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Short-term Clinical Deterioration After Acute Pulmonary Embolism

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ClinicalTrials.gov Identifier: NCT03915925
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Anthony Weekes, Atrium Health

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.

Condition or disease
Pulmonary Embolism

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).


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Study Type : Observational
Estimated Enrollment : 880 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Short-term Clinical Deterioration After Acute Pulmonary Embolism
Actual Study Start Date : September 30, 2018
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Clinical Deterioration [ Time Frame: Five days from diagnosis ]
    Composite outcome of death, circulatory deterioration, respiratory deterioration, administration of reperfusion therapy


Secondary Outcome Measures :
  1. Functional outcome [ Time Frame: 30-days from diagnosis ]
    Pulmonary Embolism Quality of Life Questionnaire

  2. Readmission [ Time Frame: 30-days from diagnosis ]
    Readmissions for reasons related to PE, including recurrence

  3. Bleeding complications [ Time Frame: 30-days from diagnosis ]
    Episodes of major or minor bleeding

  4. Death [ Time Frame: 30-days from diagnosis ]
    Death from all causes



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915925


Contacts
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Contact: Anthony Weekes, MD 704-355-3181 anthony.weekes@atriumhealth.org
Contact: Melanie Hogg, BS 704-355-4288 melanie.hogg@atriumhealth.org

Locations
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United States, California
San Diego Medical Center Recruiting
San Diego, California, United States, 92120
Principal Investigator: Dasia Esener, MD         
United States, Delaware
Christiana Care Health System Recruiting
Newark, Delaware, United States, 19718
Principal Investigator: Jason Nomura, MD         
United States, Florida
Orlando Regional Medical Center Recruiting
Orlando, Florida, United States, 32806
Principal Investigator: Steve Leech, MD         
United States, North Carolina
Carolinas Medical Center - Main Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Melanie Hogg, BS    704-355-4288    melanie.hogg@atriumhealth.org   
Principal Investigator: Anthony Weekes, MD         
United States, Tennessee
Vanderbilt Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Principal Investigator: Jeremy Boyd, MD         
United States, Utah
Univeristy of Utah Hospital Recruiting
Salt Lake City, Utah, United States, 84132
Principal Investigator: Patrick Ockerse, MD         
Sponsors and Collaborators
Atrium Health
Agency for Healthcare Research and Quality (AHRQ)
Investigators
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Principal Investigator: Anthony Weekes, MD Atrium Health

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Responsible Party: Anthony Weekes, Professor of Emergency Medicine, Atrium Health
ClinicalTrials.gov Identifier: NCT03915925     History of Changes
Other Study ID Numbers: 1R01HS025979 ( U.S. AHRQ Grant/Contract )
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anthony Weekes, Atrium Health:
right ventricle dysfunction
prediction model
functional outcomes

Additional relevant MeSH terms:
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Embolism
Pulmonary Embolism
Clinical Deterioration
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Disease Progression
Disease Attributes
Pathologic Processes