Radial Artery Function Following Trans-radial Cardiac Catheterisation

Atherosclerosis Clinical Trial

Official title:

Radial Artery Function Following Trans-radial Cardiac Catheterisation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02147119
• Other study ID #: PG13/32/30205
• Status: Completed
• Phase: N/A
• First received: April 7, 2014
• Last updated: April 6, 2017
• Start date: March 2014
• Est. completion date: December 2015

Study information

• Verified date: April 2017
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Stable outpatient population aged between 18-85 attending for trans-radial cardiac catheterisation

Exclusion Criteria:

• Recent myocardial infarction (<3 months)

• Severe aortic stenosis

• Chronic renal failure (eGFR<30)

• Inability to give informed consent

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Procedure:
• Coronary angiography

Locations

Country	Name	City	State
United Kingdom	Clinical research facility University Royal Infirmary of Edinburgh	Edinburgh	Midlothian

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	British Heart Foundation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Radial artery injury	Optical coherence tomography examination of the radial artery will be made at baseline and following sheath insertion.	Baseline and up to 1 hour Post angiograpy sheath insertion
Secondary	Endothelial progenitor cell number an function Endothelial progenitor cell number and function		Baseline and at 24 hours post-angiogram