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Completed

NCT Number: NCT02147119

Radial Artery Function Following Trans-radial Cardiac Catheterisation

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.

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical research facility University Royal Infirmary of Edinburgh

Edinburgh, Midlothian, eh164sa, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coronary Angiography

Procedure

Primary outcomes

  1. Change in Flow-mediated dilatation

    Time frame: baseline, 24 hours, one week, four weeks and three months post-angiography

    Radial artery flow-mediated dilatation will be assessed at the above stated time points

Secondary outcomes

  1. Radial artery injury

    Time frame: Baseline and up to 1 hour Post angiograpy sheath insertion

    Optical coherence tomography examination of the radial artery will be made at baseline and following sheath insertion.

  2. Endothelial progenitor cell number an function Endothelial progenitor cell number and function

    Time frame: Baseline and at 24 hours post-angiogram

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • British Heart Foundation

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 26, 2014
Registry last updated
Apr 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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