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OpenTrials
Completed

NCT Number: NCT00965120

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

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.

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Key information

Conditions

Ischaemic Heart Diseases Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Edinburgh, 49 Little France Crescent

Edinburgh, EH16 4SB, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Forearm Vascular Study

Procedure

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).

Primary outcomes

  1. Change in forearm blood flow in response to vasodilators (ACh) and ischaemia reperfusion

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

Secondary outcomes

  1. Change in platelet-monocyte-binding after ischaemia reperfusion

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

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • University of Aarhus
  • University of Oxford

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 25, 2009
Registry last updated
Oct 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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