The Role Of Noninvasive 320-Row Multidetector Computer Tomography

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01405690
• Other study ID #: 08-0033-BE
• Status: Completed
• Phase: N/A
• First received: July 27, 2011
• Last updated: December 2, 2016
• Start date: September 2008
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2016
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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) -

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Canada	University Heatlh Network, Mount Sinai, Toronto General Hopsital sites	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Mount Sinai Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Perioperative cardiac complications	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	In hospital day 0-3, 30 days post surgery and one year	No