Pulmonary Embolism Clinical Trial
— PE-SCOROfficial title:
Pulmonary Embolism Short-term Clinical Outcomes Registry (PE-SCOR)
Verified date | January 2020 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The overall goal of this clinical research study is to prospectively assess primary outcomes related to pulmonary embolism (PE) that occur immediately (within 5 days) and within 30 days. The secondary goal is to compare validated prediction models and a modified European Society of Cardiology (ESC) approach that is primarily right ventricle dysfunction (RVD) driven with clinical risk assessment being secondary, and with primary outcomes of clinical deterioration within 5 days.
Status | Completed |
Enrollment | 815 |
Est. completion date | February 20, 2019 |
Est. primary completion date | February 20, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients 18 years or older with image confirmed acute pulmonary embolism diagnosed within 12 hours of ED presentation will be eligible for enrollment. Exclusion Criteria: - Patients who refuse consent for 30-day clinical contact and follow-up. |
Country | Name | City | State |
---|---|---|---|
United States | Carolinas Healthcare System | 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 | University of Utah Hospital | Salt Lake City | Utah |
United States | San Diego Medical Center | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical Deterioration | Presence of any one clinical deterioration variable: death, circulatory or respiratory dysfunction, reperfusion interventions. | 5 days | |
Primary | Right ventricular dysfunction (RVD) | Presence of any one indicator of RVD: any one goal directed echocardiography finding of RVD (right ventricle (RV) enlargement or, leftward deviation of the interventricular septum, or RV systolic dysfunction by longitudinal movement of the tricuspid annulus of the RV free wall), CT right ventricle : left ventricle ratio greater or equal to 1, positive troponin or B-type Natriuretic Peptide, EKG injury and ischemia patterns of RVD | Index visit | |
Secondary | Functional Outcome | Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire | 30 days | |
Secondary | Pulmonary Embolism Complications | Presence of any one variable: recurrence of pulmonary embolism, subsequent hospitalizations, major and minor bleeding | 30 days |
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