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

University of Edinburgh

Status: Completed

Conditions: Ischaemic Heart Diseases

Treatments: Drug: bradykinin receptor antagonist (HOE-140); Drug: Placebo; Procedure: Forearm vascular study

Study type: Interventional

Funder types: Other

Identifiers

NCT00965393

CMP 5

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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12 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

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).

Treatment:

Procedure: Forearm vascular study

Drug: Placebo

2

Active Comparator group

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).

Treatment:

Procedure: Forearm vascular study

Drug: bradykinin receptor antagonist (HOE-140)