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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.

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. - Illuminate

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON37041
Enrollment
30
Registered
2012-09-10
Start date
2012-10-26
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis vascular disease

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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 ( 27. oHDL 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

Exclusion criteria

Exclusion criteria: 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 (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.

Design outcomes

Primary

MeasureTime frame
Main study parameters: The assessment of SPECT images at the site of atherosclerosis, reported as geometric mean counts per minute per 100 pixels divided by the injected dose of radioactivity.

Secondary

MeasureTime frame
Secondary study parameters/endpoints - Association between the degree of monocyte influx/tracer uptake at the site of atherosclerosis and TBR as measured with FDG-PETCT. - Association between the degree of monocyte influx/tracer uptake at the site of atherosclerosis and DCE-MRI signal. - Association between the degree of monocyte influx/tracer uptake at the site of atherosclerosis and laboratory parameters; for example but not limited to inflammatory parameters. - To evaluate differences between SPECT signal in subjects with cardiovascular disease and healthy controls.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)