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NCT Number: NCT01405690

The Role Of Noninvasive 320-Row Multidetector Computer Tomography

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Heatlh Network, Mount Sinai, Toronto General Hopsital sites

Toronto, Ontario, M5G 2C4, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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 criteria

  • 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) -

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Mount Sinai Hospital, Canada

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2014
Study completion
2016
First posted
Jul 29, 2011
Registry last updated
Dec 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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