- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01169948
320 Multidetector Computed Tomography Prior to Coronary Artery Bypass Surgery
March 13, 2013 updated by: University of Edinburgh
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Scotland
-
Edinburgh, Scotland, United Kingdom, EH16 4SA
- Royal Infirmary of Edinburgh
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Outpatients awaiting cardiac surgery.
Description
Inclusion Criteria:
- patients who have undergone conventional coronary angiography and have been referred for coronary artery bypass surgery or valve replacement
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients awaiting cardiac surgery
|
Computed tomography will be performed using a 320 multidetector computed tomography scanner and may include coronary calcium score, coronary angiography and myocardial perfusion scanning.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Coronary artery stenosis defined qualitatively by trained observers and quantitatively by computer software
Time Frame: 1 month
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Myocardial perfusion defects defined qualitatively by trained observers and quantitatively by computer software
Time Frame: 1 month
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David E Newby, PhD BM DM, University of Edinburgh
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Study Registration Dates
First Submitted
July 14, 2010
First Submitted That Met QC Criteria
July 23, 2010
First Posted (Estimate)
July 26, 2010
Study Record Updates
Last Update Posted (Estimate)
March 14, 2013
Last Update Submitted That Met QC Criteria
March 13, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009/R/CAR/17
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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