Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
4610
Study information
Scientific title
Contribution of inflammatory mechanisms to myocardial and vascular injury in coronary reperfusion
Acronym
CRF & Endothelial Function
Study hypothesis
This is an observational study investigating the role of inflammation in myocardial microvascular injury following coronary angioplasty and stenting.
Ethics approval
MREC approved (ref: 05/Q1502/72
Study design
Single centre non-randomised observational trial
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics), Generic Health Relevance (all Subtopics); Disease: Cardiovascular, Other
Intervention
Patients undergo measurement of inflammatory markers pre- and post-angioplasty and measurement of microvascular function pre- and post-PCI.
Study entry: registration only
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measures
Degree of change of microvascular function post-PCI
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/2006
Overall trial end date
14/10/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Undergoing single vessel percutaneous coronary intervention (PCI) in left anterior descending (LAD) or circumflex (Cx) artery
2. Without other signficant coronary disease
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
Planned sample size: 50
Participant exclusion criteria
1. Recent acute coronary syndrome (ACS)
2. Other inflammatory disease
3. Asthma
Recruitment start date
01/04/2006
Recruitment end date
14/10/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Cardiothoracic Centre
Liverpool
L14 3PE
United Kingdom
Sponsor information
Organisation
Royal Liverpool University Hospital (UK)
Sponsor details
Research & Development
4th Floor
Linda McCartney Centre
Prescot Street
Liverpool
L7 8XP
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
British Heart Foundation
Alternative name(s)
BHF
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary