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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00965393
Other study ID # CMP 5
Secondary ID
Status Completed
Phase N/A
First received August 19, 2009
Last updated October 22, 2010
Start date August 2009
Est. completion date October 2010

Study information

Verified date October 2010
Source University of Edinburgh
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date October 2010
Est. primary completion date October 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Basic Science


Intervention

Procedure:
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.
Drug:
Placebo
Systemic infusion of placebo (saline)
bradykinin receptor antagonist (HOE-140)
Systemic infusion of bradykinin receptor antagonist (HOE-140)

Locations

Country Name City State
United Kingdom University of Edinburgh, 49 Little France Crescent Edinburgh

Sponsors (3)

Lead Sponsor Collaborator
University of Edinburgh University of Aarhus, University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in forearm blood flow in response to vasodilators (ACh(, ischaemia reperfusion and ischaemic preconditioning 20 fixed timepoints during each study visit (3hrs) No
Secondary Change in platelet-monocyte-binding after ischaemia reperfusion and ischaemic preconditioning 4 fixed timepoints during each study visit (3hrs) No
See also
  Status Clinical Trial Phase
Completed NCT00789243 - The Effect of Ischaemic-Reperfusion and Ischaemic Preconditioning on the Endogenous Fibrinolysis in Man N/A
Recruiting NCT03766529 - Loop Isolation-based Uploading Pre-conditioning
Completed NCT00351260 - BBC ONE - British Bifurcation Coronary Study Phase 3
Completed NCT00965120 - The Effect of Ischaemic-Reperfusion in Man - A Bradykinin Dependent Pathway N/A
Completed NCT00789451 - The Effect of Ischaemic-reperfusion on the Endogenous Fibrinolysis in Man N/A