Chronic Obstructive Pulmonary DiseaseNCT00707811
Evaluation of ST2 and IL-33 in Patients Presenting to the Emergency Department With Trouble Breathing
An observational study of Chronic Obstructive Pulmonary Disease and Asthma, run by The Cleveland Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Asthma, Pulmonary Embolism
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to the Cleveland Clinic Emergency Department with signs and/or symptoms of dyspnea (trouble breathing)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of ST2 and IL-33 for Risk Stratification and Diagnosis in Patients Presenting to the Emergency Department With Dyspnea
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
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma, Pulmonary Embolism, Pneumonia, Heart Failure, Dyspnea
What is being measured
The primary outcome is the main question the study is designed to answer.
Any cause of mortality
Measured: 180 days
Secondary outcomes (3)
Rehospitalization of a pulmonary etiology and/or significant lung morbidity (transplant, intubation, ARDS, pneumonia, pulmonary hypertension, etc)
Measured: 180 days
Mortality with a pulmonary specific etiology
Measured: 180 days
Any cause morbidity
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2008 (estimated)
- Study startApr 2008
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Critical Diagnostics
- Responsible party
- Sponsor
- Investigators
- Justin L Benoit, BS, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00707811
- Sponsor's protocol ID
- CCED08043
- Status last verified
- Mar 2024
- First submitted
- 27 Jun 2008
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21060320
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of ST2 and IL-33 for Risk Stratification and Diagnosis in Patients Presenting to the Emergency Department With Dyspnea
- ClinicalTrials.gov ID
- NCT00707811
- Acronym / sponsor ID
- CCED08043
- Conditions
- Chronic Obstructive Pulmonary Disease, Asthma, Pulmonary Embolism, Pneumonia, Congestive Heart Failure
- Keywords
- Dyspnea, Shortness of Breath, Trouble Breathing, ST2, IL-33
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Critical Diagnostics
- Study start
- Apr 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 1 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the Cleveland Clinic Emergency Department with signs and/or symptoms of dyspnea (trouble breathing)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Any cause of mortality
Time frame: 180 days
3 secondary outcomes
Rehospitalization of a pulmonary etiology and/or significant lung morbidity (transplant, intubation, ARDS, pneumonia, pulmonary hypertension, etc)
Time frame: 180 days
Mortality with a pulmonary specific etiology
Time frame: 180 days
Any cause morbidity
Time frame: 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Derived from this study: PubMed 21060320Lloyd 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin L Benoit, BS principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Asthma, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Any cause of mortality (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00707811, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.