Radial Artery Function Following Trans-radial Cardiac Catheterisation
1 other identifier
observational
5
1 country
1
Brief Summary
The investigators will study Radial artery injury and endothelial function following trans-radial cardiac catheterisation. Radial artery injury will be quantified pre- and post- angiography using Optical Coherence Tomography. The participants will also have radial endothelial function assessed using flow-mediated dilatation at baseline, 24 hours, one week, one month and three months post- angiography. Blood will be taken pre and 24 hours post angiography for characterisation of endothelial progenitor cell numbers and function. The hypothesis is that trans-radial catheterisation will cause a reduction in flow-mediated dilatation which peaks at 24 hours and recovers at three months. The investigators hope to correlate the rate of this recovery with peri-procedural progenitor cell numbers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 7, 2014
CompletedFirst Posted
Study publicly available on registry
May 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedApril 7, 2017
April 1, 2017
1.8 years
April 7, 2014
April 6, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Flow-mediated dilatation
Radial artery flow-mediated dilatation will be assessed at the above stated time points
baseline, 24 hours, one week, four weeks and three months post-angiography
Secondary Outcomes (2)
Radial artery injury
Baseline and up to 1 hour Post angiograpy sheath insertion
Endothelial progenitor cell number an function Endothelial progenitor cell number and function
Baseline and at 24 hours post-angiogram
Study Arms (1)
Patients post- cardiac catheterisation
Interventions
Eligibility Criteria
Stable outpatient population attending for angiography
You may qualify if:
- Stable outpatient population aged between 18-85 attending for trans-radial cardiac catheterisation
You may not qualify if:
- Recent myocardial infarction (\<3 months)
- Severe aortic stenosis
- Chronic renal failure (eGFR\<30)
- Inability to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Edinburghlead
- British Heart Foundationcollaborator
Study Sites (1)
Clinical research facility University Royal Infirmary of Edinburgh
Edinburgh, Midlothian, eh164sa, United Kingdom
Related Publications (1)
Mitchell A, Fujisawa T, Mills NL, Brittan M, Newby DE, Cruden NLM. Endothelial Progenitor Cell Biology and Vascular Recovery Following Transradial Cardiac Catheterization. J Am Heart Assoc. 2017 Oct 28;6(11):e006610. doi: 10.1161/JAHA.117.006610.
PMID: 29080864DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew J Mitchell, MBChB
University of Edinburgh
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2014
First Posted
May 26, 2014
Study Start
March 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
April 7, 2017
Record last verified: 2017-04