Text Size

The Role Of Noninvasive 320-Row Multidetector Computer Tomography

This study is currently recruiting participants.
Verified February 2013 by University Health Network, Toronto
Sponsor:
Collaborator:
Mount Sinai Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01405690
First received: July 27, 2011
Last updated: February 21, 2013
Last verified: February 2013
History of Changes
  Purpose

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
Coronary Artery Disease

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 100
Study Start Date: September 2008
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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) -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01405690

Locations
Canada, Ontario
University Heatlh Network, Mount Sinai, Toronto General Hopsital sites Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Jo Carroll, BHA     416 340-4800 ext 3243     jo.carroll@uhn.on.ca    
Principal Investigator: Eric Kong Eric You Ten, MD PhD            
Sponsors and Collaborators
University Health Network, Toronto
Mount Sinai Hospital, Canada
Investigators
Principal Investigator: Eric You Ten Kong, MD PhD FRCPC Mount Sinai Hospital, University Health Network
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01405690     History of Changes
Other Study ID Numbers: 08-0033-BE
Study First Received: July 27, 2011
Last Updated: February 21, 2013
Health Authority: Canada: Ethics Review Committee

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

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

ClinicalTrials.gov processed this record on May 16, 2013