Ischaemic Heart DiseasesNCT00789243
The Effect of Ischaemic-Reperfusion and Ischaemic Preconditioning on the Endogenous Fibrinolysis in Man
A study testing Forearm vascular study 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 at relieving this blockage as quickly as possible to minimise 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
- 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
- Nov 2008to 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 at relieving this blockage as quickly as possible to minimise 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 us 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
- Keywords
- Ischaemia reperfusion, t-PA, Fibrinolysis, Endothelial function, Local and remote ischaemic preconditioning
- 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 substance P (2,4,8 pmol/min). Venous blood sampling via cannula in antecubital fossa.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Prior to 20 mins of ischaemia induced by a blood pressure cuff inflated to 200 mmHg around the upper non-dominant arm, local ischaemic preconditioning will be induced by inflating a cuff around the non-dominant arm to 200 mmHg for 5 mins followed by 5 mins of reperfusion. This cycle will be repeated 3 times. Receives: Procedure: Forearm vascular study |
| 2 | Active comparator | Prior to 20 mins of ischaemia induced by a blood pressure cuff inflated to 200 mmHg around the upper non-dominant arm, remote ischaemic preconditioning will be induced by inflating a cuff around the dominant arm to 200 mmHg for 5 mins followed by 5 mins of reperfusion. This cycle will be repeated 3 times. Receives: Procedure: Forearm vascular study |
| 3 | Placebo comparator | Prior to 20 mins of ischaemia induced by a blood pressure cuff inflated to 200 mmHg around the upper non-dominant arm, sham will be performed by inflating a cuff to 10 mmHg for 5 mins followed by 5 mins of deflation. This cycle will be repeated 3 times. Receives: Procedure: Forearm vascular study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net t-PA release from the endothelium after ischaemia reperfusion and ischaemic preconditioning
Measured: Throughout the study
Secondary outcomes (2)
Change in forearm blood flow after ischaemia reperfusion and ischaemic preconditioning
Measured: throughout the study
Change in platelet-monocyte-binding after ischaemia reperfusion and ischaemic preconditioning
Measured: Throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2008 (estimated)
- Study startNov 2008
- 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 (2)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
- NCT00789243
- Sponsor's protocol ID
- CMP 2
- Status last verified
- Oct 2010
- First submitted
- 10 Nov 2008
- Last updated
- 25 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Pedersen CM, Barnes G, Schmidt MR, Botker HE, Kharbanda RK, Newby DE, Cruden NL. Ischaemia-reperfusion injury impairs tissue plasminogen activator release in man. Eur Heart J. 2012 Aug;33(15):1920-7. doi: 10.1093/eurheartj/ehr380. Epub 2011 Oct 11.
PubMed 21990263Pedersen CM, Cruden NL, Schmidt MR, Lau C, Botker HE, Kharbanda RK, Newby DE. Remote ischemic preconditioning prevents systemic platelet activation associated with ischemia-reperfusion injury in humans. J Thromb Haemost. 2011 Feb;9(2):404-7. doi: 10.1111/j.1538-7836.2010.04142.x. No abstract available.
PubMed 21083644
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 and Ischaemic Preconditioning on the Endogenous Fibrinolysis in Man
- ClinicalTrials.gov ID
- NCT00789243
- Acronym / sponsor ID
- CMP 2
- Conditions
- Ischaemic Heart Diseases
- Keywords
- Ischaemia reperfusion, t-PA, Fibrinolysis, Endothelial function, Local and remote ischaemic preconditioning
- 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
- Nov 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 11 Nov 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.
Heart attacks are usually caused by a blood clot blocking an artery supplying blood to the heart. Current treatments are designed at relieving this blockage as quickly as possible to minimise 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 us 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
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Forearm vascular studyPrior to 20 mins of ischaemia induced by a blood pressure cuff inflated to 200 mmHg around the upper non-dominant arm, local ischaemic preconditioning will be induced by inflating a cuff around the non-dominant arm to 200 mmHg for 5 mins followed by 5 mins of reperfusion. This cycle will be repeated 3 times. |
| 2 | Active comparator | Procedure: Forearm vascular studyPrior to 20 mins of ischaemia induced by a blood pressure cuff inflated to 200 mmHg around the upper non-dominant arm, remote ischaemic preconditioning will be induced by inflating a cuff around the dominant arm to 200 mmHg for 5 mins followed by 5 mins of reperfusion. This cycle will be repeated 3 times. |
| 3 | Placebo comparator | Procedure: Forearm vascular studyPrior to 20 mins of ischaemia induced by a blood pressure cuff inflated to 200 mmHg around the upper non-dominant arm, sham will be performed by inflating a cuff to 10 mmHg for 5 mins followed by 5 mins of deflation. This cycle will be repeated 3 times. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy males between 18-65 years of ages, non-smokers.
Key exclusion criteria (1 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 substance P (2,4,8 pmol/min). Venous blood sampling via cannula in antecubital fossa. | Procedure or surgery | 1, 2, 3 |
Primary outcome
Net t-PA release from the endothelium after ischaemia reperfusion and ischaemic preconditioning
Time frame: Throughout the study
2 secondary outcomes
Change in forearm blood flow after ischaemia reperfusion and ischaemic preconditioning
Time frame: throughout the study
Change in platelet-monocyte-binding after ischaemia reperfusion and ischaemic preconditioning
Time frame: Throughout the study
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 21990263Pedersen CM, Barnes G, Schmidt MR, Botker HE, Kharbanda RK, Newby DE, Cruden NL. Ischaemia-reperfusion injury impairs tissue plasminogen activator release in man. Eur Heart J. 2012 Aug;33(15):1920-7. doi: 10.1093/eurheartj/ehr380. Epub 2011 Oct 11.
- Derived from this study: PubMed 21083644Pedersen CM, Cruden NL, Schmidt MR, Lau C, Botker HE, Kharbanda RK, Newby DE. Remote ischemic preconditioning prevents systemic platelet activation associated with ischemia-reperfusion injury in humans. J Thromb Haemost. 2011 Feb;9(2):404-7. doi: 10.1111/j.1538-7836.2010.04142.x. No abstract available.
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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 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 1 inclusion and 1 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?
Net t-PA release from the endothelium after ischaemia reperfusion and ischaemic preconditioning (time frame: Throughout the study). 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 NCT00789243, which also lists 2 linked publications.
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.