock hospitalized in cardiovascular critical care unit. In addition, the purpose of this study is to investigate the association between the prognosis of patients with cardiogenic shock and the presence of a specialist resident during regular work hours to clarify the role and necessity of a resident specialist in the cardiovascular intensive care unit. Furthermore, by predicting and treating the clinical course of patients with cardiogenic shock at an early stage, the aim is to reduce the mortality rate and improve the patients' ability to perform daily activities.

NCT ID: NCT05366452 Recruiting - Cardiogenic Shock Clinical Trials

Evaluation of the Efficacy of Early Implantation of a Percutaneous Left Ventricular Assist Devices in Acute Coronary Syndrome Complicated by Cardiogenic Shock Compared to Conventional Therapy: a Prospective, Multicenter, Randomized, Controlled and Open-label Clinical Trial

ULYSS
Start date: December 19, 2022
Phase: N/A
Study type: Interventional

The ULYSS study is a randomized, multicenter, interventional and prospective open-label clinical trial. It aims to evaluate the efficacy of the addition of an early IMPELLA CP support on top of optimal medical therapy and culprit lesion PCI compared to optimal medical care and culprit PCI in patients with an ACS complicated by a CS. A transthoracic echography is required to exclude some non-inclusion criteria as soon as possible and before randomization. Randomization will be performed after an informed consent is signed by the patient, a family member if he is unable to consent or thanks to the emergent consent procedure if all inclusion criteria are met and there are no non-inclusion criteria. A computer-generated randomization list will be drawn-up using a permuted block design (stratified on center). Each center will have a specific list. Randomization 1:1 to one of the 2 groups In all patients, emergent PCI of the culprit lesion will be performed. - Control group: patients will receive IV inotropes associated or not with vasopressors according to the attached protocol and based on the current guidelines (annex 1) (2, 4) in addition to emergent culprit lesion PCI - Experimental group: patients will receive IMPELLA CP before PCI on top of conventional therapy based on the same protocol as the control group and emergent culprit PCI

NCT ID: NCT05350592 Recruiting - Clinical trials for Acute Myocardial Infarction

Low-Dose Dobutamine and Single-Dose Tocilizumab in Acute Myocardial Infarction With High Risk of Cardiogenic Shock

DOBERMANN
Start date: March 7, 2022
Phase: Phase 2
Study type: Interventional

In the present study, we aim to investigate the effects of dobutamine infusion and/or a single intravenous (IV) dose of the IL-6 antagonist Tocilizumab administered after percutaneous coronary intervention (PCI) to patients with acute myocardial infarction (AMI) presenting < 24 hours from onset of chest pain and an intermediate to high risk of cardiogenic shock (CS) by assessment with the ORBI risk score (≥10 - not in overt shock at hospital admission). Plasma concentrations of pro-B-type natriuretic peptide (proBNP) as a proxy for development of cardiogenic shock (CS) and hemodynamic instability will be sampled for primary endpoint analysis. Effects on clinical parameters, mortality, morbidity as well as specific indicators of inflammation, cardiac function, and infarct size will secondarily be assessed noninvasively. The rationale behind the current study is that inflammatory and neurohormonal responses are associated with subclinical hemodynamic instability in patients with AMI with high risk of CS have worse outcomes. The potentially unstable condition may be targeted pharmacologically as an add-on to existing therapy. This is investigated in patients at elevated risk of CS by sampling biomarkers reflecting the inflammatory and neurohormonal responses, as well as determining effects on patient outcomes and infarct size.

NCT ID: NCT05298124 Recruiting - Clinical trials for Mitral Regurgitation

Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock

MINOS
Start date: May 26, 2022
Phase: N/A
Study type: Interventional

Mitral regurgitation may be seen in the setting of cardiogenic shock. Transcatheter edge-to-edge repair (TEER) has been shown to improve outcomes in patients with chronic heart failure. Observational studies suggest improvements in clinical outcomes in patients with mitral regurgitation in the setting of cardiogenic shock; however, there remains a lack of randomized clinical data to support the use of TEER in cardiogenic shock. This study will be a multicenter, open-label, randomized-controlled trial with two study arms: medical therapy and TEER. Patients admitted to the Cardiac Intensive Care Unit (CICU), Cardiac Surgery Intensive Care Unit (CSICU) or Intensive Care Units (ICU) at participating centers will be recruited. The study aims to answer the question: "Does TEER in patients with SCAI stage C or D cardiogenic with concomitant moderate or greater mitral regurgitation improve outcomes as compared to medical therapy?" The study hypothesis is that TEER will lead to an overall improvement in the composite outcome as compared to the medical therapy arm.

NCT ID: NCT05267886 Recruiting - Shock, Cardiogenic Clinical Trials

CAPITAL DOREMI 2: Inotrope Versus Placebo Therapy for Cardiogenic Shock

DOREMI-2
Start date: March 5, 2022
Phase: Phase 4
Study type: Interventional

The investigators are interested in determining if there is a meaningful benefit from the use of medications purported to increase the pumping function of the heart (i.e. inotropes) among critically ill patients admitted to the Cardiac Intensive Care Unit (CICU). To do this, the investigators will conduct a multi-centre, double blind, randomized control trial with patients who are deemed to require these medications by their treating physician to one of the two most commonly used agents in Canada (Milrinone or Dobutamine) or placebo. Each patient will be closely monitored by their healthcare team. The dose of medication will be adjusted according to each patients' clinical status. After 12 hours, the participants will move to open label treatment and any continued use of inotropes will be at the discretion of their treating physician.

NCT ID: NCT05246683 Recruiting - Clinical trials for Acute Coronary Syndrome

LATIN SHOCK: Latin American Registry of Cardiogenic Shock in the Context of Acute Coronary Syndrome

LATIN-SHOCK
Start date: February 15, 2022
Phase:
Study type: Observational [Patient Registry]

This is a Registry of the characteristics and clinical evolution of patients admitted for acute coronary syndromes (with or without st segment elevation) who present with cardiogenic shock or develop it during the hospitalization period. Cardiogenic shock is a rare pathology, but it constitutes the leading cause of mortality in patients hospitalized for acute infarction myocardium. Its incidence ranges between 7 and 10% of the cases of infarction1 and is associated with a mortality of 40-50% despite revascularization and the use of Intra-Aortic Counterpulsation Balloon. Most of the bibliography on this subject is North American and has a lot of years and the one currently published shows mostly the results of different ventricular supports that are not used routinely in our countries. So far there is no record that reports the reality of Latin America. Only in Argentina, a registry has been carried out (Re Na Shock) but more than 5 years have passed since its publication. In the last years have even changed the management guidelines for this pathology and have been published works that could have changed previous behaviors . This is a project of the Argentine Society of Cardiology to collect data epidemiological and current management of cardiogenic shock in Latin America.

NCT ID: NCT05185492 Recruiting - Clinical trials for Acute Myocardial Infarction

Multi-center Collaborative to Enhance Quality and Outcomes in the Management of Cardiogenic Shock

VANQUISH SHOCK
Start date: May 25, 2022
Phase:
Study type: Observational [Patient Registry]

This large real-world international prospective registry will provide a unique opportunity to comprehensively understand the contemporary management, clinical course and short as well as long-term outcomes of all Cardiogenic Shock (CS) patients cared for at four high volume dedicated shock care centers. As the first true North American multicenter CS collaborative with a uniform dedicated and comprehensive case report form, the high patient volumes and wide spectrum of clinical acuity seen at these institutions will provide valuable insight into the factors associated with adverse outcomes; and will serve as a blueprint for future clinical trial designs that may better inform clinical practice.

NCT ID: NCT05184296 Recruiting - Septic Shock Clinical Trials

ExtraCorporeal Membrane Oxygenation in the Therapy for REfractory Septic Shock With Cardiac Function Under Estimated

ECMO-RESCUE
Start date: May 1, 2023
Phase: N/A
Study type: Interventional

The ECMO-RESCUE study is a prospective, multicenter, non-randomized, cohort study. In this study, we aimed to assessed whether VA-ECMO treatment can improve the 30-day survival rate of patients with sepsis-induced refractory cardiogenic shock.

NCT ID: NCT05168462 Recruiting - Clinical trials for Myocardial Infarction

Clinical Outcome and Cost-effectiveness of Reduced Noradrenaline by Using a Lower Blood Pressure Target in Patients With Cardiogenic Shock From Acute Myocardial Infarction

NORSHOCK
Start date: October 1, 2022
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT05146336 Recruiting - Sepsis Clinical Trials

CytOSorb TreatMent Of Critically Ill PatientS Registry

COSMOS
Start date: June 22, 2022
Phase:
Study type: Observational [Patient Registry]

Registry intended to provide a data repository and reporting infrastructure for the surveillance of CytoSorb device use in real-world critical care settings, and to serve as an objective, comprehensive, and scientifically-based resource to measure and improve the quality of patient care