Clinical trial NCT01635309: Coronary CT Angiography to Predict Vascular Events In Noncardiac Surgery patIents cOhort evaluatioN (CTA -VISION) Study
Official title: Coronary CT Angiography to Predict Vascular Events In Noncardiac Surgery patIents cOhort evaluatioN (CTA -VISION) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2012-07-09
Enrollment: 987
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: International non cardiac surgical patients

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.


Eligibility 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

Primary outcomes:
measure: Perioperative MI
timeFrame: 30-days post-operative
Secondary outcomes:
measure: Perioperative Cardiovascular Event
timeFrame: 30-days post-operative
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Juravinski Hospital
state: Ontario
Study officials:
References:
citation: 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 Evaluation Study Investigators. Prognostic capabilities of coronary computed tomographic angiography before non-cardiac surgery: prospective cohort study. BMJ. 2015 Apr 22;350:h1907. doi: 10.1136/bmj.h1907.
citation: Walpot J, Massalha S, Jayasinghe P, Sadaf M, Clarkin O, Godkin L, Sharma A, Ratnayake I, Godkin K, Jia K, Hossain A, Crean AM, Chan M, Butler C, Tandon V, Nagele P, Woodard PK, Mrkobrada M, Szczeklik W, Aziz YFA, Biccard B, Devereaux PJ, Sheth T, Chow BJW. Normalized Subendocardial Myocardial Attenuation on Coronary Computed Tomography Angiography Predicts Postoperative Adverse Cardiovascular Events: Coronary CTA VISION Substudy. Circ Cardiovasc Imaging. 2022 Jan;15(1):e012654. doi: 10.1161/CIRCIMAGING.121.012654. Epub 2022 Jan 18.