MedDataX Logo

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

NCT ID: NCT00965120

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ischaemic Heart Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

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).

Group Type PLACEBO_COMPARATOR

Forearm vascular study

Intervention Type PROCEDURE

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

Placebo (saline)

Intervention Type DRUG

Systemic infusion of placebo (saline).

2

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).

Group Type ACTIVE_COMPARATOR

Forearm vascular study

Intervention Type PROCEDURE

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

bradykinin receptor antagonist (HOE-140)

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Forearm vascular study

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

Intervention Type PROCEDURE

bradykinin receptor antagonist (HOE-140)

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

Intervention Type DRUG

Placebo (saline)

Systemic infusion of placebo (saline).

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Aarhus

OTHER

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role collaborator

University of Edinburgh

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University of Edinburgh

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David E Newby, PhD, FRCP

Role: STUDY_DIRECTOR

University of Edinburgh

Rajesh K Kharbanda, PhD, FRCP

Role: STUDY_DIRECTOR

University of Oxford

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Edinburgh, 49 Little France Crescent

Edinburgh, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 21873443 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CMP 3

Identifier Type: -

Identifier Source: org_study_id