Heart DiseaseNCT00745446
The Effect of a Retrofit Particle Trap on the Vascular Effects of Diesel Exhaust Inhalation
A study testing Forearm Venous Occlusion Plethysmography in people with Heart Disease, run by University of Edinburgh at 1 site in Sweden.
Trial summary
The purpose of this study is to determine whether a retrofit particle trap can reduce the adverse vascular responses to diesel exhaust inhalation Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Heart Disease
- What is being tested?
- Forearm Venous Occlusion Plethysmography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2007to Feb 2008
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers
Who cannot join
- Intercurrent illness
- Smoking
- Significant occupational exposure to air pollution
- Regular medication usage
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether a retrofit particle trap can reduce the adverse vascular responses to diesel exhaust inhalation
Read the detailed description
18 subjects healthy male volunteers will be recruited at Umeå University. In a randomised, double blind 3 way crossover trial, subjects will be exposed to filtered air, diesel exhaust (300mcg/m3) or filtered diesel exhaust for 1 hour during intermittent exercise.
2 hours following the exposure, thrombogenicity will be assessed using the Badimon chamber - an ex-vivo model of thrombosis formed under constant flow conditions.
Forearm blood flow in response to infused intra-brachial vasodilators will be measured using venous occlusion plethysmography 6 hours after the exposure.
Arterial stiffness will be measured using peripheral arterial applanation tonometry in the hour post-exposure.
Blood samples will be collected at timepoints over the 24 hours after exposure.
- Conditions
- Heart Disease
- Being tested
- Forearm Venous Occlusion Plethysmography
- Keywords
- Air pollution, Diesel exhaust, Endothelial function, Vascular function, Particle trap, Thrombosis, effects, inhalation
- Medical subject headings
- Heart Diseases, Thrombosis, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forearm Venous Occlusion PlethysmographyProcedure or surgery
Forearm venous occlusion plethysmography with intra-arterial infusion of Acetylcholine (5-20mcg/min), bradykinin (30-300mcg/min), sodium nitroprusside (2-8mcg/min) and Verapamil (2-10 mcg/min) into non-dominant brachial artery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 1 hour exposure to filtered air Receives: Procedure: Forearm Venous Occlusion Plethysmography |
| 2 | Experimental | 1 hour exposure to diesel exhaust (300mcg/m3) Receives: Procedure: Forearm Venous Occlusion Plethysmography |
| 3 | Experimental | 1 hour exposure to filtered diesel exhaust Receives: Procedure: Forearm Venous Occlusion Plethysmography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forearm blood flow in response to infused intra-arterial vasodilators
Measured: 6 hours post-exposure
Secondary outcomes (5)
Arterial stiffness measured by applanation tonometry
Measured: In the 1 hour following exposure
Thrombogenicity measured using the Badimon chamber - an ex-vivo model of thrombosis under conditions of continuous flow
Measured: 2 hours after the exposure
Exhaled nitric oxide - a marker of pulmonary inflammation
Measured: 1 hour & 6 hours after exposure
Endogenous fibrinolytic capacity - measured as net release of t-PA in response to infused bradykinin
Measured: 6 hours after exposure
Biochemical markers of systemic inflammation
Measured: Baseline, 2, 6 & 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startSep 2007
- Primary completionFeb 2008
- Study completionFeb 2008
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 Heart DiseaseStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Umeå University
- Investigators
- Anders Blomberg, MD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00745446
- Sponsor's protocol ID
- VOLVO 3ARM
- Status last verified
- Sep 2008
- First submitted
- 2 Sep 2008
- Last updated
- 5 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Lucking AJ, Lundback M, Barath SL, Mills NL, Sidhu MK, Langrish JP, Boon NA, Pourazar J, Badimon JJ, Gerlofs-Nijland ME, Cassee FR, Boman C, Donaldson K, Sandstrom T, Newby DE, Blomberg A. Particle traps prevent adverse vascular and prothrombotic effects of diesel engine exhaust inhalation in men. Circulation. 2011 Apr 26;123(16):1721-8. doi: 10.1161/CIRCULATIONAHA.110.987263. Epub 2011 Apr 11.
PubMed 21482966
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Retrofit Particle Trap on the Vascular Effects of Diesel Exhaust Inhalation
- ClinicalTrials.gov ID
- NCT00745446
- Acronym / sponsor ID
- VOLVO 3ARM
- Conditions
- Heart Disease
- Keywords
- Air pollution, Diesel exhaust, Endothelial function, Vascular function, Particle trap, Thrombosis, effects, inhalation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- Umeå University
- Study start
- Sep 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 3 Sep 2008 (estimated)
- 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.
The purpose of this study is to determine whether a retrofit particle trap can reduce the adverse vascular responses to diesel exhaust inhalation
Detailed description
18 subjects healthy male volunteers will be recruited at Umeå University. In a randomised, double blind 3 way crossover trial, subjects will be exposed to filtered air, diesel exhaust (300mcg/m3) or filtered diesel exhaust for 1 hour during intermittent exercise.
2 hours following the exposure, thrombogenicity will be assessed using the Badimon chamber - an ex-vivo model of thrombosis formed under constant flow conditions.
Forearm blood flow in response to infused intra-brachial vasodilators will be measured using venous occlusion plethysmography 6 hours after the exposure.
Arterial stiffness will be measured using peripheral arterial applanation tonometry in the hour post-exposure.
Blood samples will be collected at timepoints over the 24 hours after exposure.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Forearm Venous Occlusion Plethysmography1 hour exposure to filtered air |
| 2 | Experimental | Procedure: Forearm Venous Occlusion Plethysmography1 hour exposure to diesel exhaust (300mcg/m3) |
| 3 | Experimental | Procedure: Forearm Venous Occlusion Plethysmography1 hour exposure to filtered diesel exhaust |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male volunteers
Key exclusion criteria (4 listed)
- Intercurrent illness
- Smoking
- Significant occupational exposure to air pollution
- Regular medication usage
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 |
|---|---|---|
| Forearm Venous Occlusion PlethysmographyForearm venous occlusion plethysmography with intra-arterial infusion of Acetylcholine (5-20mcg/min), bradykinin (30-300mcg/min), sodium nitroprusside (2-8mcg/min) and Verapamil (2-10 mcg/min) into non-dominant brachial artery | Procedure or surgery | 1, 2, 3 |
Primary outcome
Forearm blood flow in response to infused intra-arterial vasodilators
Time frame: 6 hours post-exposure
5 secondary outcomes
Arterial stiffness measured by applanation tonometry
Time frame: In the 1 hour following exposure
Thrombogenicity measured using the Badimon chamber - an ex-vivo model of thrombosis under conditions of continuous flow
Time frame: 2 hours after the exposure
Exhaled nitric oxide - a marker of pulmonary inflammation
Time frame: 1 hour & 6 hours after exposure
Endogenous fibrinolytic capacity - measured as net release of t-PA in response to infused bradykinin
Time frame: 6 hours after exposure
Biochemical markers of systemic inflammation
Time frame: Baseline, 2, 6 & 24 hours
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 5 Sep 2008.
- Derived from this study: PubMed 21482966Lucking AJ, Lundback M, Barath SL, Mills NL, Sidhu MK, Langrish JP, Boon NA, Pourazar J, Badimon JJ, Gerlofs-Nijland ME, Cassee FR, Boman C, Donaldson K, Sandstrom T, Newby DE, Blomberg A. Particle traps prevent adverse vascular and prothrombotic effects of diesel engine exhaust inhalation in men. Circulation. 2011 Apr 26;123(16):1721-8. doi: 10.1161/CIRCULATIONAHA.110.987263. Epub 2011 Apr 11.
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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.
Anders Blomberg, MD principal investigator
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forearm Venous Occlusion Plethysmography in people with Heart Disease, run by University of Edinburgh at 1 site in Sweden.
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 1 inclusion and 4 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 5 Sep 2008. 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 Sweden. 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. 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?
Forearm blood flow in response to infused intra-arterial vasodilators (time frame: 6 hours post-exposure). 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 NCT00745446, 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 5 Sep 2008.