Pulmonary Embolism Clinical Trial
Official title:
Short-term Clinical Deterioration After Acute Pulmonary Embolism
Verified date | July 2019 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is a prospective, observational, multicenter cohort study to compare right ventricular dysfunction dependent and independent prognostic models for short-term serous adverse events in patients who are diagnosed with pulmonary embolism in the emergency department. Clinical endpoints are assessed at days 1-5. A thirty-day follow-up phone call is conducted to obtain further clinical endpoints and a quality of life assessment.
Status | Completed |
Enrollment | 935 |
Est. completion date | November 30, 2020 |
Est. primary completion date | November 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Men and women, 18 years or older, with image confirmed acute pulmonary embolism diagnosed within 12 hours of ED presentation Exclusion Criteria: - Patients who decline any participation in the study - Patients 17 years old and younger at the time of screening - Radiologist's over read that determines that filling defects identified as acute emboli are instead either chronic, resolving, or unchanged after comparison to previous CT, if available - If empiric anticoagulation or escalated intervention were initiated more than 12 hours before presentation to the recruiting ED - Identification of either segmental or subsegmental intraluminal filling defects on CT that are considered to be clinically incidental and unrelated to primary diagnostic workup or ED presentation. |
Country | Name | City | State |
---|---|---|---|
United States | Carolinas Medical Center - Main | Charlotte | North Carolina |
United States | Vanderbilt Medical Center | Nashville | Tennessee |
United States | Christiana Care Health System | Newark | Delaware |
United States | Orlando Regional Medical Center | Orlando | Florida |
United States | Univeristy of Utah Hospital | Salt Lake City | Utah |
United States | San Diego Medical Center | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences | Agency for Healthcare Research and Quality (AHRQ) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Development of prediction model for clinical deterioration outcomes within 5 days of PE presentation to emergency department | Use of logistic regression analysis to determine predictors of clinical deteriortion a=within 5 days of acute PE presentation at emergency department | 5 days | |
Primary | Compare the risk ratio odds ratio of different PE risk stratification models for clinical Deterioration | Provide and compare the number and proportion of patients with both composite and individual outcome of death, circulatory deterioration, respiratory deterioration, administration of reperfusion therapy | Five days from diagnosis | |
Secondary | Compare the prognostic accuracy of different right ventricular dysfunction parameters for predefined clinical deterioration outcomes within 5 days | Comparison of different Right Ventricular Dysfunction Assessments for Clinical deterioration within 5 days of PE diagnosis | 5 days from diagnosis | |
Secondary | Comparison of Patient Reported Pulmonary Embolism Functional outcomes at 30 days after Pulmonary Embolism Diagnosis | Comparison of functional outcomes between patients with and without Right ventricular dysfunction at presentation with higher scores indicating worse outcomes THe Pulmonary Embolism Quality of Life Questionnaire has six dimension of questions. Dimension scores are transformed into to scale from 0-100 with higher scores associated with worse outcomes. | 30 days after PE diagnosis |
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