Clinical trial NCT03915925: Short-term Clinical Deterioration After Acute Pulmonary Embolism
Official title: Short-term Clinical Deterioration After Acute Pulmonary Embolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Embolism
Keywords: right ventricle dysfunction
prediction model
functional outcomes
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2019-04-16
Enrollment: 935
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Compare the risk ratio odds ratio of different PE risk stratification models for clinical Deterioration
timeFrame: Five days from diagnosis
Secondary outcomes:
measure: Compare the prognostic accuracy of different right ventricular dysfunction parameters for predefined clinical deterioration outcomes within 5 days
timeFrame: 5 days from diagnosis
measure: Comparison of Patient Reported Pulmonary Embolism Functional outcomes at 30 days after Pulmonary Embolism Diagnosis
timeFrame: 30 days after PE diagnosis
Other outcomes:
measure: Development of prediction model for clinical deterioration outcomes within 5 days of PE presentation to emergency department
timeFrame: 5 days
Locations:
city: San Diego
country: United States
facility: San Diego Medical Center
state: California
city: Newark
country: United States
facility: Christiana Care Health System
state: Delaware
city: Orlando
country: United States
facility: Orlando Regional Medical Center
state: Florida
city: Charlotte
country: United States
facility: Carolinas Medical Center - Main
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt Medical Center
state: Tennessee
city: Salt Lake City
country: United States
facility: Univeristy of Utah Hospital
state: Utah
Study officials:
affiliation: Wake Forest University Health Sciences
name: Anthony Weekes, MD
role: PRINCIPAL_INVESTIGATOR
References: