Condition category
Circulatory System
Date applied
07/07/2010
Date assigned
07/07/2010
Last edited
12/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Billal Patel

ORCID ID

Contact details

The Cardiothoracic Centre
Thomas Drive
Liverpool
L14 3PE
United Kingdom

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

http://www.rlbuht.nhs.uk/

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

Publication citations

Additional files

Editorial Notes

12/08/2016: No publications found in PubMed, verifying study status with principal investigator.