Monocyte behaviour in human upon sympathetic stimulus via LBNP with and without beta-blocker therapy.
- Conditions
- Atherosclerosisvessel wall inflammation10003216
- Registration Number
- NL-OMON38648
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 30
Healthy controls
* Adults (either gender) * 18 years
* Willing and able to participate in study protocol;Splenectomized patients
* Adults (either gender) * 18 years
* History of traumatic splenectomy
* Participated in scientific research at the AMC previously and have given permission via informed consent to be willing to be contacted for other research at the AMC in the future.
* Willing and able to participate in study protocol;Cardiovascular patients
* Adults (either gender) * 18 years
* Cardiovascular patients are recognized by atherosclerotic cardiovascular disease, thus atherosclerosis in either coronary, carotid, aortic and/or peripheral arteries. The above needs to be documented in the history of the patient by one or more of the following:
o History of coronary heart disease (angina pectoris, myocardial infarction), cerebrovascular disease (stroke), peripheral arterial disease (claudicatio intermittens).
o Objective diagnostic (imaging) examinations, including 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), 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,
o History of revascularization procedure (e.g., coronary or peripheral arterial bypass grafting, percutaneous coronary or peripheral intervention, carotid endarterectomy).
* Willing and able to participate in study protocol
* 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.
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.
* Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.;Splenectomized patients are not eligible if they meet one of the criteria listed below:
* History of cardiovascular diseases (including atherosclerotic CVD, heartfailure, etc) or cardiovascular medication such as use of beta blocker therapy, calciumantagonists and CYP2D6 inhibitors.
* 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 asthma, 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.
* 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:
* Other cardiovasular disease than the previously defined atherosclerotic cardiovascular disease patients, including heart failure, cardiomyopathy, aneurysms, hypertensive heart disease, cor pulmonale, cardiac dysrhythmias including sick-sinussyndrome, 2nd- en 3rd degree AV-block, inflammatory heart disease such as endocarditis, myocarditis and rheumatic heart disease, valvular heart disease and congenital heart disease.
* Use of beta blocker therapy, calciumantagonists and CYP2D6 inhibitors (for example paroxetin, fluoxetin) within 3 months prior to screening visit are not allowed based on their effect on bloodpressure regulation.
* 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 asthma, 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.
* 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 parameter<br /><br>1. Changes in monocyte count and differentiation after LBNP in healthy<br /><br>volunteers </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary study parameters<br /><br><br /><br>2. Changes in monocyte count and differentiation after LBNP in splenectomized<br /><br>patients or patients with advanced cardiovascular disease.<br /><br>3. Differences between monocyte behaviour and characteristics in healthy<br /><br>volunteers, splenectomized patients and patients with advanced cardiovascular<br /><br>disease.<br /><br>4. Suppression of monocyte release via inhibition of nervous signaling pathway<br /><br>via B receptor blockade. </p><br>