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Pulmonary Embolism clinical trials

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NCT ID: NCT06043726 Recruiting - Pulmonary Embolism Clinical Trials

Diagnostic Accuracy of Arterial-alveolar Oxygen Gradient in Low Risk Patients With Suspected Pulmonary Embolism

DAGPE
Start date: September 1, 2022
Phase:
Study type: Observational

Introduction: The diagnosis of pulmonary embolism (PE) is a challenge in the Emergency Department. D-dimer based diagnostic algorithms for PE have a very high sensitivity, but rely upon a vast amount of CT angiography and potentially unnecessary exposure to radiation. An accurate diagnostic algorithm that does not involve d-dimer testing might reduce this burden. An abnormal Alveolar-arterial oxygen gradient (A-a gradient) seems to increase the chance of PE. However, a normal A-a gradient on its own does not exclude the diagnosis. In this paper, the accuracy of A-a gradient testing and a combination of Years criteria with A-a gradient testing will be assessed. Methods: This is a prospective, single center, observational study. All patients that present at our emergency department from September 2022 until September 2023 with a suspicion of pulmonary embolism will be analyzed for eligibility and included in the study after informed consent. The aim is to include at least 230 patients in the study. Analysis: The primary outcome is the diagnostic accuracy of a YEARS and A-a gradient based algorithm for pulmonary embolism. The secondary outcome is the potential decrease in performed imaging in order to exclude pulmonary embolism. Valorisation An accurate A-a gradient-based algorithm for pulmonary embolism in low risk patients will be a step towards an improved clinical risk score. We aim to reduce the amount of diagnostic imaging, i.e. CT-angiography. Meaning less, potentially unnecessary, exposure to radiation for the patient. Furthermore, it could lower healthcare costs by reducing expensive diagnostic imaging.

NCT ID: NCT06038630 Recruiting - Anemia Clinical Trials

129Xe MRI Cardiopulmonary

Start date: January 12, 2024
Phase: Phase 2
Study type: Interventional

The goal of this NIH-sponsored study is to characterize three biomarkers derived from 129Xe gas exchange MRI and to understand how they change in response to interventions.

NCT ID: NCT06037096 Recruiting - Pulmonary Embolism Clinical Trials

Implementation of a Structured Post-pulmonary Embolism Follow-up Model

Start date: March 15, 2022
Phase: N/A
Study type: Interventional

Venous thromboembolism (VTE), clinically presenting as deep vein thrombosis or pulmonary embolism (PE) is the third most common cardiovascular disease and is associated with substantial short- and long-term morbidity and mortality and high costs of care. In addition negative physical and mental complications following VTE are common. However in terms of PE, there are no structured follow-up programs in Denmark and there is considerable variation in practice patterns of post-PE management both within and between countries. The Attend-PE project aims to develop, test and implement a structured follow-up model in a hospital setting for patients with pulmonary embolism. The Attend-PE is a pre-post intervention study and will estimate the effectiveness of implementing the structured care model on a national level.

NCT ID: NCT06015529 Recruiting - Pulmonary Embolism Clinical Trials

Diagnostic Strategy for Suspected Pulmonary Embolism Based on 4PEPS

SPEED&PEPS
Start date: November 29, 2023
Phase: N/A
Study type: Interventional

The increased use of diagnostic imaging and especially computed tomography pulmonary angiography in patients suspected of pulmonary embolism (PE) is an important point of concerns. The goal of this pragmatic cluster-randomized trial is to compare the diagnostic strategy based on the four-level pulmonary embolism probability score (4PEPS) and current practices. The main questions it aims to answer is: "Does the diagnostic strategy based on 4PEPS significantly reduce the use of thoracic imaging without increasing the risk of serious adverse events as compared to current diagnostic practices?" Patients suspected of having PE in the participating emergency departments will be included and followed for 90 days. In ten centers, the emergency physicians will apply the 4PEPS strategy and in ten other centers, the emergency physicians will be free to do as they see fit. Researchers will compare the two groups of patients to see if the rate of diagnostic thoracic imaging tests and the rate of adverse events related to diagnostic strategies will differ.

NCT ID: NCT05907564 Recruiting - Clinical trials for Cardiovascular Diseases

Aventus Thrombectomy System Pulmonary Embolism Clinical Study

Start date: September 20, 2023
Phase: N/A
Study type: Interventional

Evaluate the safety and efficacy of the Aventus Thrombectomy System for aspiration thrombectomy in subjects with acute pulmonary embolism.

NCT ID: NCT05905874 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Machine Learning-based Models in Prediction of DVT and PTE in AECOPD Patients

Start date: January 1, 2023
Phase:
Study type: Observational

Chronic Obstructive Pulmonary Disease (COPD) is a common respiratory system disease characterized by persistent respiratory symptoms and irreversible airflow restriction, which seriously endangers people's health. Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) refers to individuals who experience continuous deterioration beyond their daily condition and need to change their routine medication. AECOPD is usually caused by viruses and bacteria, and patients require hospitalization, which brings a huge economic burden to society. AECOPD patients often have limited activities. Because long-term chronic hypoxia causes venous blood stasis, siltation causes secondary red blood cell increase, and blood hypercoagulability, AECOPD patients have a high risk of pulmonary embolism (PE). Pulmonary Thrombo Embolism (PTE) refers to a disease caused by blockage of the pulmonary artery or its branches caused by a thrombus from the venous system or right heart. AECOPD patients experience elevated hemoglobin levels and increased blood viscosity due to long-term hypoxia. At the same time, such patients have decreased activity, venous congestion, and are prone to thrombosis. After the thrombus falls off, it can travel up the vein, causing PTE to occur in the right heart PTE is often secondary to low deep vein thrombosis (DVT). About 70% of patients were diagnosed as deep vein thrombosis in lower limb color ultrasound examination. SteinPD conducted a survey on COPD patients and general patients from multiple hospitals. The results showed that by comparing adult COPD patients with non COPD patients, the relative risk of DVT was 1.30, providing evidence for AECOPD being more likely to combine with PTE AECOPD patients with PTE have similarities in their clinical manifestations. It is difficult to distinguish between the two based solely on symptoms, such as cough, increased sputum production, increased shortness of breath, and difficulty breathing. They lack specificity and are difficult to distinguish between the two based solely on symptoms, which can easily lead to missed diagnosis. CT pulmonary angiography (CTPA) is the gold standard for the diagnosis of PTE, but due to the high cost of testing and high equipment prices, its popularity in grassroots hospitals is not high. Therefore, analyzing the risk factors of AECOPD patients complicated with PTE is of great significance for early identification of PTE. At present, although there are reports on the risk factors for concurrent PTE in AECOPD patients, there is no specific predictive model for predicting PTE in AECOPD patients. In clinical practice, risk assessment tools such as the Caprini risk assessment model and the modified Geneva scale are commonly used for VTE, while the Wells score is the PTE diagnostic likelihood score. The evaluation indicators of these tools are mostly clinical symptoms, and laboratory indicators are less involved, It is difficult to comprehensively reflect the patient's condition, so the specificity of AECOPD patients with PTE is not strong. The column chart model established in this study presents a visual prediction model, which is convenient for clinical use and has positive help for the early detection of AECOPD patients with PTE. In addition, medical staff can present the calculation results of the column chart model to patients, making it easier for patients to understand. It helps improve the early identification and treatment of AECOPD combined with PTE patients, thereby improving prognosis.

NCT ID: NCT05891886 Recruiting - Pulmonary Embolism Clinical Trials

Supplemental Oxygen in Pulmonary Embolism (SO-PE)

SO-PE
Start date: October 1, 2023
Phase: Early Phase 1
Study type: Interventional

A study of how supplemental oxygen helps patients with acute pulmonary embolism (PE). Hypothesis: Oxygen affects right ventricular dysfunction (RVD) in patients with acute pulmonary embolism (PE) primarily by relieving hypoxic pulmonary vasoconstriction and reducing pulmonary pressure (PA) pressure, and that this process is metabolically driven.

NCT ID: NCT05855317 Recruiting - Clinical trials for Acute Respiratory Distress Syndrome

Association Between the Level of EV-TF and the Occurence of Pulmonary Embolism in Patients With ARDS

THROMBO-EVTF
Start date: October 31, 2023
Phase:
Study type: Observational

In this study, 120 patients with Acute Respiratory Distress Syndrome (ARDS) will be included on a two years-period in an intensive care unit (Assistance Publique des Hôpitaux de Marseille, France). Those patients will benefit from a blood test at inclusion in order to measure several coagulation biomarkers, including EV-TF. Subsequently, these patients will be treated according to the usual practices of the department, following recommendations. Patients who received an injected CT scan between Day 5 and Day 28 will be divided into two groups based on the presence or absence of a pulmonary embolism on imaging. The measured values of EV-TF levels and other studied biomarkers will be compared between these two groups in order to detect a possible association between them and the diagnosis of pulmonary embolism. It should be noted that patients receiving an injected CT-scan between Day 5 and Day 7 will be included in the main analysis while those receiving it between Day 8 and Day 28 will be included in the secondary analysis. Others will be excluded from any analysis. At the same time, several collections of clinical data will be carried out: on Day 1, Day 7, Day 28, and on the day of the CT scan if it is performed at another time.

NCT ID: NCT05852119 Recruiting - Clinical trials for Acute Pulmonary Embolism

Prospective Study for the Outpatient Treatment of Patients With Very Low Risk Acute Symptomatic Pulmonary Embolism.

TRAMTEP
Start date: April 10, 2023
Phase: N/A
Study type: Interventional

Objectives: To evaluate the safety of outpatient treatment of patients with very low-risk pulmonary embolism (PE), and the satisfaction and quality of life of this management. Methods: An experimental study of routine clinical practice will be carried out in which 300 consecutive hemodynamically stable patients with acute symptomatic PE will be included, who meet all the inclusion criteria and none of the exclusion criteria. All patients included in the study will be treated on an outpatient basis, that is, they will be discharged within the first 24 hours of the diagnosis of PE in the Emergency Department. The Computerized Registry of Thromboembolic Disease RIETE (Registro Informatizado de Enfermedad TromboEmbólica) will be used to collect the data in electronic case report form (CRF) and ensure the quality of the data. Setting: Emergency, Pneumology and Internal Medicine Services of 10 Spanish hospitals. Analysis: An intention-to-treat (ITT) analysis will be performed on all patients who sign the informed consent and are included in the study (regardless of whether or not they receive the assigned strategy). Additionally, an analysis of all patients who are treated on an outpatient basis without deviations or violations of the protocol will be performed. The primary outcome considered will be the composite of recurrent PE, major bleeding, or death from any cause during the first 30 days after enrollment in the study. Patient satisfaction and quality of life will be considered as secondary outcomes.

NCT ID: NCT05785676 Recruiting - Pulmonary Embolism Clinical Trials

ALN OATF Vena Cava Filter

CONFIAL
Start date: February 14, 2023
Phase:
Study type: Observational

Migration of a thrombus in the pulmonary circulation is the leading cause of pulmonary embolism (PE). It can be prevented mechanically by implanting a vena cava filter (VCF) in the inferior vena cava. The implation of a VCF is indicated for patients with acute PE and a contraindication to anticoagulation, with an acute deep vein thrombosis (DVT) without PE and a contraindication to anticoagulation or with acute venous thromboembolism (less than 3 months) in whom an interventional gesture at hemorrhagic and thromboembolic risk contraindicates anticoagulation. The purpose of this study is to describe the rates of implantation, removal and complications associated with the use of the optional ALN OATF VCF in current practice.