Short-term Clinical Deterioration After Acute Pulmonary Embolism

Completed

• Conditions: Pulmonary Embolism

• Registration Number: NCT03915925
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

Detailed Description

The objective of this study is to compare right ventricular dysfunction (RVD)dependent and independent prognostic models for short-term serious adverse events in pulmonary embolism (PE) patients. The target population is emergency department (ED) patients with confirmed acute PE within 12 hours of ED presentation. The primary outcome is a composite of death, delayed circulatory or respiratory dysfunction, hypoxia, and reperfusion intervention within five days of PE diagnosis. Secondary outcomes will be nonfatal bleeding, recurrence of venous thromboembolism, and hypoxia requiring oxygen supplementation.

The specific aims are: 1) determine the incidence of death, circulatory and respiratory deterioration, and administration of reperfusion therapy within five days of PE; 2) determine functional outcomes 30 days after PE using the Pulmonary Embolism Quality of Life Questionnaire; 3) evaluate the sensitivity, specificity, and positive and negative likelihood ratios of each RVD assessment tool for clinical deterioration within five days of PE; and 4) derive a prediction model for clinical deterioration within five days of PE diagnosis.

Patients with confirmed PE will be assessed for hemodynamic stability at presentation, and then will be assessed for RVD. Normotensive PE patients without RVD will be assessed by a clinically derived model (sPESI or HESTIA) to determine if they are low risk or intermediate-low risk. The investigators will then determine incidence of the clinical endpoints during the subsequent 5 days, as well as 30 days later. The 30-day follow-up will also include administration of the validated Pulmonary Embolism Quality of Life questionnaire (PEmbQoL).

Study Timeline

• Study Start: 2018-09-30
• Study First Submitted: 2019-04-12
• Study First Submitted QC: 2019-04-15
• Study First Posted: 2019-04-16
• Status Verified: 2019-07
• Primary Completion: 2020-11-30
• Study Completion: 2020-11-30
• Last Update Submitted: 2022-04-20
• Last Update Posted: 2022-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 935

Inclusion Criteria

• Men and women, 18 years or older, with image confirmed acute pulmonary embolism diagnosed within 12 hours of ED presentation

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compare the risk ratio odds ratio of different PE risk stratification models for clinical Deterioration	Five days from diagnosis	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

Secondary Outcome Measures

Name	Time	Method
Compare the prognostic accuracy of different right ventricular dysfunction parameters for predefined clinical deterioration outcomes within 5 days	5 days from diagnosis	Comparison of different Right Ventricular Dysfunction Assessments for Clinical deterioration within 5 days of PE diagnosis
Comparison of Patient Reported Pulmonary Embolism Functional outcomes at 30 days after Pulmonary Embolism Diagnosis	30 days after PE 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.

Trial Locations

Locations (6)

San Diego Medical Center; 🇺🇸 San Diego, California, United States

Orlando Regional Medical Center; 🇺🇸 Orlando, Florida, United States

Carolinas Medical Center - Main; 🇺🇸 Charlotte, North Carolina, United States

Vanderbilt Medical Center; 🇺🇸 Nashville, Tennessee, United States

Univeristy of Utah Hospital; 🇺🇸 Salt Lake City, Utah, United States

Christiana Care Health System; 🇺🇸 Newark, Delaware, United States