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CompletedNCT00789243Updated Oct 25, 2010

The Effect of Ischaemic-Reperfusion and Ischaemic Preconditioning on the Endogenous Fibrinolysis in Man

An interventional study of Forearm vascular study in Ischaemic Heart Diseases, sponsored by University of Edinburgh. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-10-25.

Sponsored by University of Edinburgh · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Male
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Study 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. 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.

02

Conditions studied

  • Ischaemic Heart Diseases

Keywords

  • Ischaemia reperfusion
  • t-PA
  • Fibrinolysis
  • Endothelial function
  • Local and remote ischaemic preconditioning
03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's planned enrollment of 12 is below the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

University of Edinburgh is the lead sponsor of 393 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy males between 18-65 years of ages, non-smokers.

Exclusion criteria

Exclusion Criteria:

  • Any concurrent illness or chronic medical condition. Concurrent use of vasoactive medication. Smoking history.
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
12 participants (estimated)

Study arms

  • 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.

    Procedure: Forearm vascular study

  • 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.

    Procedure: Forearm vascular study

  • 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.

    Procedure: Forearm vascular study

Interventions

  • ProcedureForearm vascular study

    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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What researchers measure

Primary outcomes

  1. Net t-PA release from the endothelium after ischaemia reperfusion and ischaemic preconditioning

    Time frame: Throughout the study

Secondary outcomes

  1. Change in forearm blood flow after ischaemia reperfusion and ischaemic preconditioning

    Time frame: throughout the study

  2. Change in platelet-monocyte-binding after ischaemia reperfusion and ischaemic preconditioning

    Time frame: Throughout the study

07

Study locations

1 site
  • University of Edinburgh, 49 Little France Crescent
    Edinburgh, EH16 4SB, United Kingdom
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References and documents

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 21990263 ↗
  • 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. PubMed 21083644 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00789243
Lead sponsor
University of Edinburgh
Collaborators
University of Aarhus, University of Oxford
First posted
Nov 11, 2008
Start date
Nov 2008
Primary completion
Oct 2010
Completion
Oct 2010
Last update
Oct 25, 2010

Study contacts

David E Newby, PhD, FRCP
study director · University of Edinburgh
Rajesh K Kharbanda, PhD, FRCP
study director · University of Oxford

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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