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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Philip Devereaux, McMaster University
ClinicalTrials.gov Identifier:
NCT01635309
First received: July 4, 2012
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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 Intervention
Cardiovascular Disease
Other: Coronary CT Angiogram

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Coronary CT Angiography to Predict Vascular Events In Noncardiac Surgery patIents cOhort evaluatioN (CTA -VISION) Study

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Perioperative MI [ Time Frame: 30-days post-operative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Perioperative Cardiovascular Event [ Time Frame: 30-days post-operative ] [ Designated as safety issue: No ]

Estimated Enrollment: 1200
Study Start Date: May 2007
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

International non cardiac surgical patients

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01635309

Locations
Canada, Ontario
Juravinski Hospital
Hamilton, Ontario, Canada, L8V5C2
Sponsors and Collaborators
Canadian Institutes of Health Research (CIHR)
  More Information

No publications provided

Responsible Party: Philip Devereaux, Principal Investigator, McMaster University
ClinicalTrials.gov Identifier: NCT01635309     History of Changes
Other Study ID Numbers: CTA-VISION
Study First Received: July 4, 2012
Last Updated: April 28, 2014
Health Authority: Canada: Canadian Institutes of Health Research

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 26, 2014