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NCT Number: NCT00707811

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Exclusion criteria

for Blood Draw:

  • 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

Treatment and study plan

Primary outcomes

  1. Any cause of mortality

    Time frame: 180 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • Critical Diagnostics

Registry information

Official study title

Evaluation of ST2 and IL-33 for Risk Stratification and Diagnosis in Patients Presenting to the Emergency Department With Dyspnea

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jul 1, 2008
Registry last updated
Mar 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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