The Role Of Noninvasive 320-Row Multidetector Computer Tomography

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01405690
Recruitment Status : Completed
First Posted : July 29, 2011
Last Update Posted : December 5, 2016
Mount Sinai Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease
Coronary Artery Disease

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

Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : September 2008
Actual Primary Completion Date : June 2014
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 ]
    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.

Secondary Outcome Measures :
  1. Perioperative cardiac complications [ Time Frame: In hospital day 0-3, 30 days post surgery and one year ]
    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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Inclusion Criteria:

  • 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:

    1. history of ischemic heart disease (CABG, MI, Stent, positive stress test, Q-waves on ECG)
    2. Diabetes (requiring insulin)
    3. history of congestive heart failure (NYHA I- II)
    4. history of cerebrovascular disease, any of :

      1. history of carotid stenosis
      2. history of ischemic cerebrovascular disease (stroke or TIA)
    5. Aortic or peripheral vascular disease OR
    6. Risk of CAD with 3 or more of the following

      1. Age ≥ 70 years
      2. Hypertension (medicated)
      3. Cholesterol (medicated)
      4. Diabetes (medicated-oral hypoglycemic)
      5. Family history of coronary artery disease

        Exclusion Criteria:

        1. Lack of consent for participation
        2. Pregnancy
        3. History of an allergic response to iodinated contrast medium
        4. History of an allergic response, or other contraindication to beta blockers
        5. eGFR < 45 mL/min
        6. Hemodynamically unstable/compromised
        7. Urgent surgery
        8. Atrial fibrillation > 80 bpm
        9. Uncontrolled tachyarrhythmia
        10. Atrioventricular block (second and third degree)
        11. Moderate to severe aortic stenosis
        12. Not able to hold breath for 5 - 10 seconds
        13. History of multiple myeloma or organ transplant
        14. Severe pulmonary disease including COPD, PAH, asthma
        15. Congestive heart failure presented as NYHA functional class III - IV
        16. Severe anemia
        17. Increased intracranial pressure
        18. Closed angle glaucoma
        19. Absolute contraindication to Nitroglycerin
        20. Presence of medical condition or history that investigator feels would be problematic
        21. Acute myocardial infarction (within 4-6 weeks) -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01405690

Canada, Ontario
University Heatlh Network, Mount Sinai, Toronto General Hopsital sites
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Mount Sinai Hospital, Canada
Principal Investigator: Eric You Ten Kong, MD PhD FRCPC Mount Sinai Hospital, University Health Network

Responsible Party: University Health Network, Toronto Identifier: NCT01405690     History of Changes
Other Study ID Numbers: 08-0033-BE
First Posted: July 29, 2011    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: February 2016

Keywords provided by University Health Network, Toronto:
multidetector computer tomography (MDCT)

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases