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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by The Cleveland Clinic.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Critical Diagnostics
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00707811
First received: June 27, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
  Purpose

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
Chronic Obstructive Pulmonary Disease
Asthma
Pulmonary Embolism
Pneumonia
Pulmonary Hypertension

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Any cause of mortality [ Time Frame: 180 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rehospitalization of a pulmonary etiology and/or significant lung morbidity (transplant, intubation, ARDS, pneumonia, pulmonary hypertension, etc) [ Time Frame: 180 days ] [ Designated as safety issue: No ]
  • Mortality with a pulmonary specific etiology [ Time Frame: 180 days ] [ Designated as safety issue: No ]
  • Any cause morbidity [ Time Frame: 180 days ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Plasma


Estimated Enrollment: 200
Study Start Date: April 2008
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
  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

Patients presenting to the Cleveland Clinic Emergency Department with signs and/or symptoms of dyspnea (trouble breathing)

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00707811

Contacts
Contact: Justin L Benoit, BS benoitj@ccf.org
Contact: William F Peacock, MD 216-445-4557 peacocw@ccf.org

Locations
United States, Ohio
The Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Justin L Benoit, BS         benoitj@ccf.org    
Contact: William F Peacock, MD     216-445-4557     peacocw@ccf.org    
Principal Investigator: Justin L Benoit, BS            
Sponsors and Collaborators
The Cleveland Clinic
Critical Diagnostics
Investigators
Principal Investigator: Justin L Benoit, BS The Cleveland Clinic
  More Information

No publications provided by The Cleveland Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Justin Benoit, Medical Student, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00707811     History of Changes
Other Study ID Numbers: CCED08043
Study First Received: June 27, 2008
Last Updated: June 27, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
Dyspnea
Shortness of Breath
Trouble Breathing
ST2
IL-33

Additional relevant MeSH terms:
Asthma
Embolism
Emergencies
Hypertension
Hypertension, Pulmonary
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Pneumonia
Pulmonary Embolism
Lung Diseases, Obstructive
Bronchial Diseases
 Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Disease Attributes
Pathologic Processes
Respiratory Tract Infections

ClinicalTrials.gov processed this record on May 22, 2013