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

• Sponsor: Canadian Institutes of Health Research (CIHR) (Other)
• Overall Status: Completed
• CT.gov ID: NCT01635309
• Collaborator: (none)
• Enrollment: 987
• Location: 1
• Duration (Months): 90.1
• Patients Per Site Per Month: 11

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease	Other: Coronary CT Angiogram

Study Design

• Study Type: Observational
• Actual Enrollment: 987 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Coronary CT Angiography to Predict Vascular Events In Noncardiac Surgery patIents cOhort evaluatioN (CTA -VISION) Study
• Study Start Date: May 1, 2007
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Non-cardiac surgical patients >= 45 years old, undergoing non-cardiac surgery requiring regional or general anaesthetic and an overnight stay with cardiac risk factors	Other: Coronary CT Angiogram; pre-operative coronary CTA

Outcome Measures

Primary Outcome Measures

1. Perioperative MI [30-days post-operative]

Secondary Outcome Measures

1. Perioperative Cardiovascular Event [30-days post-operative]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Juravinski Hospital	Hamilton	Ontario	Canada	L8V5C2

Sponsors and Collaborators

• Canadian Institutes of Health Research (CIHR)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Philip Devereaux, Principal Investigator, McMaster University
• ClinicalTrials.gov Identifier: NCT01635309
• Other Study ID Numbers: CTA-VISION
• First Posted: Jul 9, 2012
• Last Update Posted: Apr 28, 2015
• Last Verified: Apr 1, 2015

• Additional relevant MeSH terms: Cardiovascular Diseases

Study Results

No Results Posted as of Apr 28, 2015