The Effect of Ischaemic-Reperfusion in Man - A Bradykinin Dependent Pathway

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00965120
• Date of registration: 21/08/2009
• Primary sponsor: University of Edinburgh
• Public title: The Effect of Ischaemic-Reperfusion in Man - A Bradykinin Dependent Pathway
• Scientific title: The Effect of Ischaemic-Reperfusion in Man - A Bradykinin Dependent Pathway
• Date of first enrolment: August 2009
• Target sample size: 12
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00965120
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Countries of recruitment

United Kingdom

Contacts

• Name: David E Newby, PhD, FRCP
• Affiliation: University of Edinburgh

• Name: Rajesh K Kharbanda, PhD, FRCP
• Affiliation: University of Oxford

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Ischaemic Heart Diseases

Intervention(s)

Drug: bradykinin receptor antagonist (HOE-140)

Drug: Placebo (saline)

Procedure: Forearm vascular study

Primary Outcome(s)

Change in forearm blood flow in response to vasodilators (ACh) and ischaemia reperfusion [Time Frame: 20 fixed timepoints during each study visit (3hrs)]

Secondary Outcome(s)

Change in platelet-monocyte-binding after ischaemia reperfusion [Time Frame: 4 fixed timepoints during each study visit (3hrs)]

Secondary ID(s)

CMP 3

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Aarhus

University of Oxford