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Risk Stratification for Patients Presenting With Acute Pulmonary Embolism (PE)

This study has been terminated.
(Study was stopped due to slow accrual of patients.)
Sponsor:
Information provided by:
Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT00562042
First received: November 20, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose

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. Evaluate whether CRP, trop T, BNP, and echocardiogram correlate significantly with clinical outcomes: mortality, ICU stay, hospital stay, and escalations in care.
  3. Compare each test's correlation with clinical outcomes to the others, to determine which test provides the best risk ratio.
  4. 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.
  5. These tests will not be used in an attempt to establish a diagnosis of PE.

Condition
Pulmonary Embolism

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Stratification for Patients Presenting With Acute Pulmonary Embolism (PE)

Resource links provided by NLM:


Further study details as provided by Walter Reed Army Medical Center:

Primary Outcome Measures:
  • mortality [ Time Frame: In hospital mortality. ]

Secondary Outcome Measures:
  • Escalations in care - thrombolysis, CPR, mechanical intubation, transfer to ICU, IV vasopressor administration [ Time Frame: In hospital ]

Enrollment: 28
Study Start Date: June 2004
Study Completion Date: January 2006
Groups/Cohorts
1
Patients diagnosed with acute pulmonary embolism were enrolled in this study.

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult patients diagnosed with acute pulmonary embolism

Criteria

Inclusion Criteria:

  • > 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)

Exclusion Criteria:

  • Hemodynamic instability (BP < 90/60, IV pressor support) on admission
  • Acute respiratory failure on admission
  • Treatment with thrombolytic therapy prior to enrollment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00562042

Sponsors and Collaborators
Walter Reed Army Medical Center
Investigators
Principal Investigator: Aaron B Holley, MD Walter Reed Army Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00562042     History of Changes
Other Study ID Numbers: 04-10006
Study First Received: November 20, 2007
Last Updated: November 20, 2007
Health Authority: United States: Federal Government

Keywords provided by Walter Reed Army Medical Center:
pulmonary embolism
risk stratification
prognosis
troponin
Brain natriuretic peptide
echocardiogram

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Cardiovascular Diseases
Embolism and Thrombosis
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014