Coronary CT Angiography to Predict Vascular Events In Noncardiac Surgery patIents cOhort evaluatioN (CTA -VISION) Study

Cardiovascular Disease Clinical Trial

— CTA-VISION  

Official title:

Coronary CT Angiography to Predict Vascular Events In Noncardiac Surgery patIents cOhort evaluatioN (CTA -VISION) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01635309
• Other study ID #: CTA-VISION
• Status: Completed
• Phase: N/A
• First received: July 4, 2012
• Last updated: April 27, 2015
• Start date: May 2007
• Est. completion date: November 2014

Study information

• Verified date: April 2015
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Observational

Clinical Trial Summary

Worldwide 200 million adults annually undergo major noncardiac surgery and 5 million of these patients will suffer a major vascular complication. Despite the magnitude of this problem our capacity to predict these events is limited. Although perioperative myocardial infarction (MI) is the most common major perioperative cardiac complication, little is known about its pathophysiology. Coronary computed tomography angiography (CTA) is a potential non-invasive method for the detection of coronary artery disease and cardiac risk stratification in the non-operative setting; however, the value of this test to enhance risk prediction among patients scheduled for noncardiac surgery is unknown. This study is an international prospective cohort study to determine among patients with, or at risk of, atherosclerotic disease who are undergoing noncardiac surgery: 1) if preoperative coronary CTA has additional predictive value for the occurrence of major perioperative cardiac events and 2) the underlying coronary anatomy associated with perioperative MIs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 987
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• age >=45 years

• undergoing non cardiac surgery requiring an overnight stay and general or regional anaesthetic

• at least one of:

1. Coronary Artery Disease (CAD)

2. Peripheral Vascular Disease (PVD)

3. History of Stroke

4. History of Congestive Heart Failure (CHF)

5. Combination of at least 3 of:

• age >= 70 years

• history of treatment for hypertension

• history of treatment for dyslipidemia

• smoking in last 2 years

• diabetic and currently taking insulin or oral diabetic drugs

• history of Transient Ischemic Attack (TIA)

Exclusion Criteria:

• contraindications to CTA

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Other:
• Coronary CT Angiogram
pre-operative coronary CTA

Locations

Country	Name	City	State
Canada	Juravinski Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Sheth T, Chan M, Butler C, Chow B, Tandon V, Nagele P, Mitha A, Mrkobrada M, Szczeklik W, Faridah Y, Biccard B, Stewart LK, Heels-Ansdell D, Devereaux PJ; Coronary Computed Tomographic Angiography and Vascular Events in Noncardiac Surgery Patients Cohort — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative MI		30-days post-operative	No
Secondary	Perioperative Cardiovascular Event		30-days post-operative	No