Coronary DiseaseNCT01169948
320 Multidetector Computed Tomography Prior to Coronary Artery Bypass Surgery
An observational study of Coronary Disease, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
Recent advances in technology have resulted in the development of scanners that can n image the heart arteries within 10 to 20 minutes but without the need for admission to hospital or insertion of catheters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease
- What is being tested?
- Computed tomography scan
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2010to not given
- 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: Outpatients awaiting cardiac surgery.
Who may be able to join
- patients who have undergone conventional coronary angiography and have been referred for coronary artery bypass surgery or valve replacement
Who cannot join
- age less than 18
- pregnancy or breast feeding
- inability to undergo computed tomography scanning
- inability to give informed consent
- severe renal failure (serum creatinine >250umol/l or estimated glomerular filtration rate <15ml/min)
- known allergy to iodinated contrast
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Infirmary of Edinburgh
Edinburgh, Scotland, EH16 4SA
About this study
Official title: 320 Multidetector Computed Tomography in the Preoperative Assessment for Coronary Artery Bypass Graft Surgery
Recent advances in technology have resulted in the development of scanners that can n image the heart arteries within 10 to 20 minutes but without the need for admission to hospital or insertion of catheters. This means that coronary heart disease may be more readily identified (or ruled out) and allow better diagnosis and treatment of patients with symptoms suggesting coronary heart disease. Here, we propose to assess the latest and most powerful scanners to see if it can accurately diagnose the extent of coronary artery disease and facilitate the planning of heart surgery.
- Conditions
- Coronary Disease
- Being tested
- Computed tomography scan
- Keywords
- Coronary disease, Coronary artery bypass, Cardiac surgery, Computed tomography, Coronary angiography
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed tomography scanRadiation
Computed tomography will be performed using a 320 multidetector computed tomography scanner and may include coronary calcium score, coronary angiography and myocardial perfusion scanning.
| Study group | Role | What they receive |
|---|---|---|
| Patients awaiting cardiac surgery | Not described Receives: Radiation: Computed tomography scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary artery stenosis defined qualitatively by trained observers and quantitatively by computer software
Measured: 1 month
Secondary outcomes (1)
Myocardial perfusion defects defined qualitatively by trained observers and quantitatively by computer software
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2010 (estimated)
- Study startJun 2010
Why it stopped: Not funded.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David E Newby, PhD BM DM, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01169948
- Sponsor's protocol ID
- 2009/R/CAR/17
- Status last verified
- Mar 2013
- First submitted
- 14 Jul 2010
- Last updated
- 14 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 320 Multidetector Computed Tomography in the Preoperative Assessment for Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT01169948
- Acronym / sponsor ID
- 2009/R/CAR/17
- Conditions
- Coronary Disease
- Keywords
- Coronary disease, Coronary artery bypass, Cardiac surgery, Computed tomography, Coronary angiography
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Not funded.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- Jun 2010
- First posted
- 26 Jul 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.
Recent advances in technology have resulted in the development of scanners that can n image the heart arteries within 10 to 20 minutes but without the need for admission to hospital or insertion of catheters. This means that coronary heart disease may be more readily identified (or ruled out) and allow better diagnosis and treatment of patients with symptoms suggesting coronary heart disease. Here, we propose to assess the latest and most powerful scanners to see if it can accurately diagnose the extent of coronary artery disease and facilitate the planning of heart surgery.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients awaiting cardiac surgery | – | Radiation: Computed tomography scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients awaiting cardiac surgery.
Key inclusion criteria (1 listed)
- patients who have undergone conventional coronary angiography and have been referred for coronary artery bypass surgery or valve replacement
Key exclusion criteria (6 listed)
- age less than 18
- pregnancy or breast feeding
- inability to undergo computed tomography scanning
- inability to give informed consent
- severe renal failure (serum creatinine >250umol/l or estimated glomerular filtration rate <15ml/min)
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 |
|---|---|---|
| Computed tomography scanComputed tomography will be performed using a 320 multidetector computed tomography scanner and may include coronary calcium score, coronary angiography and myocardial perfusion scanning. | Radiation | Patients awaiting cardiac surgery |
Primary outcome
Coronary artery stenosis defined qualitatively by trained observers and quantitatively by computer software
Time frame: 1 month
1 secondary outcome
Myocardial perfusion defects defined qualitatively by trained observers and quantitatively by computer software
Time frame: 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2013.
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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.
David E Newby, PhD BM DM 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 Coronary Disease, 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 6 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: withdrawn, as of the sponsor's last update on 14 Mar 2013. 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 was withdrawn before enrolling participants, so there are no results.
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?
Coronary artery stenosis defined qualitatively by trained observers and quantitatively by computer software (time frame: 1 month). It is what the study was designed to measure, not a finding.
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 14 Mar 2013.