NCT00789243

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

October 25, 2010

Status Verified

October 1, 2010

Enrollment Period

1.9 years

First QC Date

November 10, 2008

Last Update Submit

October 22, 2010

Conditions

Ischaemic Heart Diseases

Keywords

Ischaemia reperfusiont-PAFibrinolysisEndothelial functionLocal and remote ischaemic preconditioning

Outcome Measures

Primary Outcomes (1)

  • Net t-PA release from the endothelium after ischaemia reperfusion and ischaemic preconditioning

    Throughout the study

Secondary Outcomes (2)

  • Change in forearm blood flow after ischaemia reperfusion and ischaemic preconditioning

    throughout the study

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

    Throughout the study

Study Arms (3)

1

ACTIVE COMPARATOR

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.

Procedure: Forearm vascular study

2

ACTIVE COMPARATOR

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.

Procedure: Forearm vascular study

3

PLACEBO COMPARATOR

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.

Procedure: Forearm vascular study

Interventions

Forearm vascular studyPROCEDURE

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.

123

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy males between 18-65 years of ages, non-smokers.

You may not qualify if:

  • Any concurrent illness or chronic medical condition. Concurrent use of vasoactive medication. Smoking history.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Edinburgh, 49 Little France Crescent

Edinburgh, EH16 4SB, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 21990263DERIVED

  • 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.

    PMID: 21083644DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • David E Newby, PhD, FRCP

    University of Edinburgh

    STUDY DIRECTOR

  • Rajesh K Kharbanda, PhD, FRCP

    University of Oxford

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 10, 2008

First Posted

November 11, 2008

Study Start

November 1, 2008

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

October 25, 2010

Record last verified: 2010-10

Locations

GB(1)