Ischaemic Heart DiseasesNCT00965120
The Effect of Ischaemic-Reperfusion in Man - A Bradykinin Dependent Pathway
A study testing Forearm vascular study and bradykinin receptor antagonist (HOE-140) in people with Ischaemic Heart Diseases, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
Heart attacks are usually caused by a blood clot blocking an artery supplying blood to the heart. Current treatments are designed to relieve this blockage as quickly as possible to minimize damage to the heart muscle. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ischaemic Heart Diseases
- What is being tested?
- Forearm vascular study and bradykinin receptor antagonist (HOE-140)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2009to Oct 2010
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy males between 18-65 years of ages
- non-smokers
Who cannot join
- any concurrent illness or chronic medical condition
- concurrent use of vasoactive medication
- smoking history
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Edinburgh, 49 Little France Crescent
Edinburgh, EH16 4SB
About this study
Heart attacks are usually caused by a blood clot blocking an artery supplying blood to the heart. Current treatments are designed to relieve this blockage as quickly as possible to minimize damage to the heart muscle. However in restoring the supply of blood local damage known as "ischaemia-reperfusion injury" may occur. The aim of this study is to assess how clot forming and clot dissolving pathways are affected during this process, and examine the role of a natural inflammatory hormone, bradykinin. This will help the investigators to understand the mechanism by which ischaemia-reperfusion injury may occur and to devise new treatments for heart attacks.
- Conditions
- Ischaemic Heart Diseases
- Being tested
- Forearm vascular study, bradykinin receptor antagonist (HOE-140), Placebo (saline)
- Keywords
- Ischaemia reperfusion, Bradykinin, Platelet activation, Endothelial function
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forearm vascular studyProcedure or surgery
Forearm blood flow measured by venous occlusion plethysmography during interarterial infusion of vasodilators (Ach). Venous blood sampling via cannula in antecubital fossa.
bradykinin receptor antagonist (HOE-140)Drug
Systemic infusion of bradykinin receptor antagonist (HOE-140).
Placebo (saline)Drug
Systemic infusion of placebo (saline).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Ischaemia 20 minutes. Blood pressure cuff will be inflated to 200mmHg around the upper arm for 20 minutes to induce ischaemia. Systemic infusion of placebo (saline). Receives: Procedure: Forearm vascular study; Drug: Placebo (saline) |
| 2 | Active comparator | Ischaemia 20 minutes. Blood pressure cuff will be inflated to 200mmHg around the upper arm for 20 minutes to induce ischaemia. Systemic infusion of bradykinin receptor antagonist (HOE-140). Receives: Procedure: Forearm vascular study; Drug: bradykinin receptor antagonist (HOE-140) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in forearm blood flow in response to vasodilators (ACh) and ischaemia reperfusion
Measured: 20 fixed timepoints during each study visit (3hrs)
Secondary outcomes (1)
Change in platelet-monocyte-binding after ischaemia reperfusion
Measured: 4 fixed timepoints during each study visit (3hrs)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionOct 2010
- Study completionOct 2010
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 Ischaemic Heart DiseasesStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus, University of Oxford
- Investigators
- David E Newby, PhD, FRCP, Study director, University of EdinburghRajesh K Kharbanda, PhD, FRCP, Study director, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00965120
- Sponsor's protocol ID
- CMP 3
- Status last verified
- Oct 2010
- First submitted
- 21 Aug 2009
- Last updated
- 25 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Pedersen CM, Schmidt MR, Barnes G, Botker HE, Kharbanda RK, Newby DE, Cruden NL. Bradykinin does not mediate remote ischaemic preconditioning or ischaemia-reperfusion injury in vivo in man. Heart. 2011 Nov;97(22):1857-61. doi: 10.1136/heartjnl-2011-300323. Epub 2011 Aug 26.
PubMed 21873443
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ischaemic-Reperfusion in Man - A Bradykinin Dependent Pathway
- ClinicalTrials.gov ID
- NCT00965120
- Acronym / sponsor ID
- CMP 3
- Conditions
- Ischaemic Heart Diseases
- Keywords
- Ischaemia reperfusion, Bradykinin, Platelet activation, Endothelial function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- University of Aarhus, University of Oxford
- Study start
- Aug 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 25 Aug 2009 (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.
Heart attacks are usually caused by a blood clot blocking an artery supplying blood to the heart. Current treatments are designed to relieve this blockage as quickly as possible to minimize damage to the heart muscle. However in restoring the supply of blood local damage known as "ischaemia-reperfusion injury" may occur. The aim of this study is to assess how clot forming and clot dissolving pathways are affected during this process, and examine the role of a natural inflammatory hormone, bradykinin. This will help the investigators to understand the mechanism by which ischaemia-reperfusion injury may occur and to devise new treatments for heart attacks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Procedure: Forearm vascular study, Drug: Placebo (saline)Ischaemia 20 minutes. Blood pressure cuff will be inflated to 200mmHg around the upper arm for 20 minutes to induce ischaemia. Systemic infusion of placebo (saline). |
| 2 | Active comparator | Procedure: Forearm vascular study, Drug: bradykinin receptor antagonist (HOE-140)Ischaemia 20 minutes. Blood pressure cuff will be inflated to 200mmHg around the upper arm for 20 minutes to induce ischaemia. Systemic infusion of bradykinin receptor antagonist (HOE-140). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy males between 18-65 years of ages
- non-smokers
Key exclusion criteria (3 listed)
- any concurrent illness or chronic medical condition
- concurrent use of vasoactive medication
- smoking history
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 studyForearm blood flow measured by venous occlusion plethysmography during interarterial infusion of vasodilators (Ach). Venous blood sampling via cannula in antecubital fossa. | Procedure or surgery | 1, 2 |
| bradykinin receptor antagonist (HOE-140)Systemic infusion of bradykinin receptor antagonist (HOE-140). | Drug | 2 |
| Placebo (saline)Systemic infusion of placebo (saline). | Drug | 1 |
Primary outcome
Change in forearm blood flow in response to vasodilators (ACh) and ischaemia reperfusion
Time frame: 20 fixed timepoints during each study visit (3hrs)
1 secondary outcome
Change in platelet-monocyte-binding after ischaemia reperfusion
Time frame: 4 fixed timepoints during each study visit (3hrs)
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 25 Oct 2010.
- Derived from this study: PubMed 21873443Pedersen CM, Schmidt MR, Barnes G, Botker HE, Kharbanda RK, Newby DE, Cruden NL. Bradykinin does not mediate remote ischaemic preconditioning or ischaemia-reperfusion injury in vivo in man. Heart. 2011 Nov;97(22):1857-61. doi: 10.1136/heartjnl-2011-300323. Epub 2011 Aug 26.
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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, PhD, FRCP study director
University of Edinburgh
Rajesh K Kharbanda, PhD, FRCP study director
University of Oxford
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 bradykinin receptor antagonist (HOE-140) in people with Ischaemic Heart Diseases, 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 2 inclusion and 3 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 25 Oct 2010. 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?
Change in forearm blood flow in response to vasodilators (ACh) and ischaemia reperfusion (time frame: 20 fixed timepoints during each study visit (3hrs)). 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 NCT00965120, 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 25 Oct 2010.