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The Effect of Ischaemic-Reperfusion and Ischaemic Preconditioning on the Endogenous Fibrinolysis in Man

NCT ID: NCT00789243

Last Updated: 2010-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-10-31

Brief Summary

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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 minimise 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 us to understand the mechanism by which ischaemia-reperfusion injury may occur and to devise new treatments for heart attacks.

Detailed Description

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Conditions

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Ischaemic Heart Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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1

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

Group Type ACTIVE_COMPARATOR

Forearm vascular study

Intervention Type PROCEDURE

Forearm blood flow measured by venous occlusion plethysmography during interarterial infusion of substance P (2,4,8 pmol/min). Venous blood sampling via cannula in antecubital fossa.

2

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.

Group Type ACTIVE_COMPARATOR

Forearm vascular study

Intervention Type PROCEDURE

Forearm blood flow measured by venous occlusion plethysmography during interarterial infusion of substance P (2,4,8 pmol/min). Venous blood sampling via cannula in antecubital fossa.

3

Prior to 20 mins of ischaemia induced by a blood pressure cuff inflated to 200 mmHg around the upper non-dominant arm, sham will be performed by inflating a cuff to 10 mmHg for 5 mins followed by 5 mins of deflation. This cycle will be repeated 3 times.

Group Type PLACEBO_COMPARATOR

Forearm vascular study

Intervention Type PROCEDURE

Forearm blood flow measured by venous occlusion plethysmography during interarterial infusion of substance P (2,4,8 pmol/min). Venous blood sampling via cannula in antecubital fossa.

Interventions

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Forearm vascular study

Forearm blood flow measured by venous occlusion plethysmography during interarterial infusion of substance P (2,4,8 pmol/min). Venous blood sampling via cannula in antecubital fossa.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aarhus

OTHER

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role collaborator

University of Edinburgh

OTHER

Sponsor Role lead

Responsible Party

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University of Edinburgh

Principal Investigators

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David E Newby, PhD, FRCP

Role: STUDY_DIRECTOR

University of Edinburgh

Rajesh K Kharbanda, PhD, FRCP

Role: STUDY_DIRECTOR

University of Oxford

Locations

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University of Edinburgh, 49 Little France Crescent

Edinburgh, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Pedersen CM, Barnes G, Schmidt MR, Botker HE, Kharbanda RK, Newby DE, Cruden NL. Ischaemia-reperfusion injury impairs tissue plasminogen activator release in man. Eur Heart J. 2012 Aug;33(15):1920-7. doi: 10.1093/eurheartj/ehr380. Epub 2011 Oct 11.

Reference Type DERIVED
PMID: 21990263 (View on PubMed)

Pedersen CM, Cruden NL, Schmidt MR, Lau C, Botker HE, Kharbanda RK, Newby DE. Remote ischemic preconditioning prevents systemic platelet activation associated with ischemia-reperfusion injury in humans. J Thromb Haemost. 2011 Feb;9(2):404-7. doi: 10.1111/j.1538-7836.2010.04142.x. No abstract available.

Reference Type DERIVED
PMID: 21083644 (View on PubMed)

Other Identifiers

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CMP 2

Identifier Type: -

Identifier Source: org_study_id