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

Ischaemic Heart Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00965120
• Other study ID #: CMP 3
• Status: Completed
• Phase: N/A
• First received: August 21, 2009
• Last updated: October 22, 2010
• Start date: August 2009
• Est. completion date: October 2010

Study information

• Verified date: October 2010
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Coronary Artery Disease
• Ischaemic Heart Diseases
• Ischemia
• Myocardial Ischemia

Intervention

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

Drug:
• bradykinin receptor antagonist (HOE-140)
Systemic infusion of bradykinin receptor antagonist (HOE-140).
• Placebo (saline)
Systemic infusion of placebo (saline).

Locations

Country	Name	City	State
United Kingdom	University of Edinburgh, 49 Little France Crescent	Edinburgh

Sponsors (3)

Lead Sponsor	Collaborator
University of Edinburgh	University of Aarhus, University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in forearm blood flow in response to vasodilators (ACh) and ischaemia reperfusion		20 fixed timepoints during each study visit (3hrs)	No
Secondary	Change in platelet-monocyte-binding after ischaemia reperfusion		4 fixed timepoints during each study visit (3hrs)	No