The Role Of Noninvasive 320-Row Multidetector Computer Tomography
| Tracking Information | |||||
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| First Received Date ICMJE | July 27, 2011 | ||||
| Last Updated Date | February 21, 2013 | ||||
| Start Date ICMJE | September 2008 | ||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To assess the coronary luminal stenosis for location, number of vessels involved and severity of luminal stenosis using noninvasive CTCA. [ Time Frame: CTCA 1-2 hours ] [ Designated as safety issue: No ] CTCA will be read by a cardiac radiologist blinded to the patients' medical/cardiac history and the results of the stress test. The cardiac radiologist will classify the severity of coronary artery disease according to number of vessels, location and degree of luminal steno-occlusive disease. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01405690 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Perioperative cardiac complications [ Time Frame: In hospital day 0-3, 30 days post surgery and one year ] [ Designated as safety issue: No ] Non-fatal and fatal cardiac complications will be reviewed day 0- 3 and day 30 post-surgery and one year. Patients who are discharged home will be contacted by telephone by a research assistant for post-operative follow-up. Non-fatal cardiac complications include myocardial infarction, arrythmias, electrocardiogram ischemic changes, cardiac enzymes elevation, symptoms of congestive heart failure and/or angina |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Role Of Noninvasive 320-Row Multidetector Computer Tomography | ||||
| Official Title ICMJE | A Pilot Study: The Role Of Noninvasive 320-Row Multidetector Computer Tomography Coronary Angiogram In Predicting Perioperative Cardiac Complications In Patients Referred For Noncardiac Surgery | ||||
| Brief Summary | Computer tomography coronary angiogram (CTCA) has emerged as a noninvasive alternative to assessing coronary artery luminal disease. Although the use of noninvasive CTCA for the detection of coronary artery disease is on the rise, the current technology of the 64-row multidetector computer tomography (MDCT) is subjected to multiple patient artifacts that can affect image quality.To eliminate these patient related artifacts a more advanced 320-row MDCT was recently developed. The investigators therefore propose that the newly developed 320-MDCT can provide an accurate noninvasive assessment of the severity of coronary artery luminal stenosis as an alternative to an invasive coronary angiogram. |
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| Detailed Description | This pilot study consisting of a prospective non-randomized observational trial where a team of surgeon, anesthesiologist, and evaluator are blinded to CTCA results. We hypothesize that the preoperative use of noninvasive computer tomography, with the 320-row MDCT, to visualize the degree of coronary artery stenosis can lead to improved clinical prediction of perioperative cardiac complications. The 320-row MDCT is based on the 64-row technology with the significant addition of a larger detector capable of scanning the heart within 1 sec or a cardiac cycle, thereby, eliminating patient-related artifacts and may produce higher image quality.13, 14 The scanning time of 5 seconds with the 320-row MDCT is significantly reduced compared to 8-10 seconds for the 64-row MDCT |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | - stable patients undergoing intermediate or high risk elective non-cardiac surgical procedure according to the American Heart Association/American College of Cardiology (AHA/ACC) Guideline for Perioperative Cardiovascular Evaluation for Non-Cardiac Surgery. |
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| Condition ICMJE | Coronary Artery Disease | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | January 2014 | ||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01405690 | ||||
| Other Study ID Numbers ICMJE | 08-0033-BE | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | University Health Network, Toronto | ||||
| Study Sponsor ICMJE | University Health Network, Toronto | ||||
| Collaborators ICMJE | Mount Sinai Hospital, Canada | ||||
| Investigators ICMJE |
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| Information Provided By | University Health Network, Toronto | ||||
| Verification Date | February 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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