The Effect of Ischaemic-reperfusion on the Endogenous Fibrinolysis in Man
This study has been completed.
Sponsor:
University of Edinburgh
Collaborators:
University of Aarhus
University of Oxford
Information provided by:
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT00789451
First received: November 10, 2008
Last updated: October 22, 2010
Last verified: October 2010
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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 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 [ 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 |
| 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| 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
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: | NCT00789451 History of Changes |
| Other Study ID Numbers: | CMP 1 |
| 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 |
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 May 23, 2013