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The Effect of Ischaemic-reperfusion on the Endogenous Fibrinolysis in Man

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00789451
First Posted: November 11, 2008
Last Update Posted: October 25, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Aarhus
University of Oxford
Information provided by:
University of Edinburgh
  Purpose
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 minimise 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 us 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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of Ischaemic-reperfusion on the Endogenous Fibrinolysis in Man

Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • Net t-PA release from the endothelium after ischaemia reperfusion [ Time Frame: Throughout the study ]

Secondary Outcome Measures:
  • Change in forearm blood flow after ischaemia reperfusion [ Time Frame: throughout the study ]
  • Change in platelet-monocyte-binding after ischaemia reperfusion [ Time Frame: Throughout the study ]

Estimated Enrollment: 12
Study Start Date: August 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: 1
no ischaemia - only sham. Blood pressure cuff inflation up till 10 mmHg on the upper arm for 20 mins.
Procedure: Forearm vascular study
Forearm blood flow measured by venous occlusion plethysmography during interarterial infusion of substance P (2,4,8 pmol/min). Venous blood sampling via cannula in antecubital fossa.
Active Comparator: 2
Ischaemia 20 minutes. Blood pressure cuff will be inflated around the upper arm for 20 minutes to induce ischaemia.
Procedure: Forearm vascular study
Forearm blood flow measured by venous occlusion plethysmography during interarterial infusion of substance P (2,4,8 pmol/min). Venous blood sampling via cannula in antecubital fossa.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00789451


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christian M Pedersen, clinical research fellow, University of Edinburgh
ClinicalTrials.gov Identifier: NCT00789451     History of Changes
Other Study ID Numbers: CMP 1
First Submitted: November 10, 2008
First Posted: November 11, 2008
Last Update Posted: October 25, 2010
Last Verified: October 2010

Keywords provided by University of Edinburgh:
Ischaemia reperfusion
t-PA
Fibrinolysis
Endothelial function

Additional relevant MeSH terms:
Ischemia
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases