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

University of Edinburgh

Status: Completed

Conditions: Ischaemic Heart Diseases

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00965120

CMP 3

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 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.

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

---

12 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

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).

Treatment:

Procedure: Forearm vascular study

Drug: Placebo (saline)

2

Active Comparator group

Description:

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).

Treatment:

Drug: bradykinin receptor antagonist (HOE-140)

Procedure: Forearm vascular study