Status:
COMPLETED
The Role Of Noninvasive 320-Row Multidetector Computer Tomography
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Mount Sinai Hospital, Canada
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
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 ...
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 preoperati...
Eligibility Criteria
Inclusion
- Male or female, 18 years and older
- Able to understand and willing to sign the Informed Consent Form
- Undergoing vascular surgery or intermediate risk surgery (these include intraperitoneal, intrathoracic, carotid endarterectomy , head and neck, orthopedics or prostate) AND
- One or more of the following clinical predictors according to the Revised Cardiac Risk Index:
- history of ischemic heart disease (CABG, MI, Stent, positive stress test, Q-waves on ECG)
- Diabetes (requiring insulin)
- history of congestive heart failure (NYHA I- II)
- history of cerebrovascular disease, any of :
- history of carotid stenosis
- history of ischemic cerebrovascular disease (stroke or TIA)
- Aortic or peripheral vascular disease OR
- Risk of CAD with 3 or more of the following
- Age ≥ 70 years
- Hypertension (medicated)
- Cholesterol (medicated)
- Diabetes (medicated-oral hypoglycemic)
- Family history of coronary artery disease
- \-
Exclusion
- Lack of consent for participation
- Pregnancy
- History of an allergic response to iodinated contrast medium
- History of an allergic response, or other contraindication to beta blockers
- eGFR \< 45 mL/min
- Hemodynamically unstable/compromised
- Urgent surgery
- Atrial fibrillation \> 80 bpm
- Uncontrolled tachyarrhythmia
- Atrioventricular block (second and third degree)
- Moderate to severe aortic stenosis
- Not able to hold breath for 5 - 10 seconds
- History of multiple myeloma or organ transplant
- Severe pulmonary disease including COPD, PAH, asthma
- Congestive heart failure presented as NYHA functional class III - IV
- Severe anemia
- Increased intracranial pressure
- Closed angle glaucoma
- Absolute contraindication to Nitroglycerin
- Presence of medical condition or history that investigator feels would be problematic
- Acute myocardial infarction (within 4-6 weeks) -
Key Trial Info
Start Date :
September 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01405690
Start Date
September 1 2008
End Date
February 1 2016
Last Update
December 5 2016
Active Locations (1)
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1
University Heatlh Network, Mount Sinai, Toronto General Hopsital sites
Toronto, Ontario, Canada, M5G 2C4