Quantitative 3-Dimensional Chest CT Vascular Reconstruction Before and After Anticoagulation for...
Pulmonary EmbolismDesign: U.S.-based, single-center, proof-of-concept study Brief Description: A standard clinical contrast-enhanced chest CT scan performed 48 hours after clinically-indicated standard anticoagulation will be compared with a standard clinically-indicated baseline contrast-enhanced chest CT scan using a previously-studied and previously-validated 3-dimensional reconstruction technique to assess changes in the pulmonary vasculature in patients with acute pulmonary embolism (PE). This previously-studied and previously-validated 3-dimensional reconstruction technique has been used to assess the response of the pulmonary vasculature to catheter-based fibrinolysis in acute PE as well as to assess the pulmonary vasculature in a number of chronic lung diseases. However, the pulmonary vascular response to standard anticoagulation for acute PE has not been assessed previously. Purpose: To compare the pulmonary vasculature before and after standard clinically-indicated anticoagulation for acute PE using a previously-studied and previously-validated 3-dimensional reconstruction technique applied with a standard clinically-indicated baseline contrast-enhanced chest CT scan (used to diagnose the acute PE) and a standard clinical contrast-enhanced chest CT scan performed 48 hours later as indicated by the study protocol. Population: Inpatients diagnosed with acute PE, in whom clinical providers have prescribed standard anticoagulation alone for treatment based on clinical grounds at Brigham and Women's Hospital. Enrollment: 10 subjects with acute PE Clinical Site Location: Single-center, Brigham and Women's Hospital Study Duration: 12 months Primary Imaging Outcome: CT-determined percent change in perfusion of the pulmonary vasculature from baseline to 48 hours in inpatients diagnosed with acute PE, in whom clinical providers have prescribed standard anticoagulation alone for treatment based on clinical grounds at Brigham and Women's Hospital. Secondary Imaging Outcome: CT-determined percent change in right ventricular (RV) volume from baseline to 48 hours in inpatients diagnosed with acute PE, in whom clinical providers have prescribed standard anticoagulation alone for treatment based on clinical grounds at Brigham and Women's Hospital.
A Performance Evaluation of the LumiraDx Point Of Care D-dimer Assay
Deep Vein ThrombosisPulmonary Embolism1 moreIn patients with symptoms of Venous Thromboembolism (VTE) (mainly deep vein thrombosis (DVT) or pulmonary embolism (PE)), the study will evaluate the agreement between the D-Dimer measurements from the LumiraDx POC D-Dimer assay and a reference method, as an aid in diagnosis, assessment and exclusion of DVT and PE.
COVID-19 Registry to Assess Frequency, Risk Factors, Management, and Outcomes of Arterial and Venous...
Covid19Thrombosis Embolism4 moreNovel coronavirus 2019 (COVID-19) has emerged as a major international public health concern. While much of the morbidity and mortality associated with COVID-19 has been attributed to acute respiratory distress syndrome (ARDS) or end-organ failure, emerging data suggest that disorders of coagulation, in particular hypercoagulability and venous thromboembolism (VTE), may represent an additional major, and possibly preventable, complication (Wu C, et al. JAMA Intern Med. 2020 Mar 13. [Epub ahead of print] and Tang N, et al. Thromb. Haemost. 2020 Feb 19. [EPub Ahead of Print]). Abnormal coagulation testing results, especially markedly elevated D-dimer and FDP, have been associated with a poor prognosis in COVID-19 infection. We propose the following Electronic Health Record (EHR)-guided 10000-patient, retrospective observational cohort study to assess VTE incidence, risk factors, prevention and management patterns, and thrombotic outcomes in patients with COVID-19 infection. In order to gain the valuable perspective of other regional and national centers providing care for large populations of COVID-19, we have started a collaborative network with 5 additional sites which will provide us with de-identified data from 1000 patients each. These 5000 patients in addition to the 5000-patient cohort we are enrolling within the Mass General Brigham Network will comprise this study population.
Prevalence and Risk Factors of Chronic Thrombo-embolic Disease After a Pulmonary Embolism Event...
Chronic EmboilismVenous thromboembolic disease (VTE) is a common clinical entity whose two manifestations are deep vein thrombosis (DVT) and pulmonary embolism (PE). After an acute PE, almost half of the patients complain residual dyspnea, despite well-conducted curative anticoagulation. Some will present persistent defects on lung scan-scintigraphy, without pulmonary hypertension. This condition defines Chronic-Thrombo-Embolic Disease(CTED). The prevalence of CTED after PE is poorly known as are its risk factors. The primary objective is to determine the prevalence of CTED at 3 or 6 months, depending on the provoked or unprovoked character, after a PE. The secondary objectives are: To determine the potential risk factors for the occurrence of CTED. To look for an association between the persistence of DVT and the occurrence of CTED. To look for an association between the diagnosis of CTED and PE recurrence during the 12-month follow-up. To determine the diagnostic performance of the clinician alone compared to the lung scintigraphy (gold standard) for the diagnosis of CTED. To compare the impact on the quality of life (QoL) with or without CTED. To determine the correlation between impaired QoL and the degree of residual obstruction on lung scintigraphy.
Ventilation and Perfusion Scan in Pulmonary Embolism Following Catheter Directed Thrombectomy Versus...
Pulmonary EmbolismPulmonary Hypertension1 moreClinical presentation of acute pulmonary embolism (PE) is complex and varied and not uncommonly involves respiratory failure with dyspnea or hypoxia. Patients with persisting signs of respiratory failure despite anticoagulation, may benefit from catheter directed thrombectomy. Additionally, patient who receive thrombectomy are likely to have a lower residual thrombus burden measurable by ventilation-perfusion (V/Q) scan, and thereby less likely to develop chronic sequela, including chronic thromboembolic pulmonary hypertension (CTEPH) and post PE syndrome.
Six Years of Follow-up After Idiopathic Venous Throbmoembolism
Pulmonary EmbolismProximal Deep Vein ThrombosisBeyond the first 6 months of anticoagulation, patients with a first episode of unprovoked venous thromboembolism have a high risk of recurrence after stopping anticoagulations. Extending anticoagulant therapy for an additional 18 months is associated with a major reduction of recurrent VTE; however this benefit tended to be lost after stopping anticoagulation during a follow-up period of two years. This risk of recurrentce is likely to continuously increase over the years as well as the risk of chronic thromboembolic pulmonary hypertension (after pulmonary embolism) or the risk of post-thrombotic syndrome (after deep vein thrombosis). The aim of the PADIS-EXTENSION trial is to estimate these risks over 6 years of follow-up in patients who have been initially treated during 6 months or 24 months (patients included in the PADIS PE and PADIS DVT trial).
Pulmonary Embolism WArsaw REgistry
Acute Pulmonary EmbolismInitiated in January 2008, The PE-aWARE (Pulmonary Embolism WArsaw REgistry) is an on-going single-centre prospective observational study of patients with confirmed acute pulmonary embolism (APE). Extensive data on consecutive patients with pulmonary embolism is collected and stored. The main objective is to collect and provide information on patients' characteristics, management, and outcome with the purpose of decreasing mortality in APE, the occurrence of bleeding, and the frequency of thromboembolic recurrences. Moreover, the PE-aWARE registry serves as a basis for creating predictive scores for clinicians which aid patient management. The study endpoints comprise clinically recognized (and objectively confirmed) recurrences of PE, major and minor bleeding complications classified according to the International Society on Thrombosis and Haemostasis classification, need for cardiopulmonary resuscitation or catecholamines, and death.
Prognostic Tools in Patients With Acute Pulmonary Thromboembolism.
Pulmonary EmbolismAcute pulmonary embolism (PE) is a serious disease associated with high mortality rates despite advanced therapeutic options. The treatment options depend on the severity of the disease and the short - term mortality varies widely from 2 to 95%, depending on the severity of the condition
Registry of Patients Prescribed Anticoagulation
Acute Deep Vein ThrombosisAcute Pulmonary EmbolismThe Gonda Vascular Center- Thrombophilia Clinic at Mayo Clinic in Rochester, Minnesota utilizes a standardized, guideline-directed, yet patient-oriented approach for treating patients diagnosed with venous thromboembolism (VTE).This study is the ongoing registry of clinical practice with standardized approach to patient assessment and therapy. As most of registries it does not have any definite number of recruited subjects or the date of study completion but provides anticipated number of recruited subjects and the time of anticipated enrolment which was provided only because of formal requirement related to structure of ClinicalTrials.gov website. This number will be updated and upgraded as we continue this registry. The rates of VTE recurrence, major bleeding, clinically relevant non-major bleeding (CRNMB) and survival in patients treated with anticoagulation for acute VTE are assessed during prospective observation. VTE cases include an acute deep vein thrombosis (DVT) of lower or upper extremities, splanchnic veins, gonadal, renal, cerebral veins thrombosis and pulmonary embolism (PE). Therapy includes the whole spectrum of FDA approved anticoagulants such as "classic" agents: warfarin and heparinoids and the newer direct oral anticoagulants (DOACs) such as rivaroxaban, dabigatran, apixaban, and edoxaban.
Acutelines: a Large Data-/Biobank of Acute and Emergency Medicine
Acute DiseaseSepsis17 moreResearch in acute care faces many challenges, including enrollment challenges, legal limitations in data sharing, limited funding, and lack of singular ownership of the domain of acute care. To overcome some of these challenges, the Center of Acute Care of the University Medical Center Groningen in the Netherlands, has established a de novo data-, image- and biobank named "Acutelines". Acutelines is initiated to improve recognition and treatment of acute diseases and obtain insight in the consequences of acute diseases, including factors predicting its outcome. Thereby, Acutelines contributes to development of personalized treatment and improves prediction of patient outcomes after an acute admission.