The Effect of Ischaemic-Reperfusion and Ischaemic Preconditioning on the Endogenous Fibrinolysis in Man
October 22, 2010 updated by: University of Edinburgh
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Edinburgh, United Kingdom, EH16 4SB
- University of Edinburgh, 49 Little France Crescent
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy males between 18-65 years of ages, non-smokers.
Exclusion Criteria:
- Any concurrent illness or chronic medical condition. Concurrent use of vasoactive medication. Smoking history.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
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.
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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.
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Active Comparator: 2
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.
|
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.
|
|
Placebo Comparator: 3
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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Net t-PA release from the endothelium after ischaemia reperfusion and ischaemic preconditioning
Time Frame: Throughout the study
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Throughout the study
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Change in forearm blood flow after ischaemia reperfusion and ischaemic preconditioning
Time Frame: throughout the study
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throughout the study
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Change in platelet-monocyte-binding after ischaemia reperfusion and ischaemic preconditioning
Time Frame: Throughout the study
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Throughout the study
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: David E Newby, PhD, FRCP, University of Edinburgh
- Study Director: Rajesh K Kharbanda, PhD, FRCP, University of Oxford
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Pedersen 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Actual)
October 1, 2010
Study Completion (Actual)
October 1, 2010
Study Registration Dates
First Submitted
November 10, 2008
First Submitted That Met QC Criteria
November 10, 2008
First Posted (Estimate)
November 11, 2008
Study Record Updates
Last Update Posted (Estimate)
October 25, 2010
Last Update Submitted That Met QC Criteria
October 22, 2010
Last Verified
October 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMP 2
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