NCT00965120

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.

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 Aug 2009

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

August 1, 2009

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 21, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2009

Completed
1.1 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

1.2 years

First QC Date

August 21, 2009

Last Update Submit

October 22, 2010

Conditions

Ischaemic Heart Diseases

Keywords

Ischaemia reperfusionBradykininPlatelet activationEndothelial function

Outcome Measures

Primary Outcomes (1)

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

    20 fixed timepoints during each study visit (3hrs)

Secondary Outcomes (1)

  • Change in platelet-monocyte-binding after ischaemia reperfusion

    4 fixed timepoints during each study visit (3hrs)

Study Arms (2)

1

PLACEBO COMPARATOR

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 studyDrug: Placebo (saline)

2

ACTIVE COMPARATOR

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 studyDrug: bradykinin receptor antagonist (HOE-140)

Interventions

Forearm vascular studyPROCEDURE

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

12
bradykinin receptor antagonist (HOE-140)DRUG

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

2
Placebo (saline)DRUG

Systemic infusion of placebo (saline).

1

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 (1)

  • 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.

    PMID: 21873443DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Bradykinin Receptor AntagonistsicatibantSodium Chloride

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

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

August 21, 2009

First Posted

August 25, 2009

Study Start

August 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

October 25, 2010

Record last verified: 2010-10

Locations

GB(1)