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

NCT00707811 | Completed

• 1 other identifier: CCED08043
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; Asthma; Pulmonary Embolism; Pneumonia; Congestive Heart Failure

Keywords

Dyspnea; Shortness of Breath; Trouble Breathing; ST2; IL-33

Outcome Measures

Primary Outcomes (1)

• Any cause of mortality

  180 days

Secondary Outcomes (3)

• Rehospitalization of a pulmonary etiology and/or significant lung morbidity (transplant, intubation, ARDS, pneumonia, pulmonary hypertension, etc)

  180 days

• Mortality with a pulmonary specific etiology

  180 days

• Any cause morbidity

  180 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• ECG changes diagnostic of acute myocardial ischemia/infarction
• Ischemic chest pain within the prior 24 hours by history
• Obvious chest trauma
• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Critical Diagnostics: collaborator

Study Sites (1)

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Lloyd CM, Hessel EM. Functions of T cells in asthma: more than just T(H)2 cells. Nat Rev Immunol. 2010 Dec;10(12):838-48. doi: 10.1038/nri2870. Epub 2010 Nov 9.

  PMID: 21060320 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma; Pulmonary Embolism; Pneumonia; Heart Failure; Dyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Infections; Infections; Heart Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Justin L Benoit, BS

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2008
• First Posted: July 1, 2008
• Study Start: April 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

US (1)