The Role Of Noninvasive 320-Row Multidetector Computer Tomography

NCT01405690 | Completed

• 1 other identifier: 08-0033-BE
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

CAD; CTCA; multidetector computer tomography (MDCT)

Outcome Measures

Primary Outcomes (1)

• To assess the coronary luminal stenosis for location, number of vessels involved and severity of luminal stenosis using noninvasive CTCA.

  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.

  CTCA 1-2 hours

Secondary Outcomes (1)

• Perioperative cardiac complications

  In hospital day 0-3, 30 days post surgery and one year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Mount Sinai Hospital, Canada: collaborator

Study Sites (1)

University Heatlh Network, Mount Sinai, Toronto General Hopsital sites

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Eric You Ten Kong, MD PhD FRCPC

  Mount Sinai Hospital, University Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2011
• First Posted: July 29, 2011
• Study Start: September 1, 2008
• Primary Completion: June 1, 2014
• Study Completion: February 1, 2016
• Last Updated: December 5, 2016

Record last verified: 2016-02

Locations

CA (1)