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

Not Applicable

Completed

• Conditions: Ischaemic Heart Diseases
• Interventions: Procedure: Forearm vascular study; Drug: bradykinin receptor antagonist (HOE-140); Drug: Placebo (saline)

• Registration Number: NCT00965120
• Lead Sponsor: University of Edinburgh

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-21
• Study First Submitted QC: 2009-08-24
• Study First Posted: 2009-08-25
• Status Verified: 2010-10
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Last Update Submitted: 2010-10-22
• Last Update Posted: 2010-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	bradykinin receptor antagonist (HOE-140)	Ischaemia 20 minutes. Blood pressure cuff will be inflated to 200mmHg around the upper arm for 20 minutes to induce ischaemia. Systemic infusion of bradykinin receptor antagonist (HOE-140).
1	Forearm vascular study	Ischaemia 20 minutes. Blood pressure cuff will be inflated to 200mmHg around the upper arm for 20 minutes to induce ischaemia. Systemic infusion of placebo (saline).
1	Placebo (saline)	Ischaemia 20 minutes. Blood pressure cuff will be inflated to 200mmHg around the upper arm for 20 minutes to induce ischaemia. Systemic infusion of placebo (saline).
2	Forearm vascular study	Ischaemia 20 minutes. Blood pressure cuff will be inflated to 200mmHg around the upper arm for 20 minutes to induce ischaemia. Systemic infusion of bradykinin receptor antagonist (HOE-140).

Primary Outcome Measures

Name	Time	Method
Change in forearm blood flow in response to vasodilators (ACh) and ischaemia reperfusion	20 fixed timepoints during each study visit (3hrs)

Secondary Outcome Measures

Name	Time	Method
Change in platelet-monocyte-binding after ischaemia reperfusion	4 fixed timepoints during each study visit (3hrs)

Trial Locations

Locations (1)

University of Edinburgh, 49 Little France Crescent; 🇬🇧 Edinburgh, United Kingdom