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Evaluation of ST2 and IL-33 in Patients Presenting to the Emergency Department With Trouble Breathing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00707811
Recruitment Status : Unknown
Verified June 2008 by The Cleveland Clinic.
Recruitment status was:  Recruiting
First Posted : July 1, 2008
Last Update Posted : July 1, 2008
Critical Diagnostics
Information provided by:
The Cleveland Clinic

Brief Summary:
Trouble breathing (dyspnea) is a nonspecific symptom associated with many diseases such as chronic obstructive pulmonary disease (lung disorder in which the flow of air to the lungs is blocked), asthma, pneumonia, pulmonary hypertension (high blood pressure in the lungs), congestive heart failure (fluid build-up in the lungs because the heart is not pumping normally) and pulmonary embolism (blood clot in the lungs). The purpose of this study is to test two blood markers called ST2 and IL-33. Blood markers are proteins or other compounds in your blood that physicians use to diagnose different diseases and to determine what the course of an illness will be. In preliminary research studies, ST2 and IL-33 have been elevated in patients with a wide variety of diseases where the lungs are the primary organs involved. This research study will further investigate the ability of ST2 and IL-33 to predict the severity of disease and the possible use of ST2 and IL-33 in the diagnosis of various lung diseases.

Condition or disease
Chronic Obstructive Pulmonary Disease Asthma Pulmonary Embolism Pneumonia Pulmonary Hypertension

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of ST2 and IL-33 for Risk Stratification and Diagnosis in Patients Presenting to the Emergency Department With Dyspnea
Study Start Date : April 2008
Estimated Primary Completion Date : June 2009
Estimated Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Any cause of mortality [ Time Frame: 180 days ]

Secondary Outcome Measures :
  1. Rehospitalization of a pulmonary etiology and/or significant lung morbidity (transplant, intubation, ARDS, pneumonia, pulmonary hypertension, etc) [ Time Frame: 180 days ]
  2. Mortality with a pulmonary specific etiology [ Time Frame: 180 days ]
  3. Any cause morbidity [ Time Frame: 180 days ]

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting to the Cleveland Clinic Emergency Department with signs and/or symptoms of dyspnea (trouble breathing)

Inclusion Criteria:

  • Presenting to the Emergency Department with signs and symptoms of dyspnea (short of breath, tachypnea, hyperventilation, etc) within the last 24 hours
  • Normal cardiac output as measured by noninvasive bioimpedance
  • Greater than or equal to 18 years of age
  • Patient or legal representative willing and able to provide informed consent and comply with study procedures

Exclusion Criteria:

  • A history of congestive heart failure and a BNP > 500pg/mL (or NTproBNP > 900pg/mL) if obtained by the treating physician
  • Treating physician suspects patient has new onset congestive heart failure
  • ECG changes diagnostic of acute myocardial ischemia/infarction
  • Ischemic chest pain within the prior 24 hours by history
  • Obvious chest trauma

Information from the National Library of Medicine

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 identifier (NCT number): NCT00707811

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Contact: Justin L Benoit, BS
Contact: William F Peacock, MD 216-445-4557

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United States, Ohio
The Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Justin L Benoit, BS   
Contact: William F Peacock, MD    216-445-4557   
Principal Investigator: Justin L Benoit, BS         
Sponsors and Collaborators
The Cleveland Clinic
Critical Diagnostics
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Principal Investigator: Justin L Benoit, BS The Cleveland Clinic
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Justin Benoit, Medical Student, The Cleveland Clinic Identifier: NCT00707811    
Other Study ID Numbers: CCED08043
First Posted: July 1, 2008    Key Record Dates
Last Update Posted: July 1, 2008
Last Verified: June 2008
Keywords provided by The Cleveland Clinic:
Shortness of Breath
Trouble Breathing
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Hypertension, Pulmonary
Pulmonary Embolism
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Respiratory Tract Infections
Embolism and Thrombosis