The Effect of Ischaemic-Reperfusion 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:	NCT00789451

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

Drug Information available for: Alteplase Tissue-type plasminogen activator

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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in forearm blood flow after ischaemia reperfusion [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Change in platelet-monocyte-binding after ischaemia reperfusion [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	August 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: Sham Comparator 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.
2: Active Comparator 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

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: NCT00789451

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, MD, PhD
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

Responsible Party:	University of Edinburgh ( Christian M Pedersen, clinical research fellow )
Study ID Numbers:	CMP 1
Study First Received:	November 10, 2008
Last Updated:	November 10, 2008
ClinicalTrials.gov Identifier:	NCT00789451
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by University of Edinburgh:

Ischaemia reperfusion
t-PA
Fibrinolysis
Endothelial function

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
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009