Blood BiomarkersECOARMNCT03659864
The Role of Eicosanoids in the Cardiovascular Actions of Inhaled Nanoparticles
A study testing diesel exhaust particulate, carbon nanoparticles and small graphene oxide in people with Blood Biomarkers and Vasodilation, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Biomarkers, Vasodilation, Blood Clotting
- What is being tested?
- diesel exhaust particulate, carbon nanoparticles and small graphene oxide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Oct 2018to 27 Nov 2020
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Centre for Cardiovascular Science
Edinburgh, Midlothian, EH16 4SB
About this study
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.
Read the detailed description
This study will investigate the biological effects of inhaling different nanoparticles in healthy volunteers. We will compare 4 different types of nanoparticles: diesel exhaust nanoparticles (a nanoparticle with a complex mixture of chemicals), carbon black nanoparticles (a 'simple, clean' carbon nanoparticle) and two different sizes of graphene oxide (flat flakes of carbon), as well as inhalation of filtered air for comparison. Volunteers will be split randomly into 2 groups and each will be exposed to 3 nanoparticles, separately in a randomised order, with at least 2 weeks between the exposures (Cohort study with double blind randomised cross over design).
Screening visit 30 healthy non-smoking volunteers will be recruited. The volunteer will attend a screening visit at the Clinical Research Facility (CRF) at the Royal Infirmary of Edinburgh (RIE). Eligibility will be confirmed and consent taken. Baseline measurements of lung function (FEV1, FVC), blood pressure and blood biochemistry will be made. The participant will be asked to perform a short exercise test on a stationary bicycle to determine the bicycle workload for the main study.
Study visit On each visit, baseline measures will be taken at the CRF. The participant will be taken to a mobile facility to breathe in a set level of nanoparticles (target concentration of 200 micrograms per cubic metre) via a facemask for 2 hours while intermittently cycling. The mobile exposure chamber allows for volunteers to inhale specific air pollutants (typical of an urban environment), nanoparticles or gases at precise concentrations while exercising. Nanoparticles will be obtained as standard reference materials or by custom synthesis at the National Graphene Institute at the University of Manchester. All suspensions of nanoparticles are well characterised, free of contamination and have been extensively tested in preclinical models.
After the exposure the participant will return to the CRF and lung function and blood pressure re-measured. Blood will be withdrawn through a cannula in a large vein in the arm at set times after the exposure (15 min, 2h, 4h) for measurement of eicosanoids and other indicators of a haematological response (e.g. an inflammatory response). Blood will be slowly withdrawn (10 mL/min for 5 min) through a tube into a small piece of equipment called a Badimon Chamber which gives a measure of how readily the blood clots. The responsiveness of blood vessels in the arm will then be measured by a technique called forearm plethysmography. Here cuffs are inflated around the wrist and top of the arm and the blood flow is measured by a sensitive gauge around the forearm. Two different vasodilator drugs (acetylcholine and sodium nitroprusside) will be infused into an artery in the arm to see how the nanoparticle exposure has altered the way the blood vessels of the arm respond to these drugs. Blood will also be taken after each drug to measure substances that are release from the wall of arteries to give further indication of the health of the artery. The cannula will be removed and lung function and blood pressure will be re-measured. The participant will be allowed to rest, provided with food and drink, before leaving the hospital.
Biological samples (blood and urine) will be used to measure a range of cardiovascular parameters at the RIE and the University of Edinburgh. The primary endpoint for the study is the measurement of a panel of lipid mediators called eicosanoids, which will be performed by our collaborators at the University of Highlands and Islands who have specialised lipidomic facilities and experience in this area.
Shortened protocol An additional 12 volunteers will be recruited to perform a shortened version of the main protocol. The protocol is identical to the above with the exception that the forearm blood flow, Badimon study and the t=4 time point have been removed. These studies will be used to allow additional monitoring of the effect of nanoparticles during initial visits.
- Being tested
- diesel exhaust particulate, carbon nanoparticles, small graphene oxide, ultrasmall graphene oxide, filtered air
- Keywords
- nanoparticles, pollution
- Medical subject headings
- Aneurysm, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diesel exhaust particulateOther
Also called DEP, SRM2975
aerosolised diesel exhaust particulate
carbon nanoparticlesOther
Also called carbon black, CB, Printex 90
aerosolised 'clean' carbon nanoparticles
small graphene oxideOther
Also called s-GO
aerosolised 'small' graphene oxide
ultrasmall graphene oxideOther
Also called us-GO
aerosolised 'ultrasmall' graphene oxide
filtered airOther
Also called FA
control: filtered air
| Study group | Role | What they receive |
|---|---|---|
| Exposure 1 | Sham comparator | filtered air Receives: Other: filtered air |
| Exposure 2 | Experimental | nanoparticle 1 (either DEP or s-GO depending on group) Receives: Other: diesel exhaust particulate; Other: small graphene oxide |
| Exposure 3 | Experimental | nanoparticle 2 (either CB or us-GO depending on group) Receives: Other: carbon nanoparticles; Other: ultrasmall graphene oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood eicosanoid levels
Eicosanoids in blood (pg/mL)
Measured: Results available within 6 months of final study visit
Urine eicosanoid levels
Eicosanoids in urine (pg/mL)
Measured: Results available within 6 months of final study visit
Secondary outcomes (14)
blood pressure
systolic/diastolic blood pressure (mmHg/mmHg)
Measured: Results available immediately at time of measurement
Heart rate
Heart rate (bpm)
Measured: Results available immediately at time of measurement
Lung function (FEV1)
Forced expiratory volume (% predicted litres)
Measured: Results available immediately at time of measurement
Lung function (FVC)
Forced vital capacity (% predicted litres)
Measured: Results available immediately at time of measurement
Full blood count
Blood cell counts (cells/mL)
Measured: Results available within 3 months of study visit
Coagulation screen
Activated partial thromboplasmin time (seconds)
Measured: Results available within 3 months of study visit
Internal normailised ratio
blood INR (ratio, arbitrary units)
Measured: Results available within 3 months of study visit
C-reactive protein
Serum CRP levels (pg/mL)
Measured: Results available within 3 months of study visit
Tumour necrosis factor
Blood TNFa levels (pg/mL)
Measured: Results available within 6 months of study visit
Interleukin-6
Blood IL-6 levels (pg/mL)
Measured: Results available within 6 months of study visit
Blood coagulability (low-shear)
Area of thrombus on arterial strip from low sheer-stress Badimon chamber (micrometers squared)
Measured: Results available within 6 months of study visit
Blood coagulability (high-shear)
Area of thrombus on arterial strip from high sheer-stress Badimon chambers (micrometers squared)
Measured: Results available within 6 months of study visit
Vascular responsiveness (endothelium-dependent vasodilator)
Forearm blood flow to acetylcholine (mL blood/mL 100g tissue per min)
Measured: Results available within 1 year of study visit
Vascular responsiveness (endothelium-independent vasodilator)
Forearm blood flow to sodium nitroprusside (mL blood/mL 100g tissue per min)
Measured: Results available within 1 year of study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start3 Oct 2018
- Primary completion29 Mar 2019
- Study completion27 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood BiomarkersStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Cohort study with double blind randomised cross over design
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659864
- Sponsor's protocol ID
- AC18026
- Other IDs
- SP/15/8/31575
- Acronym
- ECOARM
- Status last verified
- May 2024
- First submitted
- 9 Aug 2018
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andrews JPM, Joshi SS, Tzolos E, Syed MB, Cuthbert H, Crica LE, Lozano N, Okwelogu E, Raftis JB, Bruce L, Poland CA, Duffin R, Fokkens PHB, Boere AJF, Leseman DLAC, Megson IL, Whitfield PD, Ziegler K, Tammireddy S, Hadjidemetriou M, Bussy C, Cassee FR, Newby DE, Kostarelos K, Miller MR. First-in-human controlled inhalation of thin graphene oxide nanosheets to study acute cardiorespiratory responses. Nat Nanotechnol. 2024 May;19(5):705-714. doi: 10.1038/s41565-023-01572-3. Epub 2024 Feb 16.
PubMed 38366225
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Eicosanoids in the Cardiovascular Actions of Inhaled Nanoparticles
- ClinicalTrials.gov ID
- NCT03659864
- Acronym / sponsor ID
- ECOARM / AC18026
- Keywords
- nanoparticles, pollution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- 3 Oct 2018 (actual)
- Primary completion
- 29 Mar 2019 (actual)
- Study completion
- 27 Nov 2020 (actual)
- First posted
- 6 Sep 2018 (actual)
- 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.
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.
Detailed description
This study will investigate the biological effects of inhaling different nanoparticles in healthy volunteers. We will compare 4 different types of nanoparticles: diesel exhaust nanoparticles (a nanoparticle with a complex mixture of chemicals), carbon black nanoparticles (a 'simple, clean' carbon nanoparticle) and two different sizes of graphene oxide (flat flakes of carbon), as well as inhalation of filtered air for comparison. Volunteers will be split randomly into 2 groups and each will be exposed to 3 nanoparticles, separately in a randomised order, with at least 2 weeks between the exposures (Cohort study with double blind randomised cross over design).
Screening visit 30 healthy non-smoking volunteers will be recruited. The volunteer will attend a screening visit at the Clinical Research Facility (CRF) at the Royal Infirmary of Edinburgh (RIE). Eligibility will be confirmed and consent taken. Baseline measurements of lung function (FEV1, FVC), blood pressure and blood biochemistry will be made. The participant will be asked to perform a short exercise test on a stationary bicycle to determine the bicycle workload for the main study.
Study visit On each visit, baseline measures will be taken at the CRF. The participant will be taken to a mobile facility to breathe in a set level of nanoparticles (target concentration of 200 micrograms per cubic metre) via a facemask for 2 hours while intermittently cycling. The mobile exposure chamber allows for volunteers to inhale specific air pollutants (typical of an urban environment), nanoparticles or gases at precise concentrations while exercising. Nanoparticles will be obtained as standard reference materials or by custom synthesis at the National Graphene Institute at the University of Manchester. All suspensions of nanoparticles are well characterised, free of contamination and have been extensively tested in preclinical models.
After the exposure the participant will return to the CRF and lung function and blood pressure re-measured. Blood will be withdrawn through a cannula in a large vein in the arm at set times after the exposure (15 min, 2h, 4h) for measurement of eicosanoids and other indicators of a haematological response (e.g. an inflammatory response). Blood will be slowly withdrawn (10 mL/min for 5 min) through a tube into a small piece of equipment called a Badimon Chamber which gives a measure of how readily the blood clots. The responsiveness of blood vessels in the arm will then be measured by a technique called forearm plethysmography. Here cuffs are inflated around the wrist and top of the arm and the blood flow is measured by a sensitive gauge around the forearm. Two different vasodilator drugs (acetylcholine and sodium nitroprusside) will be infused into an artery in the arm to see how the nanoparticle exposure has altered the way the blood vessels of the arm respond to these drugs. Blood will also be taken after each drug to measure substances that are release from the wall of arteries to give further indication of the health of the artery. The cannula will be removed and lung function and blood pressure will be re-measured. The participant will be allowed to rest, provided with food and drink, before leaving the hospital.
Biological samples (blood and urine) will be used to measure a range of cardiovascular parameters at the RIE and the University of Edinburgh. The primary endpoint for the study is the measurement of a panel of lipid mediators called eicosanoids, which will be performed by our collaborators at the University of Highlands and Islands who have specialised lipidomic facilities and experience in this area.
Shortened protocol An additional 12 volunteers will be recruited to perform a shortened version of the main protocol. The protocol is identical to the above with the exception that the forearm blood flow, Badimon study and the t=4 time point have been removed. These studies will be used to allow additional monitoring of the effect of nanoparticles during initial visits.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Cohort study with double blind randomised cross over design
| Arm | Type | Receives |
|---|---|---|
| Exposure 1 | Sham comparator | Other: filtered airfiltered air |
| Exposure 2 | Experimental | Other: diesel exhaust particulate, Other: small graphene oxidenanoparticle 1 (either DEP or s-GO depending on group) |
| Exposure 3 | Experimental | Other: carbon nanoparticles, Other: ultrasmall graphene oxidenanoparticle 2 (either CB or us-GO depending on group) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (10 listed)
- 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)
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 |
|---|---|---|
| diesel exhaust particulateAlso: DEP, SRM2975aerosolised diesel exhaust particulate | Other | Exposure 2 |
| carbon nanoparticlesAlso: carbon black, CB, Printex 90aerosolised 'clean' carbon nanoparticles | Other | Exposure 3 |
| small graphene oxideAlso: s-GOaerosolised 'small' graphene oxide | Other | Exposure 2 |
| ultrasmall graphene oxideAlso: us-GOaerosolised 'ultrasmall' graphene oxide | Other | Exposure 3 |
| filtered airAlso: FAcontrol: filtered air | Other | Exposure 1 |
Primary outcome
Blood eicosanoid levels
Time frame: Results available within 6 months of final study visit
Eicosanoids in blood (pg/mL)
Urine eicosanoid levels
Time frame: Results available within 6 months of final study visit
Eicosanoids in urine (pg/mL)
14 secondary outcomes
blood pressure
Time frame: Results available immediately at time of measurement
Heart rate
Time frame: Results available immediately at time of measurement
Lung function (FEV1)
Time frame: Results available immediately at time of measurement
Lung function (FVC)
Time frame: Results available immediately at time of measurement
Full blood count
Time frame: Results available within 3 months of study visit
Coagulation screen
Time frame: Results available within 3 months of study visit
Internal normailised ratio
Time frame: Results available within 3 months of study visit
C-reactive protein
Time frame: Results available within 3 months of study visit
Tumour necrosis factor
Time frame: Results available within 6 months of study visit
Interleukin-6
Time frame: Results available within 6 months of study visit
Blood coagulability (low-shear)
Time frame: Results available within 6 months of study visit
Blood coagulability (high-shear)
Time frame: Results available within 6 months of study visit
Vascular responsiveness (endothelium-dependent vasodilator)
Time frame: Results available within 1 year of study visit
Vascular responsiveness (endothelium-independent vasodilator)
Time frame: Results available within 1 year of study visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Derived from this study: PubMed 38366225Andrews JPM, Joshi SS, Tzolos E, Syed MB, Cuthbert H, Crica LE, Lozano N, Okwelogu E, Raftis JB, Bruce L, Poland CA, Duffin R, Fokkens PHB, Boere AJF, Leseman DLAC, Megson IL, Whitfield PD, Ziegler K, Tammireddy S, Hadjidemetriou M, Bussy C, Cassee FR, Newby DE, Kostarelos K, Miller MR. First-in-human controlled inhalation of thin graphene oxide nanosheets to study acute cardiorespiratory responses. Nat Nanotechnol. 2024 May;19(5):705-714. doi: 10.1038/s41565-023-01572-3. Epub 2024 Feb 16.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diesel exhaust particulate, carbon nanoparticles and small graphene oxide in people with Blood Biomarkers and Vasodilation, run by University of Edinburgh at 1 site in United Kingdom.
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 7 inclusion and 10 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: finished, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Blood eicosanoid levels (time frame: Results available within 6 months of final study visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03659864, which also lists 1 linked publication.
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 21 May 2024.