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Radial Artery Function Following Trans-radial Cardiac Catheterisation

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ClinicalTrials.gov Identifier: NCT02147119
Recruitment Status : Completed
First Posted : May 26, 2014
Last Update Posted : April 7, 2017
Sponsor:
Collaborator:
British Heart Foundation
Information provided by (Responsible Party):
University of Edinburgh

Study Description
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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.

Condition or disease Intervention/treatment
Atherosclerosis Procedure: Coronary angiography

Study Design
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Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Radial Artery Function Following Trans-radial Cardiac Catheterisation
Study Start Date : March 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015
Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients post- cardiac catheterisation Procedure: Coronary angiography


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Stable outpatient population attending for angiography
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02147119


Locations
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United Kingdom
Clinical research facility University Royal Infirmary of Edinburgh
Edinburgh, Midlothian, United Kingdom, eh164sa
Sponsors and Collaborators
University of Edinburgh
British Heart Foundation
Investigators
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Principal Investigator: Andrew J Mitchell, MBChB University of Edinburgh
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT02147119    
Other Study ID Numbers: PG13/32/30205
First Posted: May 26, 2014    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases