NCT00562042

Brief 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. 1.Evaluate whether CRP, trop T, and BNP correlate significantly with right heart failure on echocardiogram.
  2. 2.Evaluate whether CRP, trop T, BNP, and echocardiogram correlate significantly with clinical outcomes: mortality, ICU stay, hospital stay, and escalations in care.
  3. 3.Compare each test's correlation with clinical outcomes to the others, to determine which test provides the best risk ratio.
  4. 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. 5.These tests will not be used in an attempt to establish a diagnosis of PE.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2004

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 21, 2007

Completed
Last Updated

November 21, 2007

Status Verified

November 1, 2007

First QC Date

November 20, 2007

Last Update Submit

November 20, 2007

Conditions

Pulmonary Embolism

Keywords

pulmonary embolismrisk stratificationprognosistroponinBrain natriuretic peptideechocardiogram

Outcome Measures

Primary Outcomes (1)

  • mortality

    In hospital mortality.

Secondary Outcomes (1)

  • Escalations in care - thrombolysis, CPR, mechanical intubation, transfer to ICU, IV vasopressor administration

    In hospital

Study Arms (1)

1

Patients diagnosed with acute pulmonary embolism were enrolled in this study.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients diagnosed with acute pulmonary embolism

You may qualify if:

  • \> 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)

You may not qualify if:

  • Hemodynamic instability (BP \< 90/60, IV pressor support) on admission
  • Acute respiratory failure on admission
  • Treatment with thrombolytic therapy prior to enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Aaron B Holley, MD

    Walter Reed Army Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
FED

Study Record Dates

First Submitted

November 20, 2007

First Posted

November 21, 2007

Study Start

June 1, 2004

Study Completion

January 1, 2006

Last Updated

November 21, 2007

Record last verified: 2007-11