The Role Of Noninvasive 320-Row Multidetector Computer Tomography

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2016-02-29

Brief Summary

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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.

Detailed Description

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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

Conditions

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Coronary Artery Disease

Keywords

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CAD CTCA multidetector computer tomography (MDCT)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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) -

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric You Ten Kong, MD PhD FRCPC

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai Hospital, University Health Network

Locations

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University Heatlh Network, Mount Sinai, Toronto General Hopsital sites

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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08-0033-BE

Identifier Type: -

Identifier Source: org_study_id