Vascular FunctionFIREPROOFNCT01812317
Effect of Real-fire Training on Vascular Function
A study testing Forearm Vascular Study and Badimon Chamber Study in people with Vascular Function and Atherothrombosis, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
Fire-fighters are at increased risk of death from heart attacks when compared to other emergency service professionals whose jobs involve similar components such as emergency call-outs and shift work. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Vascular Function, Atherothrombosis
- What is being tested?
- Forearm Vascular Study and Badimon Chamber Study
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2012to Sep 2016
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoking healthy firefighters
Who cannot join
- Current smoker
- History of lung or ischaemic heart disease
- Malignant arrhythmia
- Systolic blood pressure >190mmHg or <100mmHg
- Renal or hepatic dysfunction
- Previous history of blood dyscrasia
Show all 10Show fewer
- Unable to tolerate the supine position
- Blood donation within the last 3 months
- Recent respiratory tract infection within the past 4 weeks
- Routine medication including aspirin and NSAIDs
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Infirmary of Edinburgh Clinical Research Facility
Edinburgh, EH16 4SA
About this study
Fire-fighters are at increased risk of death from heart attacks when compared to other emergency service professionals whose jobs involve similar components such as emergency call-outs and shift work. The unique risk to fire-fighters is likely to reflect a combination of factors including extreme physical exertion, mental stress, heat and pollutant exposure.
In the largest analysis of cause of death amongst on-duty fire-fighters, fire-fighter deaths were classified according to the duty performed during the onset of symptoms or immediately prior to any sudden death. The majority of deaths due to a cardiovascular cause (i.e. heart attack) occurred during fire-suppression whilst this activity represented a relatively small amount of a fire-fighters professional time. Fire simulation training centers offer a unique opportunity to assess the heart, blood and blood vessel response to fire suppression in a controlled environment.
In this study the investigators will assess healthy career fire-fighters on two occasions: following a fire-suppression training exercise in a purpose built real-fire training center, and following a sedentary period as a control. The investigators will take blood samples to measure platelet activity (platelets are the particles in blood that help blood clot) and will examine how blood clots outside of the body. The investigators will then perform studies placing small needles in the arm to assess blood vessel function following fire suppression. By undertaking this comprehensive assessment of blood, blood vessel and heart function we hope to understand the mechanisms whereby the risk of a heart attack is influenced by fire suppression. The investigators hypothesize that following the fire-suppression exercise firefighters blood will clot more readily and their blood vessels will not relax properly which are two of the main processes in the development of a heart attack.
- Conditions
- Vascular Function, Atherothrombosis
- Being tested
- Forearm Vascular Study, Badimon Chamber Study
- Keywords
- firefighters, fire-simulation training, myocardial infarction, endothelial function, thrombosis
- Medical subject headings
- Thrombosis, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forearm Vascular StudyProcedure or surgery
Also called BK, SNP, ACh, VP
Forearm venous occlusion plethysmography to measure forearm blood flow during intra-arterial infusion of the vasodilators Verapamil (10-100 µg/min), bradykinin (100-1000 pmol/min), sodium nitroprusside (2-8 µg/min) and Acetylcholine (5-20 µg/min).
Badimon Chamber StudyProcedure or surgery
Ex-vivo assessment of thrombus formation using the Badimon Chamber
| Study group | Role | What they receive |
|---|---|---|
| Real-fire training exercise | Active comparator | Subjects will undergo a 20 minute standardised training exercise in a fire simulation facility. Receives: Procedure: Forearm Vascular Study; Procedure: Badimon Chamber Study |
| Sedentary training session | Sham comparator | Subjects will undergo a training exercise where they will remain sedentary for 20 mins in an ambient temperature. Receives: Procedure: Forearm Vascular Study; Procedure: Badimon Chamber Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forearm blood flow measured by venous occlusion plethysmography in response to infused vasodilators
Measured: 3-6 hours post exposure
Secondary outcomes (2)
Ex-vivo thrombus formation using the Badimon chamber
Measured: 2 hours post exposure
Plasma t-PA and PAI concentrations following infusion of bradykinin
Measured: During forearm study, 3-6 hours post exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study startApr 2012
- Primary completionSep 2016
- Study completionSep 2016
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 Vascular FunctionStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David E Newby, MD PhD, Study chair, University of EdinburghNicholas L Mills, MBChB PhD, Study director, University of EdinburghAmanda L Hunter, MBChB, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01812317
- Sponsor's protocol ID
- 11-SS-0086
- Other IDs
- PG/11/27/28842
- Acronym
- FIREPROOF
- Status last verified
- Jun 2021
- First submitted
- 4 Mar 2013
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hunter AL, Shah AS, Langrish JP, Raftis JB, Lucking AJ, Brittan M, Venkatasubramanian S, Stables CL, Stelzle D, Marshall J, Graveling R, Flapan AD, Newby DE, Mills NL. Fire Simulation and Cardiovascular Health in Firefighters. Circulation. 2017 Apr 4;135(14):1284-1295. doi: 10.1161/CIRCULATIONAHA.116.025711.
PubMed 28373523
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Real-fire Training on Vascular Function
- ClinicalTrials.gov ID
- NCT01812317
- Acronym / sponsor ID
- FIREPROOF / 11-SS-0086
- Conditions
- Vascular Function, Atherothrombosis
- Keywords
- firefighters, fire-simulation training, myocardial infarction, endothelial function, thrombosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- Apr 2012 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 18 Mar 2013 (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.
Fire-fighters are at increased risk of death from heart attacks when compared to other emergency service professionals whose jobs involve similar components such as emergency call-outs and shift work. The unique risk to fire-fighters is likely to reflect a combination of factors including extreme physical exertion, mental stress, heat and pollutant exposure.
In the largest analysis of cause of death amongst on-duty fire-fighters, fire-fighter deaths were classified according to the duty performed during the onset of symptoms or immediately prior to any sudden death. The majority of deaths due to a cardiovascular cause (i.e. heart attack) occurred during fire-suppression whilst this activity represented a relatively small amount of a fire-fighters professional time. Fire simulation training centers offer a unique opportunity to assess the heart, blood and blood vessel response to fire suppression in a controlled environment.
In this study the investigators will assess healthy career fire-fighters on two occasions: following a fire-suppression training exercise in a purpose built real-fire training center, and following a sedentary period as a control. The investigators will take blood samples to measure platelet activity (platelets are the particles in blood that help blood clot) and will examine how blood clots outside of the body. The investigators will then perform studies placing small needles in the arm to assess blood vessel function following fire suppression. By undertaking this comprehensive assessment of blood, blood vessel and heart function we hope to understand the mechanisms whereby the risk of a heart attack is influenced by fire suppression. The investigators hypothesize that following the fire-suppression exercise firefighters blood will clot more readily and their blood vessels will not relax properly which are two of the main processes in the development of a heart attack.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real-fire training exercise | Active comparator | Procedure: Forearm Vascular Study, Procedure: Badimon Chamber StudySubjects will undergo a 20 minute standardised training exercise in a fire simulation facility. |
| Sedentary training session | Sham comparator | Procedure: Forearm Vascular Study, Procedure: Badimon Chamber StudySubjects will undergo a training exercise where they will remain sedentary for 20 mins in an ambient temperature. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Non-smoking healthy firefighters
Key exclusion criteria (10 listed)
- Current smoker
- History of lung or ischaemic heart disease
- Malignant arrhythmia
- Systolic blood pressure >190mmHg or <100mmHg
- Renal or hepatic dysfunction
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 Vascular StudyAlso: BK, SNP, ACh, VPForearm venous occlusion plethysmography to measure forearm blood flow during intra-arterial infusion of the vasodilators Verapamil (10-100 µg/min), bradykinin (100-1000 pmol/min), sodium nitroprusside (2-8 µg/min) and Acetylcholine (5-20 µg/min). | Procedure or surgery | Real-fire training exercise, Sedentary training session |
| Badimon Chamber StudyEx-vivo assessment of thrombus formation using the Badimon Chamber | Procedure or surgery | Real-fire training exercise, Sedentary training session |
Primary outcome
Forearm blood flow measured by venous occlusion plethysmography in response to infused vasodilators
Time frame: 3-6 hours post exposure
2 secondary outcomes
Ex-vivo thrombus formation using the Badimon chamber
Time frame: 2 hours post exposure
Plasma t-PA and PAI concentrations following infusion of bradykinin
Time frame: During forearm study, 3-6 hours post exposure
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 Jun 2021.
- Results publication: PubMed 28373523Hunter AL, Shah AS, Langrish JP, Raftis JB, Lucking AJ, Brittan M, Venkatasubramanian S, Stables CL, Stelzle D, Marshall J, Graveling R, Flapan AD, Newby DE, Mills NL. Fire Simulation and Cardiovascular Health in Firefighters. Circulation. 2017 Apr 4;135(14):1284-1295. doi: 10.1161/CIRCULATIONAHA.116.025711.
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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.
David E Newby, MD PhD study chair
University of Edinburgh
Nicholas L Mills, MBChB PhD study director
University of Edinburgh
Amanda L Hunter, MBChB principal investigator
University of Edinburgh
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 Vascular Study and Badimon Chamber Study in people with Vascular Function and Atherothrombosis, 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 1 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 Jun 2021. 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?
Forearm blood flow measured by venous occlusion plethysmography in response to infused vasodilators (time frame: 3-6 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 NCT01812317, 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 Jun 2021.