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

Primary Purpose

Ischaemic Heart Diseases

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Forearm vascular study

bradykinin receptor antagonist (HOE-140)

Placebo (saline)

About this trial

This is an interventional basic science trial for Ischaemic Heart Diseases focused on measuring Ischaemia reperfusion, Bradykinin, Platelet activation, Endothelial function

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

University of Edinburgh, 49 Little France Crescent

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in platelet-monocyte-binding after ischaemia reperfusion

Full Information

NCT ID

NCT00965120

First Posted

August 21, 2009

Last Updated

October 22, 2010

Sponsor

University of Edinburgh

Collaborators

University of Aarhus, University of Oxford

1. Study Identification

Unique Protocol Identification Number

NCT00965120

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2010

Overall Recruitment Status

Completed

Study Start Date

August 2009 (undefined)

Primary Completion Date

October 2010 (Actual)

Study Completion Date

October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Edinburgh

Collaborators

University of Aarhus, University of Oxford

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischaemic Heart Diseases

Keywords

Ischaemia reperfusion, Bradykinin, Platelet activation, Endothelial function

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Description

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).

Arm Title

Arm Type

Active Comparator

Arm Description

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).

Intervention Type

Procedure

Intervention Name(s)

Forearm vascular study

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

bradykinin receptor antagonist (HOE-140)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo (saline)

Intervention Description

Systemic infusion of placebo (saline).

Primary Outcome Measure Information:

Title

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

Time Frame

20 fixed timepoints during each study visit (3hrs)

Secondary Outcome Measure Information:

Title

Change in platelet-monocyte-binding after ischaemia reperfusion

Time Frame

4 fixed timepoints during each study visit (3hrs)

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David E Newby, PhD, FRCP

Organizational Affiliation

University of Edinburgh

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Rajesh K Kharbanda, PhD, FRCP

Organizational Affiliation

University of Oxford

Official's Role

Study Director

Facility Information:

Facility Name

University of Edinburgh, 49 Little France Crescent

City

Edinburgh

ZIP/Postal Code

EH16 4SB

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

21873443

Citation

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.

Results Reference

derived

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

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