Pulmonary EmbolismNCT00562042
Risk Stratification for Patients Presenting With Acute Pulmonary Embolism (PE)
An observational study of Pulmonary Embolism, run by Walter Reed Army Medical Center.
Trial summary
Hypothesis: Increases in CRP, trop T, and BNP values will correlate significantly with right heart failure on echocardiogram and with mortality, ICU stay, hospital stay, and escalations in care. 1. Evaluate whether CRP, trop T, and BNP correlate significantly with right heart failure on echocardiogram. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Jun 2004to Jan 2006
- 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: Adult patients diagnosed with acute pulmonary embolism
Who may be able to join
- > 18 years old
- Acute PE (diagnosed by pulmonary angiogram, Computed tomography using the DVT/PE protocol, Ventilation/Perfusion (V/Q) scan read as high probability by the radiologist, or (+) lower extremity Doppler ultrasound with symptoms consistent with PE)
Who cannot join
- Hemodynamic instability (BP < 90/60, IV pressor support) on admission
- Acute respiratory failure on admission
- Treatment with thrombolytic therapy prior to enrollment
About this study
Hypothesis: Increases in CRP, trop T, and BNP values will correlate significantly with right heart failure on echocardiogram and with mortality, ICU stay, hospital stay, and escalations in care.
- Evaluate whether CRP, trop T, and BNP correlate significantly with right heart failure on echocardiogram.
- Evaluate whether CRP, trop T, BNP, and echocardiogram correlate significantly with clinical outcomes: mortality, ICU stay, hospital stay, and escalations in care.
- Compare each test's correlation with clinical outcomes to the others, to determine which test provides the best risk ratio.
- Compare each trop T value's correlation with echo findings and clinical outcomes to determine the optimal time to draw trop T levels on a patient presenting with acute PE.
- These tests will not be used in an attempt to establish a diagnosis of PE.
Read the detailed description
Purpose: This study will help us to determine whether laboratory tests used to evaluate cardiac function and blood flow (troponin T (trop T), C-reactive protein (CRP), and brain-natriuretic peptide (BNP)) correlate with findings on echocardiogram and with meaningful clinical outcomes when patients present with acute pulmonary embolism (PE). We will be studying these tests for prognostic purposes only, in patients with an established diagnosis of PE.
Research design: Prospective cohort study Methodology: Patients diagnosed with acute PE (see exclusion and inclusion criteria below) will be offered enrollment in the study. Once enrolled, he/she will then have a trans-thoracic echocardiogram (TTE) performed by a member of the cardiology service who will not be aware of the patient's clinical status, co-morbidities, or lab results (other than knowing that the patient has been diagnosed with acute PE). The patient will then have trop T, CRP, and BNP levels drawn (or added to laboratory tests that have already been drawn), which will be ordered by a member of the research team. CRP and BNP will be drawn only once, while trop T levels will be drawn every 4 hours for the first 24 hours, and every 8 hours from 24 to 48 hours. The primary team managing the patients will be privy to both the additional laboratory values ordered by the research team and the results of the TTE.
Each patient will be followed for the remainder of their hospital stay by a member of the research team. The following outcomes will be recorded: deaths, length of ICU stay, length of hospital stay, and escalations in care (pressor support, cardiopulmonary resuscitation (CPR), administration of thrombolytics, mechanical ventilation, ICU transfer).
- Conditions
- Pulmonary Embolism
- Keywords
- pulmonary embolism, risk stratification, prognosis, troponin, Brain natriuretic peptide, echocardiogram
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients diagnosed with acute pulmonary embolism were enrolled in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
Measured: In hospital mortality.
Secondary outcomes (1)
Escalations in care - thrombolysis, CPR, mechanical intubation, transfer to ICU, IV vasopressor administration
Measured: In hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2007 (estimated)
- Study startJun 2004
- Study completionJan 2006
Why it stopped: Study was stopped due to slow accrual of patients.
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Medical Center
- Sponsor type
- US federal agency
- Investigators
- Aaron B Holley, MD, Principal investigator, Walter Reed Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00562042
- Sponsor's protocol ID
- 04-10006
- Status last verified
- Nov 2007
- First submitted
- 20 Nov 2007
- Last updated
- 21 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Stratification for Patients Presenting With Acute Pulmonary Embolism (PE)
- ClinicalTrials.gov ID
- NCT00562042
- Acronym / sponsor ID
- 04-10006
- Conditions
- Pulmonary Embolism
- Keywords
- pulmonary embolism, risk stratification, prognosis, troponin, Brain natriuretic peptide, echocardiogram
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was stopped due to slow accrual of patients.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Walter Reed Army Medical CenterUS federal agency
- Study start
- Jun 2004
- Study completion
- Jan 2006 (actual)
- First posted
- 21 Nov 2007 (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.
Hypothesis: Increases in CRP, trop T, and BNP values will correlate significantly with right heart failure on echocardiogram and with mortality, ICU stay, hospital stay, and escalations in care.
- Evaluate whether CRP, trop T, and BNP correlate significantly with right heart failure on echocardiogram.
- Evaluate whether CRP, trop T, BNP, and echocardiogram correlate significantly with clinical outcomes: mortality, ICU stay, hospital stay, and escalations in care.
- Compare each test's correlation with clinical outcomes to the others, to determine which test provides the best risk ratio.
- Compare each trop T value's correlation with echo findings and clinical outcomes to determine the optimal time to draw trop T levels on a patient presenting with acute PE.
- These tests will not be used in an attempt to establish a diagnosis of PE.
Detailed description
Purpose: This study will help us to determine whether laboratory tests used to evaluate cardiac function and blood flow (troponin T (trop T), C-reactive protein (CRP), and brain-natriuretic peptide (BNP)) correlate with findings on echocardiogram and with meaningful clinical outcomes when patients present with acute pulmonary embolism (PE). We will be studying these tests for prognostic purposes only, in patients with an established diagnosis of PE.
Research design: Prospective cohort study Methodology: Patients diagnosed with acute PE (see exclusion and inclusion criteria below) will be offered enrollment in the study. Once enrolled, he/she will then have a trans-thoracic echocardiogram (TTE) performed by a member of the cardiology service who will not be aware of the patient's clinical status, co-morbidities, or lab results (other than knowing that the patient has been diagnosed with acute PE). The patient will then have trop T, CRP, and BNP levels drawn (or added to laboratory tests that have already been drawn), which will be ordered by a member of the research team. CRP and BNP will be drawn only once, while trop T levels will be drawn every 4 hours for the first 24 hours, and every 8 hours from 24 to 48 hours. The primary team managing the patients will be privy to both the additional laboratory values ordered by the research team and the results of the TTE.
Each patient will be followed for the remainder of their hospital stay by a member of the research team. The following outcomes will be recorded: deaths, length of ICU stay, length of hospital stay, and escalations in care (pressor support, cardiopulmonary resuscitation (CPR), administration of thrombolytics, mechanical ventilation, ICU transfer).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients diagnosed with acute pulmonary embolism were enrolled in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with acute pulmonary embolism
Key inclusion criteria (2 listed)
- > 18 years old
- Acute PE (diagnosed by pulmonary angiogram, Computed tomography using the DVT/PE protocol, Ventilation/Perfusion (V/Q) scan read as high probability by the radiologist, or (+) lower extremity Doppler ultrasound with symptoms consistent with PE)
Key exclusion criteria (3 listed)
- Hemodynamic instability (BP < 90/60, IV pressor support) on admission
- Acute respiratory failure on admission
- Treatment with thrombolytic therapy prior to enrollment
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
mortality
Time frame: In hospital mortality.
1 secondary outcome
Escalations in care - thrombolysis, CPR, mechanical intubation, transfer to ICU, IV vasopressor administration
Time frame: In hospital
Results and safety
The study was stopped early (reason given: Study was stopped due to slow accrual of patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2007.
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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.
Aaron B Holley, MD principal investigator
Walter Reed Army Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism, run by Walter Reed Army Medical Center.
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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 21 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: Study was stopped due to slow accrual of patients.). Results are not available in the source record.
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?
mortality (time frame: In hospital mortality.). 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 21 Nov 2007.