AtherosclerosisNCT00256035
Interleukin-4 (IL-4) as a Marker of Atherosclerosis
A study testing Measuring IL-4 levels in people with Atherosclerosis and Ischemic Heart Disease, run by Melbourne Health.
Trial summary
In recent years, medical research into the cause and progression of heart disease due to narrowing and blockage of blood vessels to the heart muscle has improved the understanding of ischemic heart disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atherosclerosis, Ischemic Heart Disease
- What is being tested?
- Measuring IL-4 levels
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients (either sex and any age) presenting in the settings described will be eligible to participate.
Who cannot join
- An unwillingness to participate.
About this study
Official title: IL-4 as a Marker of Atherosclerosis
In recent years, medical research into the cause and progression of heart disease due to narrowing and blockage of blood vessels to the heart muscle has improved the understanding of ischemic heart disease. It is now accepted that both the development and later progression with sudden blockage of blood vessels are associated with inflammation, although it remains unknown exactly what triggers this inflammatory process. It is possible that new blood tests which measure markers of inflammation in the bloodstream may be useful to help identify patients at risk of heart damage and assess response to treatment.
The study plans to assess a new blood test for a known marker of inflammation (IL-4) in patients with heart disease.
Read more
The hypothesis of this study is that, the cytokine, IL-4, measured by a new assay, is abnormally elevated in the blood of patients with coronary artery disease.
Also hypothesized is that the degree of abnormality of blood IL-4, is related to important clinical events in such patients, including severity of disease, acute complications, and treatment.
Read the detailed description
This is a single centre, prospective, non randomised, non controlled, pilot study of the potential abnormality of a new test group of patients in whom the results are postulated to be abnormal.
The specific aims of the study are:
- To measure IL-4 by a new rapid on-site technique in patients with documented coronary artery disease presenting in a variety of acute clinical circumstances
- To evaluate any abnormal measurements in relation to the severity of the disease, acute vascular complication and newly prescribed medications.
It is proposed to study 4 small groups of patients with ischemic heart disease.
- Patients with unstable coronary artery disease admitted to the Coronary Care Unit. They will be studied on admission and then daily until coronary angiography is performed.
- Patients having coronary angioplasty. They will be studied before, immediately after and 24 hours after the procedure.
- Patients having coronary artery bypass grafting will be studied immediately after and 24 hours post surgery.
- Patients with stable coronary artery disease about to receive a statin and or angiotensin-converting enzyme inhibitor therapy will be studied before and twice weekly after commencement of therapy for 4 weeks.
- Conditions
- Atherosclerosis, Ischemic Heart Disease
- Being tested
- Measuring IL-4 levels
- Medical subject headings
- Atherosclerosis, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measuring IL-4 levelsProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Unstable coronary artery disease | Other | Patients with unstable coronary artery disease will have daily IL6 levels Receives: Procedure: Measuring IL-4 levels |
| Coronary Angioplasty Patients | Other | Patients having coronary angioplasty will have levels taken before and immediately after the proceedure and 24 hours post. Receives: Procedure: Measuring IL-4 levels |
| Coronary bypass grafts patients | Other | Patients will have levels collected immediately after and 24 hours post procedure Receives: Procedure: Measuring IL-4 levels |
| Stable coronary Artery Diseaese Patients | Other | Once the patients are commenced on treatment with statins and or angiotensin converting enzyme they will have twice weekly levels taken Receives: Procedure: Measuring IL-4 levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the IL-4 by a new rapid point-of-care technique in patients with documented coronary artery disease presenting in a variety of acute clinical circumstances
Measured: Hospital Discharge
Secondary outcomes (1)
To evaluate any abnormal measurements in relation to the severity of the disease, acute vascular complications, and newly prescribed medications
Measured: Hospital Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melbourne Health
- Sponsor type
- University, hospital or other
- Collaborators
- The Intensive Care Unit Departmental Funding
- Investigators
- Megan Robertson, Principal investigator, Melbourne Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00256035
- Sponsor's protocol ID
- 2002.156
- Status last verified
- Apr 2015
- First submitted
- 17 Nov 2005
- Last updated
- 27 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IL-4 as a Marker of Atherosclerosis
- ClinicalTrials.gov ID
- NCT00256035
- Acronym / sponsor ID
- 2002.156
- Conditions
- Atherosclerosis, Ischemic Heart Disease
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Melbourne HealthUniversity, hospital or other
- Collaborators
- The Intensive Care Unit Departmental Funding
- First posted
- 21 Nov 2005 (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.
In recent years, medical research into the cause and progression of heart disease due to narrowing and blockage of blood vessels to the heart muscle has improved the understanding of ischemic heart disease. It is now accepted that both the development and later progression with sudden blockage of blood vessels are associated with inflammation, although it remains unknown exactly what triggers this inflammatory process. It is possible that new blood tests which measure markers of inflammation in the bloodstream may be useful to help identify patients at risk of heart damage and assess response to treatment.
The study plans to assess a new blood test for a known marker of inflammation (IL-4) in patients with heart disease.
The hypothesis of this study is that, the cytokine, IL-4, measured by a new assay, is abnormally elevated in the blood of patients with coronary artery disease.
Also hypothesized is that the degree of abnormality of blood IL-4, is related to important clinical events in such patients, including severity of disease, acute complications, and treatment.
Detailed description
This is a single centre, prospective, non randomised, non controlled, pilot study of the potential abnormality of a new test group of patients in whom the results are postulated to be abnormal.
The specific aims of the study are:
- To measure IL-4 by a new rapid on-site technique in patients with documented coronary artery disease presenting in a variety of acute clinical circumstances
- To evaluate any abnormal measurements in relation to the severity of the disease, acute vascular complication and newly prescribed medications.
It is proposed to study 4 small groups of patients with ischemic heart disease.
- Patients with unstable coronary artery disease admitted to the Coronary Care Unit. They will be studied on admission and then daily until coronary angiography is performed.
- Patients having coronary angioplasty. They will be studied before, immediately after and 24 hours after the procedure.
- Patients having coronary artery bypass grafting will be studied immediately after and 24 hours post surgery.
- Patients with stable coronary artery disease about to receive a statin and or angiotensin-converting enzyme inhibitor therapy will be studied before and twice weekly after commencement of therapy for 4 weeks.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Unstable coronary artery disease | Other | Procedure: Measuring IL-4 levelsPatients with unstable coronary artery disease will have daily IL6 levels |
| Coronary Angioplasty Patients | Other | Procedure: Measuring IL-4 levelsPatients having coronary angioplasty will have levels taken before and immediately after the proceedure and 24 hours post. |
| Coronary bypass grafts patients | Other | Procedure: Measuring IL-4 levelsPatients will have levels collected immediately after and 24 hours post procedure |
| Stable coronary Artery Diseaese Patients | Other | Procedure: Measuring IL-4 levelsOnce the patients are commenced on treatment with statins and or angiotensin converting enzyme they will have twice weekly levels taken |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients (either sex and any age) presenting in the settings described will be eligible to participate.
Key exclusion criteria (1 listed)
- An unwillingness to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measuring IL-4 levels | Procedure or surgery | Coronary Angioplasty Patients, Coronary bypass grafts patients, Stable coronary Artery Diseaese Patients, Unstable coronary artery disease |
Primary outcome
To measure the IL-4 by a new rapid point-of-care technique in patients with documented coronary artery disease presenting in a variety of acute clinical circumstances
Time frame: Hospital Discharge
1 secondary outcome
To evaluate any abnormal measurements in relation to the severity of the disease, acute vascular complications, and newly prescribed medications
Time frame: Hospital Discharge
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2015.
Related trials for Atherosclerosis
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
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.
Megan Robertson principal investigator
Melbourne Health
Questions about this trial
What is this clinical trial studying?
A study testing Measuring IL-4 levels in people with Atherosclerosis and Ischemic Heart Disease, run by Melbourne Health.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 27 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
To measure the IL-4 by a new rapid point-of-care technique in patients with documented coronary artery disease presenting in a variety of acute clinical circumstances (time frame: Hospital Discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2015.