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

April 27, 2015 updated by: Philip Devereaux, Canadian Institutes of Health Research (CIHR)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

987

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8V5C2
        • Juravinski Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

International non cardiac surgical patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Perioperative MI
Time Frame: 30-days post-operative
30-days post-operative

Secondary Outcome Measures

Outcome Measure
Time Frame
Perioperative Cardiovascular Event
Time Frame: 30-days post-operative
30-days post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Canadian Institutes of Health Research (CIHR)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

July 4, 2012

First Submitted That Met QC Criteria

July 6, 2012

First Posted (Estimate)

July 9, 2012

Study Record Updates

Last Update Posted (Estimate)

April 28, 2015

Last Update Submitted That Met QC Criteria

April 27, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTA-VISION

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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