AtherosclerosisNCT02147119
Radial Artery Function Following Trans-radial Cardiac Catheterisation
An observational study of Atherosclerosis, run by University of Edinburgh at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Coronary angiography
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2014to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stable outpatient population attending for angiography
Who may be able to join
- Stable outpatient population aged between 18-85 attending for trans-radial cardiac catheterisation
Who cannot join
- Recent myocardial infarction (<3 months)
- Severe aortic stenosis
- Chronic renal failure (eGFR<30)
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Clinical research facility University Royal Infirmary of Edinburgh
Edinburgh, Midlothian, eh164sa
About this study
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.
- Conditions
- Atherosclerosis
- Being tested
- Coronary angiography
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary angiographyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients post- cardiac catheterisation | Not described Receives: Procedure: Coronary angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Flow-mediated dilatation
Radial artery flow-mediated dilatation will be assessed at the above stated time points
Measured: baseline, 24 hours, one week, four weeks and three months post-angiography
Secondary outcomes (2)
Radial artery injury
Optical coherence tomography examination of the radial artery will be made at baseline and following sheath insertion.
Measured: Baseline and up to 1 hour Post angiograpy sheath insertion
Endothelial progenitor cell number an function Endothelial progenitor cell number and function
Measured: Baseline and at 24 hours post-angiogram
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation
- Responsible party
- Sponsor
- Investigators
- Andrew J Mitchell, MBChB, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147119
- Sponsor's protocol ID
- PG13/32/30205
- Status last verified
- Apr 2017
- First submitted
- 7 Apr 2014
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29080864
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radial Artery Function Following Trans-radial Cardiac Catheterisation
- ClinicalTrials.gov ID
- NCT02147119
- Acronym / sponsor ID
- PG13/32/30205
- Conditions
- Atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- British Heart Foundation
- Study start
- Mar 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients post- cardiac catheterisation | – | Procedure: Coronary angiography |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stable outpatient population attending for angiography
Key inclusion criteria (1 listed)
- Stable outpatient population aged between 18-85 attending for trans-radial cardiac catheterisation
Key exclusion criteria (4 listed)
- Recent myocardial infarction (<3 months)
- Severe aortic stenosis
- Chronic renal failure (eGFR<30)
- Inability to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary angiography | Procedure or surgery | Patients post- cardiac catheterisation |
Primary outcome
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
2 secondary outcomes
Radial artery injury
Time frame: Baseline and up to 1 hour Post angiograpy sheath insertion
Endothelial progenitor cell number an function Endothelial progenitor cell number and function
Time frame: Baseline and at 24 hours post-angiogram
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Derived from this study: PubMed 29080864Mitchell 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.
Related trials for Atherosclerosis
Recruiting
Effects of Pitavastatin or Combination of Pitavastatin and Ezetimibe on Glucose Metabolism Compared to AtoRvastatin in atheroscLerotic Cardiovascular Disease Patients With Metabolic Syndrome: The EZ-PEARL Randomized Trial
Dyslipidemias, Atherosclerotic Cardiovascular Disease
Recruiting
Pharmacogenomic Informed Statin Prescribing
Hypercholesterolemia
Recruiting
Aggressive Lipid Lowering Therapy in ICI-Treated Melanoma
Melanoma
Not yet recruitingPhase 4
Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease: A Randomized Controlled Trial
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, Stroke (CVA) or TIA
Not yet recruitingObservational study
Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis
Femoropopliteal In-Stent Restenosis (ISR)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew J Mitchell, MBChB principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Flow-mediated dilatation (time frame: baseline, 24 hours, one week, four weeks and three months post-angiography). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02147119, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2017.