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

This study has been completed.
Sponsor:
Collaborators:
University of Aarhus
University of Oxford
Information provided by:
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT00965120
First received: August 21, 2009
Last updated: October 22, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention
Ischaemic Heart Diseases
Procedure: Forearm vascular study
Drug: bradykinin receptor antagonist (HOE-140)
Drug: Placebo (saline)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of Ischaemic-Reperfusion in Man - A Bradykinin Dependent Pathway

Resource links provided by NLM:


Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • Change in forearm blood flow in response to vasodilators (ACh) and ischaemia reperfusion [ Time Frame: 20 fixed timepoints during each study visit (3hrs) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in platelet-monocyte-binding after ischaemia reperfusion [ Time Frame: 4 fixed timepoints during each study visit (3hrs) ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: August 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 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).
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 (saline)
Systemic infusion of placebo (saline).
Active Comparator: 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).
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: bradykinin receptor antagonist (HOE-140)
Systemic infusion of bradykinin receptor antagonist (HOE-140).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00965120

Locations
United Kingdom
University of Edinburgh, 49 Little France Crescent
Edinburgh, United Kingdom, EH16 4SB
Sponsors and Collaborators
University of Edinburgh
University of Aarhus
University of Oxford
Investigators
Study Director: David E Newby, PhD, FRCP University of Edinburgh
Study Director: Rajesh K Kharbanda, PhD, FRCP University of Oxford
  More Information

No publications provided

Responsible Party: Christian M Pedersen, clinical research fellow, University of Edinburgh
ClinicalTrials.gov Identifier: NCT00965120     History of Changes
Other Study ID Numbers: CMP 3
Study First Received: August 21, 2009
Last Updated: October 22, 2010
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Edinburgh:
Ischaemia reperfusion
Bradykinin
Platelet activation
Endothelial function

Additional relevant MeSH terms:
Heart Diseases
Ischemia
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Pathologic Processes
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Bradykinin
Kininogens
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Cysteine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014