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

Sponsors and Collaborators:	University of Edinburgh University of Aarhus University of Oxford
Information provided by:	University of Edinburgh
ClinicalTrials.gov Identifier:	NCT00789243

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

MedlinePlus related topics: Heart Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment
Official Title:	The Effect of Ischaemic-Reperfusion and Ischaemic Preconditioning 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 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
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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.
2: Active Comparator 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.
3: Placebo Comparator 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00789243

Contacts

Contact: Christian M Pedersen, MD

+441312426437

Christian.M.Pedersen@ed.ac.uk

Locations

United Kingdom
University of Edinburgh, 49 Little France Crescent	Recruiting
Edinburgh, United Kingdom, EH16 4SB
Principal Investigator: Christian M Pedersen, MD
Sub-Investigator: Nick Cruden, MD, PhD
Sub-Investigator: David E Newby, PhD, FRCP
Sub-Investigator: Rajesh K Kharbanda, PhD, FRCP
Sub-Investigator: Gareth Barnes, MD

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:	University of Edinburgh ( Christian M Pedersen, clinical research fellow )
Study ID Numbers:	CMP 2
Study First Received:	November 10, 2008
Last Updated:	November 10, 2008
ClinicalTrials.gov Identifier:	NCT00789243 History of Changes
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

Study placed in the following topic categories:

Heart Diseases
Myocardial Ischemia
Vascular Diseases

Tissue Plasminogen Activator
Ischemia
Substance P

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Cardiovascular Diseases
Ischemia

ClinicalTrials.gov processed this record on May 07, 2009