Pulmonary EmbolismPE-SCORNCT02883491
Pulmonary Embolism Short-term Clinical Outcomes Registry
An observational study of Pulmonary Embolism, run by Wake Forest University Health Sciences at 6 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- How many people
- 815 participants
- Where
- 6 sitesUnited States
- Study dates
- Aug 2016to 20 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who present to the Emergency Department (ED) with image confirmed acute pulmonary embolism diagnosed within 12 hours of presentation.
Who may be able to join
- Patients 18 years or older with image confirmed acute pulmonary embolism diagnosed within 12 hours of ED presentation will be eligible for enrollment.
Who cannot join
- Patients who refuse consent for 30-day clinical contact and follow-up.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Carolinas Healthcare System
Charlotte, North Carolina, 28203
Vanderbilt Medical Center
Nashville, Tennessee, 37232
Christiana Care Health System
Newark, Delaware, 19718
Orlando Regional Medical Center
Orlando, Florida, 32806
University of Utah Hospital
Salt Lake City, Utah, 84132
San Diego Medical Center
San Diego, California, 92120
About this study
Official title: Pulmonary Embolism Short-term Clinical Outcomes Registry (PE-SCOR)
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.
Read the detailed description
The investigators wish to develop the Pulmonary Embolism Short-term Clinical Outcomes Registry (PE-SCOR). The investigators also wish to determine the incidence of death and circulatory and respiratory deterioration, and administration of reperfusion therapy within 5 days in PE patients. The study will also evaluate the sensitivity, specificity and positive and negative predictive values of each RVD assessment option. The investigators will also derive a prediction model for PE patients for the primary outcome within five days. Finally, investigators will determine the functional outcomes of PE patients 30 days after PE.
- Conditions
- Pulmonary Embolism
- Medical subject headings
- Pulmonary Embolism
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Deterioration
Presence of any one clinical deterioration variable: death, circulatory or respiratory dysfunction, reperfusion interventions.
Measured: 5 days
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
Measured: Index visit
Secondary outcomes (2)
Functional Outcome
Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire
Measured: 30 days
Pulmonary Embolism Complications
Presence of any one variable: recurrence of pulmonary embolism, subsequent hospitalizations, major and minor bleeding
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startAug 2016
- Primary completion20 Feb 2019
- Study completion20 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 815 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony Weekes, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883491
- Sponsor's protocol ID
- IRB00082655
- Other IDs
- 07-16-06E
- Acronym
- PE-SCOR
- Status last verified
- Jan 2020
- First submitted
- 19 Aug 2016
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Embolism Short-term Clinical Outcomes Registry (PE-SCOR)
- ClinicalTrials.gov ID
- NCT02883491
- Acronym / sponsor ID
- PE-SCOR / IRB00082655
- Conditions
- Pulmonary Embolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 815 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- 20 Feb 2019 (actual)
- Study completion
- 20 Feb 2019 (actual)
- First posted
- 30 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators wish to develop the Pulmonary Embolism Short-term Clinical Outcomes Registry (PE-SCOR). The investigators also wish to determine the incidence of death and circulatory and respiratory deterioration, and administration of reperfusion therapy within 5 days in PE patients. The study will also evaluate the sensitivity, specificity and positive and negative predictive values of each RVD assessment option. The investigators will also derive a prediction model for PE patients for the primary outcome within five days. Finally, investigators will determine the functional outcomes of PE patients 30 days after PE.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who present to the Emergency Department (ED) with image confirmed acute pulmonary embolism diagnosed within 12 hours of presentation.
Key inclusion criteria (1 listed)
- Patients 18 years or older with image confirmed acute pulmonary embolism diagnosed within 12 hours of ED presentation will be eligible for enrollment.
Key exclusion criteria (1 listed)
- Patients who refuse consent for 30-day clinical contact and follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical Deterioration
Time frame: 5 days
Presence of any one clinical deterioration variable: death, circulatory or respiratory dysfunction, reperfusion interventions.
Right ventricular dysfunction (RVD)
Time frame: Index visit
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
2 secondary outcomes
Functional Outcome
Time frame: 30 days
Pulmonary Embolism Complications
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Weekes, MD principal investigator
Wake Forest University Health Sciences
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism, run by Wake Forest University Health Sciences at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Deterioration (time frame: 5 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.