Peripheral Blood Mononuclear Cell Single Photon Emission Computed Tomography in Patients with Atherosclerotic Disease; Shedding light on the migration of immune cells in vascular disease.
- Conditions
- Atherosclerosisvascular disease10003216
- Registration Number
- NL-OMON37041
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Healthy controls
* Adults (either gender) * 18 years
* Willing and able to participate in study protocol
Cardiovascular patients
* Adult patients (either gender) * 18 years
* For patients using statins, angiotensin-converting enzyme (ACE) inhibitors (ACE-I) or angiotensin-receptor blockers (ARBs), non-statin lipid-modifying therapy, thiazolidinediones, inhaled steroids, or leukotriene modifying agents; use of a stable dose for at least 6 weeks prior to the first visit.
* Documented * atherosclerotic vascular disease (e.g., CAD, peripheral arterial disease, aortic atherosclerosis or abdominal aortic aneurysm (< 5 cm), carotid disease or cerebrovascular disease) and clinically stable for at least 3 months prior to screening, or or at elevated risk for CVD:
oBMI > 27.
oHDL < 1.0.
oMetabolic syndrome, as defined by the worldwide definition by the International Diabetes Federation criteria.
oDiabetes mellitus type II . ;* Documentation will include one or more of the following: history of myocardial infarction or stroke or, objective diagnostic testing. ( Examples include but are not limited to: Exercise treadmill test, Stress echocardiography, Myocardial perfusion scintigraphy, Right or left common carotid intima-media thickness (CIMT) by ultrasound > 75th percentile by American Society of Echocardiography, Presence of carotid plaque by carotid ultrasound (focal thickening > 50% or CIMT > 1.5 mm), Abdominal aortic aneurysm by CT or ultrasound, Coronary artery calcium score > 100 Agatston units in patients < 60 years of age, CT or conventional coronary or peripheral angiography with at least one moderate or severe luminal stenosis, CT coronary angiography with one or more atherosclerotic plaques demonstrating positive remodeling or hypodense plaque morphology, Moderate or severe aortic atherosclerosis by CT or Transesophageal echocardiography, History of revascularization procedure (e.g., coronary or peripheral arterial bypass grafting, percutaneous coronary or peripheral intervention, carotid endarterectomy).
Healthy controls are not eligible if they meet one of the criteria listed below:
* Any known systemic chronic disorders/medical condition or chronic use of systemic medication that could interfere with the conduct of the study in the opinion of the investigator.
*Standard contra-indications to MRI, PET, and CT.
* Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.
Cardiovascular patients are not eligible if they meet one of the criteria listed below:
*Auto-immune disease/vasculitis, other active inflammatory diseases, proven or suspected bacterial infections. Recent (<1 month prior to screening) or ongoing serious infection requiring IV antibiotic therapy that could interfere with the conduct of the study in the opinion of the investigator.
*Known systemic disorders such as hepatic, renal, hematologic, and malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator.
*Recent (< 1 month prior to screening) or current treatment with medications that may have a significant effect on plaque inflammation as measured by plaque TBR, including: oral, rectal, or injectable corticosteroids or immunosuppressive medications (e.g., cyclosporine, methotrexate, tacrolimus, azathioprine, anti-thymocyte globulin, sirolimus, anti-TNF agents such as infliximab, anti-IL6 therapy such as tocilizumab, or anti-IL1 therapy such as anakinra).
*Poorly controlled diabetes defined as hemoglobin A1c (HbA1c) >7.5% due to inability to comply with recommended diabetes treatment.
*History of anaphylaxis, anaphylactoid (resembling anaphylaxis) reactions, or severe allergic responses.
*Planned cardiac surgery, PCI or carotid stenting, or major non-cardiac surgery during the course of the study period that could interfere with the conduct of the study in the opinion of the investigator.
*Standard contra-indications to MRI, PET, and CT.
*Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameters:<br /><br>The assessment of SPECT images at the site of atherosclerosis, reported as<br /><br>geometric mean counts per minute per 100 pixels divided by the injected dose of<br /><br>radioactivity.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary study parameters/endpoints<br /><br>- Association between the degree of monocyte influx/tracer uptake at the site<br /><br>of atherosclerosis and TBR as measured with FDG-PETCT.<br /><br>- Association between the degree of monocyte influx/tracer uptake at the site<br /><br>of atherosclerosis and DCE-MRI signal.<br /><br>- Association between the degree of monocyte influx/tracer uptake at the site<br /><br>of atherosclerosis and laboratory parameters; for example but not limited to<br /><br>inflammatory parameters.<br /><br>- To evaluate differences between SPECT signal in subjects with cardiovascular<br /><br>disease and healthy controls. </p><br>