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

October 22, 2010 updated by: University of Edinburgh
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
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).
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: Placebo (saline)
Systemic infusion of placebo (saline).
Active Comparator: 2
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).
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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in platelet-monocyte-binding after ischaemia reperfusion
Time Frame: 4 fixed timepoints during each study visit (3hrs)
4 fixed timepoints during each study visit (3hrs)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Collaborators

University of Aarhus
University of Oxford

Investigators

  • Study Director: David E Newby, PhD, FRCP, University of Edinburgh
  • Study Director: Rajesh K Kharbanda, PhD, FRCP, University of Oxford

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

August 21, 2009

First Submitted That Met QC Criteria

August 24, 2009

First Posted (Estimate)

August 25, 2009

Study Record Updates

Last Update Posted (Estimate)

October 25, 2010

Last Update Submitted That Met QC Criteria

October 22, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMP 3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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