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

NCT01635309 | Completed DMC

• 1 other identifier: CTA-VISION
• Study Type: observational
• Target: 987
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• Perioperative MI

  30-days post-operative

Secondary Outcomes (1)

• Perioperative Cardiovascular Event

  30-days post-operative

Study Arms (1)

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

Interventions

Coronary CT Angiogram OTHER

pre-operative coronary CTA

Non-cardiac surgical patients

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

International non cardiac surgical patients

You may qualify if:

• age \>=45 years
• undergoing non cardiac surgery requiring an overnight stay and general or regional anaesthetic
• at least one of:
• Coronary Artery Disease (CAD)
• Peripheral Vascular Disease (PVD)
• History of Stroke
• History of Congestive Heart Failure (CHF)
• 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)

You may not qualify if:

• contraindications to CTA

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR): lead

Study Sites (1)

Juravinski Hospital

Hamilton, Ontario, L8V5C2, Canada

Location

Related Publications (2)

• 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.

  PMID: 25902738 RESULT

• 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.

  PMID: 35041449 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 4, 2012
• First Posted: July 9, 2012
• Study Start: May 1, 2007
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: April 28, 2015

Record last verified: 2015-04

Locations

CA (1)