Cardiovascular DiseaseCTA-VISIONNCT01635309
Coronary CT Angiography to Predict Vascular Events In Noncardiac Surgery patIents cOhort evaluatioN (CTA -VISION) Study
An observational study of Cardiovascular Disease, run by Canadian Institutes of Health Research (CIHR) at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Coronary CT Angiogram
- How many people
- 987 participants
- Where
- 1 siteCanada
- Study dates
- May 2007to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: International non cardiac surgical patients
Who may be able to join
- 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
Show all 14Show fewer
- 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)
Who cannot join
- contraindications to CTA
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Coronary CT Angiogram
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary CT AngiogramOther
pre-operative coronary CTA
| Study group | Role | What they receive |
|---|---|---|
| Non-cardiac surgical patients | >= 45 years old, undergoing non-cardiac surgery requiring regional or general anaesthetic and an overnight stay with cardiac risk factors Receives: Other: Coronary CT Angiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative MI
Measured: 30-days post-operative
Secondary outcomes (1)
Perioperative Cardiovascular Event
Measured: 30-days post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2012 (estimated)
- Study startMay 2007
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 987 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Institutes of Health Research (CIHR)
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Philip Devereaux, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635309
- Sponsor's protocol ID
- CTA-VISION
- Acronym
- CTA-VISION
- Status last verified
- Apr 2015
- First submitted
- 4 Jul 2012
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25902738Walpot 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.
PubMed 35041449
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary CT Angiography to Predict Vascular Events In Noncardiac Surgery patIents cOhort evaluatioN (CTA -VISION) Study
- ClinicalTrials.gov ID
- NCT01635309
- Acronym / sponsor ID
- CTA-VISION / CTA-VISION
- Conditions
- Cardiovascular Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 987 participants (actual)
- Lead sponsor
- Canadian Institutes of Health Research (CIHR)Other government
- Study start
- May 2007
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 9 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-cardiac surgical patients | – | Other: Coronary CT Angiogram>= 45 years old, undergoing non-cardiac surgery requiring regional or general anaesthetic and an overnight stay with cardiac risk factors |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- International non cardiac surgical patients
Key inclusion criteria (14 listed)
- age >=45 years
- undergoing non cardiac surgery requiring an overnight stay and general or regional anaesthetic
- at least one of:
- age >= 70 years
- history of treatment for hypertension
Key exclusion criteria (1 listed)
- contraindications to CTA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary CT Angiogrampre-operative coronary CTA | Other | Non-cardiac surgical patients |
Primary outcome
Perioperative MI
Time frame: 30-days post-operative
1 secondary outcome
Perioperative Cardiovascular Event
Time frame: 30-days post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
- Results publication: PubMed 25902738Sheth 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.
- Derived from this study: PubMed 35041449Walpot 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease, run by Canadian Institutes of Health Research (CIHR) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative MI (time frame: 30-days post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01635309, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2015.