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| ID | Type | Description | Link |
|---|---|---|---|
| 07-16-06E | Other Identifier | Atrium |
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The overall goal of this clinical research study is to prospectively assess primary outcomes related to pulmonary embolism (PE) that occur immediately (within 5 days) and within 30 days. The secondary goal is to compare validated prediction models and a modified European Society of Cardiology (ESC) approach that is primarily right ventricle dysfunction (RVD) driven with clinical risk assessment being secondary, and with primary outcomes of clinical deterioration within 5 days.
The investigators wish to develop the Pulmonary Embolism Short-term Clinical Outcomes Registry (PE-SCOR). The investigators also wish to determine the incidence of death and circulatory and respiratory deterioration, and administration of reperfusion therapy within 5 days in PE patients. The study will also evaluate the sensitivity, specificity and positive and negative predictive values of each RVD assessment option. The investigators will also derive a prediction model for PE patients for the primary outcome within five days. Finally, investigators will determine the functional outcomes of PE patients 30 days after PE.
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical Deterioration | Presence of any one clinical deterioration variable: death, circulatory or respiratory dysfunction, reperfusion interventions. | 5 days |
| Right ventricular dysfunction (RVD) | Presence of any one indicator of RVD: any one goal directed echocardiography finding of RVD (right ventricle (RV) enlargement or, leftward deviation of the interventricular septum, or RV systolic dysfunction by longitudinal movement of the tricuspid annulus of the RV free wall), CT right ventricle : left ventricle ratio greater or equal to 1, positive troponin or B-type Natriuretic Peptide, EKG injury and ischemia patterns of RVD | Index visit |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Outcome | Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire | 30 days |
| Pulmonary Embolism Complications | Presence of any one variable: recurrence of pulmonary embolism, subsequent hospitalizations, major and minor bleeding |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who present to the Emergency Department (ED) with image confirmed acute pulmonary embolism diagnosed within 12 hours of presentation.
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Weekes, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego Medical Center | San Diego | California | 92120 | United States | ||
| Christiana Care Health System |
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| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
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| 30 days |
| Newark |
| Delaware |
| 19718 |
| United States |
| Orlando Regional Medical Center | Orlando | Florida | 32806 | United States |
| Carolinas Healthcare System | Charlotte | North Carolina | 28203 | United States |
| Vanderbilt Medical Center | Nashville | Tennessee | 37232 | United States |
| University of Utah Hospital | Salt Lake City | Utah | 84132 | United States |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |