Short-term Clinical Deterioration After Acute Pulmonary Embolism

NCT03915925 | Completed

• 1 other identifier: 1R01HS025979
• Study Type: observational
• Target: 935
• Locations: 1 country
• Sites: 6

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.

Conditions

Pulmonary Embolism

Keywords

right ventricle dysfunction; prediction model; functional outcomes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Compare the prognostic accuracy of different right ventricular dysfunction parameters for predefined clinical deterioration outcomes within 5 days

  5 days from diagnosis

• Comparison of Patient Reported Pulmonary Embolism Functional outcomes at 30 days after Pulmonary Embolism Diagnosis

  30 days after PE diagnosis

Other Outcomes (1)

• Development of prediction model for clinical deterioration outcomes within 5 days of PE presentation to emergency department

  5 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who present to the emergency department with image confirmed acute pulmonary diagnosed within 12 hours of presentation

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (6)

San Diego Medical Center

San Diego, California, 92120, United States

Location

Christiana Care Health System

Newark, Delaware, 19718, United States

Location

Orlando Regional Medical Center

Orlando, Florida, 32806, United States

Location

Carolinas Medical Center - Main

Charlotte, North Carolina, 28203, United States

Location

Vanderbilt Medical Center

Nashville, Tennessee, 37232, United States

Location

Univeristy of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Anthony Weekes, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: April 16, 2019
• Study Start: September 30, 2018
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: April 27, 2022

Record last verified: 2019-07

Locations

US (6)