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

NCT00789451 | Completed

• 1 other identifier: CMP 1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ischaemic Heart Diseases

Keywords

Ischaemia reperfusion; t-PA; Fibrinolysis; Endothelial function

Outcome Measures

Primary Outcomes (1)

• Net t-PA release from the endothelium after ischaemia reperfusion

  Throughout the study

Secondary Outcomes (2)

• Change in forearm blood flow after ischaemia reperfusion

  throughout the study

• Change in platelet-monocyte-binding after ischaemia reperfusion

  Throughout the study

Study Arms (2)

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

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

Interventions

Forearm vascular study PROCEDURE

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.

1; 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy males between 18-65 years of ages, non-smokers.

You may not qualify if:

• Any concurrent illness or chronic medical condition. Concurrent use of vasoactive medication. Smoking history.

Sponsors & Collaborators

• University of Edinburgh: lead
• University of Aarhus: collaborator
• University of Oxford: collaborator

Study Sites (1)

University of Edinburgh, 49 Little France Crescent

Edinburgh, EH16 4SB, United Kingdom

Location

Related Publications (1)

• Pedersen CM, Cruden NL, Schmidt MR, Lau C, Botker HE, Kharbanda RK, Newby DE. Remote ischemic preconditioning prevents systemic platelet activation associated with ischemia-reperfusion injury in humans. J Thromb Haemost. 2011 Feb;9(2):404-7. doi: 10.1111/j.1538-7836.2010.04142.x. No abstract available.

  PMID: 21083644 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• David E Newby, PhD, FRCP

  University of Edinburgh

  STUDY DIRECTOR

• Rajesh K Kharbanda, PhD, FRCP

  University of Oxford

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 10, 2008
• First Posted: November 11, 2008
• Study Start: August 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: October 25, 2010

Record last verified: 2010-10

Locations

GB (1)