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CompletedNCT00965393Updated Oct 25, 2010

The Effect of Ischaemic-Reperfusion and Remote Ischaemic Preconditioning in Man - A Bradykinin Dependent Pathway

An interventional study of Forearm vascular study and Placebo 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
01

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 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.

02

Conditions studied

  • Ischaemic Heart Diseases

Keywords

  • Ischaemia reperfusion
  • Platelet activation
  • Endothelial function
  • Remote ischaemic preconditioning
  • Bradykinin
03

In context

Coronary Artery Disease

5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.

This study's planned enrollment of 12 is below the median of 123 across 3,481 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

University of Edinburgh is the lead sponsor of 403 studies on the registry; 65 are open to participants now.

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

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.
05

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

  • Placebo comparator
    1

    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. Systemic infusion of placebo (saline).

    Procedure: Forearm vascular study · Drug: Placebo

  • 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. Systemic infusion of bradykinin receptor antagonist (HOE-140).

    Procedure: Forearm vascular study · Drug: bradykinin receptor antagonist (HOE-140)

Interventions

  • ProcedureForearm vascular study

    Forearm blood flow measured by venous occlusion plethysmography during interarterial infusion of vasodilators (Ach). Venous blood sampling via cannula in antecubital fossa.

  • DrugPlacebo

    Systemic infusion of placebo (saline)

  • Systemic infusion of bradykinin receptor antagonist (HOE-140)

06

What researchers measure

Primary outcomes

  1. Change in forearm blood flow in response to vasodilators (ACh(, ischaemia reperfusion and ischaemic preconditioning

    Time frame: 20 fixed timepoints during each study visit (3hrs)

Secondary outcomes

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

    Time frame: 4 fixed timepoints during each study visit (3hrs)

07

Study locations

1 site
  • University of Edinburgh, 49 Little France Crescent
    Edinburgh, EH16 4SB, United Kingdom
08

References and documents

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 ↗
09

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 ↗
10

Registry details

Key details

Study ID
NCT00965393
First posted
Aug 25, 2009
Start date
Aug 2009
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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