Risk Stratification for Patients Presenting With Acute Pulmonary Embolism (PE)
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|ClinicalTrials.gov Identifier: NCT00562042|
Recruitment Status : Terminated (Study was stopped due to slow accrual of patients.)
First Posted : November 21, 2007
Last Update Posted : November 21, 2007
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.
|Condition or disease|
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 Type :||Observational|
|Actual Enrollment :||28 participants|
|Official Title:||Risk Stratification for Patients Presenting With Acute Pulmonary Embolism (PE)|
|Study Start Date :||June 2004|
|Actual Study Completion Date :||January 2006|
Patients diagnosed with acute pulmonary embolism were enrolled in this study.
- mortality [ Time Frame: In hospital mortality. ]
- Escalations in care - thrombolysis, CPR, mechanical intubation, transfer to ICU, IV vasopressor administration [ Time Frame: In hospital ]
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): NCT00562042
|Principal Investigator:||Aaron B Holley, MD||Walter Reed Army Medical Center|