Coronary Artery BypassNCT01118468
Systematic Assessment of Competitive Flow in Coronary Artery Bypass Grafts by Wave Intensity Analysis
An observational study of Coronary Artery Bypass, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Narrowing of the arteries that supply blood to the heart can lead to heart attacks and death. One way of treating this is to use artery and vein grafts from other parts of the body to bypass the narrowing. However, the blood flow from these grafts "competes" with flow through the natural coronary artery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2010to Dec 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with previous bypass grafts undergoing angiography/ angioplasty who meet stduy criteria
Who may be able to join
- Patients with previous coronary artery bypass grafts undergoing coronary angiography and graft restudy
Who cannot join
- Patient's with cardiac pacemakers, valvular heart disease, and chronic renal failure
- Unable to consent
- Contraindications to adenosine
- Contraindications to cardiac MRI
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College NHS Trust
London
Justin E Davies, MRCP, PhD, 020 7594 33 86, justin.davies@imperial.ac.uk
Sayan Sen, 020 7594 33 86, sayan.sen@imperial.ac.uk
About this study
Narrowing of the arteries that supply blood to the heart can lead to heart attacks and death. One way of treating this is to use artery and vein grafts from other parts of the body to bypass the narrowing. However, the blood flow from these grafts "competes" with flow through the natural coronary artery. This may contribute to grafts narrowing with time. This protocol aims to determine the pressure changes responsible for this effect. This could improve our understanding of why some grafts last longer than others.
- Conditions
- Coronary Artery Bypass
- Keywords
- Competitive Flow, Coronary artery bypass, Wave Intensity Analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery BypassStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Justin E Davies, MRCP PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01118468
- Sponsor's protocol ID
- 1426
- Status last verified
- Feb 2017
- First submitted
- 5 May 2010
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Assessment of Competitive Flow in Coronary Artery Bypass Grafts by Wave Intensity Analysis
- ClinicalTrials.gov ID
- NCT01118468
- Acronym / sponsor ID
- 1426
- Conditions
- Coronary Artery Bypass
- Keywords
- Competitive Flow, Coronary artery bypass, Wave Intensity Analysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 6 May 2010 (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.
Narrowing of the arteries that supply blood to the heart can lead to heart attacks and death. One way of treating this is to use artery and vein grafts from other parts of the body to bypass the narrowing. However, the blood flow from these grafts "competes" with flow through the natural coronary artery. This may contribute to grafts narrowing with time. This protocol aims to determine the pressure changes responsible for this effect. This could improve our understanding of why some grafts last longer than others.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with previous bypass grafts undergoing angiography/ angioplasty who meet stduy criteria
Key inclusion criteria (1 listed)
- Patients with previous coronary artery bypass grafts undergoing coronary angiography and graft restudy
Key exclusion criteria (4 listed)
- Patient's with cardiac pacemakers, valvular heart disease, and chronic renal failure
- Unable to consent
- Contraindications to adenosine
- Contraindications to cardiac MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
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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.
Justin E Davies, MRCP PhD principal investigator
Imperial College London
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 Coronary Artery Bypass, run by Imperial College London 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: status not confirmed, as of the sponsor's last update on 8 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Justin E Davies, MRCP, PhD (020 7594 33 86, justin.davies@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 8 Feb 2017.