Viewing Study NCT01405690



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Last Modification Date: 2024-10-26 @ 10:38 AM
Study NCT ID: NCT01405690
Status: COMPLETED
Last Update Posted: 2016-12-05
First Post: 2011-07-27

Brief Title: The Role Of Noninvasive 320-Row Multidetector Computer Tomography
Sponsor: University Health Network Toronto
Organization: University Health Network Toronto

Study Overview

Official Title: 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
Status: COMPLETED
Status Verified Date: 2016-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 qualityTo 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
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 quality13 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None