The Effect of Ischaemic-Reperfusion in Man - A Bradykinin Dependent Pathway
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:
NCT00965120
First received: August 21, 2009
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 to relieve this blockage as quickly as possible to minimize 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 the investigators 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 Drug: bradykinin receptor antagonist (HOE-140) Drug: Placebo (saline) |
| 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 in Man - A Bradykinin Dependent Pathway |
Resource links provided by NLM:
Further study details as provided by University of Edinburgh:
Primary Outcome Measures:
- Change in forearm blood flow in response to vasodilators (ACh) and ischaemia reperfusion [ Time Frame: 20 fixed timepoints during each study visit (3hrs) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in platelet-monocyte-binding after ischaemia reperfusion [ Time Frame: 4 fixed timepoints during each study visit (3hrs) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 12 |
| Study Start Date: | August 2009 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 1
Ischaemia 20 minutes. Blood pressure cuff will be inflated to 200mmHg around the upper arm for 20 minutes to induce ischaemia. Systemic infusion of placebo (saline).
|
Procedure: Forearm vascular study
Forearm blood flow measured by venous occlusion plethysmography during interarterial infusion of vasodilators (Ach). Venous blood sampling via cannula in antecubital fossa.
Drug: Placebo (saline)
Systemic infusion of placebo (saline).
|
|
Active Comparator: 2
Ischaemia 20 minutes. Blood pressure cuff will be inflated to 200mmHg around the upper arm for 20 minutes to induce ischaemia. Systemic infusion of bradykinin receptor antagonist (HOE-140).
|
Procedure: Forearm vascular study
Forearm blood flow measured by venous occlusion plethysmography during interarterial infusion of vasodilators (Ach). Venous blood sampling via cannula in antecubital fossa.
Drug: bradykinin receptor antagonist (HOE-140)
Systemic infusion of bradykinin receptor antagonist (HOE-140).
|
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: NCT00965120
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
| Responsible Party: | Christian M Pedersen, clinical research fellow, University of Edinburgh |
| ClinicalTrials.gov Identifier: | NCT00965120 History of Changes |
| Other Study ID Numbers: | CMP 3 |
| Study First Received: | August 21, 2009 |
| Last Updated: | October 22, 2010 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by University of Edinburgh:
|
Ischaemia reperfusion Bradykinin Platelet activation 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 Bradykinin Kininogens Icatibant Vasodilator Agents Cardiovascular Agents |
Therapeutic Uses Pharmacologic Actions Cysteine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Adrenergic beta-Antagonists |
ClinicalTrials.gov processed this record on June 17, 2013