The Effect of Ischaemic-Reperfusion and Ischaemic Preconditioning on the Endogenous Fibrinolysis in Man

This study has been completed.
Sponsor:
Collaborators:
University of Aarhus
University of Oxford
Information provided by:
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT00789243
First received: November 10, 2008
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 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 Blind (Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of Ischaemic-Reperfusion and Ischaemic Preconditioning on the Endogenous Fibrinolysis in Man

Resource links provided by NLM:


Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • Net t-PA release from the endothelium after ischaemia reperfusion and ischaemic preconditioning [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in forearm blood flow after ischaemia reperfusion and ischaemic preconditioning [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • Change in platelet-monocyte-binding after ischaemia reperfusion and ischaemic preconditioning [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: November 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Prior to 20 mins of ischaemia induced by a blood pressure cuff inflated to 200 mmHg around the upper non-dominant arm, local ischaemic preconditioning will be induced by inflating a cuff around the non-dominant arm to 200 mmHg for 5 mins followed by 5 mins of reperfusion. This cycle will be repeated 3 times.
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
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.
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.
Placebo Comparator: 3
Prior to 20 mins of ischaemia induced by a blood pressure cuff inflated to 200 mmHg around the upper non-dominant arm, sham will be performed by inflating a cuff to 10 mmHg for 5 mins followed by 5 mins of deflation. This cycle will be repeated 3 times.
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

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: NCT00789243

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 by University of Edinburgh

Additional 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: NCT00789243     History of Changes
Other Study ID Numbers: CMP 2
Study First Received: November 10, 2008
Last Updated: October 22, 2010
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Edinburgh:
Ischaemia reperfusion
t-PA
Fibrinolysis
Endothelial function
Local and remote ischaemic preconditioning

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

ClinicalTrials.gov processed this record on August 21, 2014