Healthy Volunteers Clinical Trial
— ECOARMOfficial title:
The Role of Eicosanoids in the Cardiovascular Actions of Inhaled Nanoparticles
Verified date | May 2024 |
Source | University of Edinburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Nanoparticles (NPs) are minute pieces of material to which we are exposed every day in the air we breathe. Some are naturally occurring and have no impact on health, whereas others are produced from urban air pollution and can worsen diseases, particularly in the lungs and blood vessels. However, there is great interest in developing new NPs because of their unique properties that are useful for many applications, such as engineering, electronics and for drug delivery. At present it is unclear exactly what effects inhaled NPs have. Our current programme of research is designed to assess whether a specialized group of fats made in the body (called eicosanoids) drive the cardiovascular effects of NPs. The changes in the profiles of these fats will provide unique fingerprints that could be used to predict the actions of new NPs. In the proposed clinical study we shall investigate the effects of both environmental and manufactured carbonaceous NPs on the lungs, blood vessels, blood clotting, and levels of eicosanoids in blood and urine. We have previously investigated the cardiovascular effects of carbon nanoparticles after inhalation in man, and these experiments will investigate how the shape, size and composition of carbon particles influence these responses. These experiments will provide new insight into how NPs affect the body and pave the way for new ways to predict the toxic effects of NPs (reducing the need for animal experiments). The findings will enable the design of novel NP without the harmful characteristics of those found in air pollution.
Status | Completed |
Enrollment | 26 |
Est. completion date | November 27, 2020 |
Est. primary completion date | March 29, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: - Man or woman between 18 to 40 years of age, inclusive - Judged to be in good health based on medical history, physical examination, vital signs and laboratory tests - Body mass index (weight kg/m2) between 18 and 35 kg/m2 (inclusive), and body weight between 50 kg and 120 kg (inclusive). - Willing/able to donate blood (and meets the site's blood donor criteria). - No severe or significant medical condition and without intercurrent illness (e.g. viral cold or flu, chest infection) - Not taking any regular oral or intravenous medication. - Must be willing to abstain from food and caffeine-containing beverages for at least 12 hours beforehand, and alcohol for 24 hours beforehand. Exclusion Criteria: - Smoked tobacco or related products within 1 year prior to the study - Asthmatic - Occupation with high exposure to air pollution or other inhaled irritant - Severe or significant medical condition - Intercurrent illness (e.g. viral cold or flu, chest infection) - Use of any regular oral or intravenous prescription medication, or non-prescription (including aspirin, ibuprofen, paracetamol, vitamins and herbal supplements), and not at all in the 7 days prior to the study - Allergy or contraindication to vasodilator drugs (e.g. acetylcholine or sodium nitroprusside) - Major or traumatic surgery within 12 weeks of screening - Pregnant or still lactating prior to dose administration (women only) - Given blood in the 3 months prior to the study |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Centre for Cardiovascular Science | Edinburgh | Midlothian |
Lead Sponsor | Collaborator |
---|---|
University of Edinburgh | NHS Lothian |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood eicosanoid levels | Eicosanoids in blood (pg/mL) | Results available within 6 months of final study visit | |
Primary | Urine eicosanoid levels | Eicosanoids in urine (pg/mL) | Results available within 6 months of final study visit | |
Secondary | blood pressure | systolic/diastolic blood pressure (mmHg/mmHg) | Results available immediately at time of measurement | |
Secondary | Heart rate | Heart rate (bpm) | Results available immediately at time of measurement | |
Secondary | Lung function (FEV1) | Forced expiratory volume (% predicted litres) | Results available immediately at time of measurement | |
Secondary | Lung function (FVC) | Forced vital capacity (% predicted litres) | Results available immediately at time of measurement | |
Secondary | Full blood count | Blood cell counts (cells/mL) | Results available within 3 months of study visit | |
Secondary | Coagulation screen | Activated partial thromboplasmin time (seconds) | Results available within 3 months of study visit | |
Secondary | Internal normailised ratio | blood INR (ratio, arbitrary units) | Results available within 3 months of study visit | |
Secondary | C-reactive protein | Serum CRP levels (pg/mL) | Results available within 3 months of study visit | |
Secondary | Tumour necrosis factor | Blood TNFa levels (pg/mL) | Results available within 6 months of study visit | |
Secondary | Interleukin-6 | Blood IL-6 levels (pg/mL) | Results available within 6 months of study visit | |
Secondary | Blood coagulability (low-shear) | Area of thrombus on arterial strip from low sheer-stress Badimon chamber (micrometers squared) | Results available within 6 months of study visit | |
Secondary | Blood coagulability (high-shear) | Area of thrombus on arterial strip from high sheer-stress Badimon chambers (micrometers squared) | Results available within 6 months of study visit | |
Secondary | Vascular responsiveness (endothelium-dependent vasodilator) | Forearm blood flow to acetylcholine (mL blood/mL 100g tissue per min) | Results available within 1 year of study visit | |
Secondary | Vascular responsiveness (endothelium-independent vasodilator) | Forearm blood flow to sodium nitroprusside (mL blood/mL 100g tissue per min) | Results available within 1 year of study visit |
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