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The Effect of Ischaemic-Reperfusion and Remote Ischaemic Preconditioning 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
Placebo
bradykinin receptor antagonist (HOE-140)
Sponsored by
University of Edinburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

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

1

2

Arm Description

Prior to 20 mins of ischaemia induced by a blood pressure cuff inflated to 200 mmHg around the upper non-dominant arm, remote ischaemic preconditioning will be induced by inflating a cuff around the dominant arm to 200 mmHg for 5 mins followed by 5 mins of reperfusion. This cycle will be repeated 3 times. Systemic infusion of placebo (saline).

Prior to 20 mins of ischaemia induced by a blood pressure cuff inflated to 200 mmHg around the upper non-dominant arm, remote ischaemic preconditioning will be induced by inflating a cuff around the dominant arm to 200 mmHg for 5 mins followed by 5 mins of reperfusion. This cycle will be repeated 3 times. Systemic infusion of bradykinin receptor antagonist (HOE-140).

Outcomes

Primary Outcome Measures

Change in forearm blood flow in response to vasodilators (ACh(, ischaemia reperfusion and ischaemic preconditioning

Secondary Outcome Measures

Change in platelet-monocyte-binding after ischaemia reperfusion and ischaemic preconditioning

Full Information

First Posted
August 19, 2009
Last Updated
October 22, 2010
Sponsor
University of Edinburgh
Collaborators
University of Aarhus, University of Oxford
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1. Study Identification

Unique Protocol Identification Number
NCT00965393
Brief Title
The Effect of Ischaemic-Reperfusion and Remote Ischaemic Preconditioning in Man - A Bradykinin Dependent Pathway
Official Title
The Effect of Ischaemic-Reperfusion and Remote Ischaemic Preconditioning 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
No

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 at relieving 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, Platelet activation, Endothelial function, Remote ischaemic preconditioning, Bradykinin

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
1
Arm Type
Placebo Comparator
Arm Description
Prior to 20 mins of ischaemia induced by a blood pressure cuff inflated to 200 mmHg around the upper non-dominant arm, remote ischaemic preconditioning will be induced by inflating a cuff around the dominant arm to 200 mmHg for 5 mins followed by 5 mins of reperfusion. This cycle will be repeated 3 times. Systemic infusion of placebo (saline).
Arm Title
2
Arm Type
Active Comparator
Arm Description
Prior to 20 mins of ischaemia induced by a blood pressure cuff inflated to 200 mmHg around the upper non-dominant arm, remote ischaemic preconditioning will be induced by inflating a cuff around the dominant arm to 200 mmHg for 5 mins followed by 5 mins of reperfusion. This cycle will be repeated 3 times. 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)
Placebo
Intervention Description
Systemic infusion of placebo (saline)
Intervention Type
Drug
Intervention Name(s)
bradykinin receptor antagonist (HOE-140)
Intervention Description
Systemic infusion of bradykinin receptor antagonist (HOE-140)
Primary Outcome Measure Information:
Title
Change in forearm blood flow in response to vasodilators (ACh(, ischaemia reperfusion and ischaemic preconditioning
Time Frame
20 fixed timepoints during each study visit (3hrs)
Secondary Outcome Measure Information:
Title
Change in platelet-monocyte-binding after ischaemia reperfusion and ischaemic preconditioning
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
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 and Remote Ischaemic Preconditioning in Man - A Bradykinin Dependent Pathway

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