Coronary Artery DiseaseNCT01405690
The Role Of Noninvasive 320-Row Multidetector Computer Tomography
An observational study of Coronary Artery Disease, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Computer tomography coronary angiogram (CTCA) has emerged as a noninvasive alternative to assessing coronary artery luminal disease. Although the use of noninvasive CTCA for the detection of coronary artery disease is on the rise, the current technology of the 64-row multidetector computer tomography (MDCT) is… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2008to Feb 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: - stable patients undergoing intermediate or high risk elective non-cardiac surgical procedure according to the American Heart Association/American College of Cardiology (AHA/ACC) Guideline for Perioperative Cardiovascular Evaluation for Non-Cardiac Surgery.
Who may be able to join
- Male or female, 18 years and older
- Able to understand and willing to sign the Informed Consent Form
- Undergoing vascular surgery or intermediate risk surgery (these include intraperitoneal, intrathoracic, carotid endarterectomy , head and neck, orthopedics or prostate) AND
- One or more of the following clinical predictors according to the Revised Cardiac Risk Index:
- history of ischemic heart disease (CABG, MI, Stent, positive stress test, Q-waves on ECG)
- Diabetes (requiring insulin)
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- history of congestive heart failure (NYHA I- II)
- history of cerebrovascular disease, any of :
- history of carotid stenosis
- history of ischemic cerebrovascular disease (stroke or TIA)
- Aortic or peripheral vascular disease OR
- Risk of CAD with 3 or more of the following
- Age ≥ 70 years
- Hypertension (medicated)
- Cholesterol (medicated)
- Diabetes (medicated-oral hypoglycemic)
- Family history of coronary artery disease
- -
Who cannot join
- Lack of consent for participation
- Pregnancy
- History of an allergic response to iodinated contrast medium
- History of an allergic response, or other contraindication to beta blockers
- eGFR < 45 mL/min
- Hemodynamically unstable/compromised
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- Urgent surgery
- Atrial fibrillation > 80 bpm
- Uncontrolled tachyarrhythmia
- Atrioventricular block (second and third degree)
- Moderate to severe aortic stenosis
- Not able to hold breath for 5 - 10 seconds
- History of multiple myeloma or organ transplant
- Severe pulmonary disease including COPD, PAH, asthma
- Congestive heart failure presented as NYHA functional class III - IV
- Severe anemia
- Increased intracranial pressure
- Closed angle glaucoma
- Absolute contraindication to Nitroglycerin
- Presence of medical condition or history that investigator feels would be problematic
- Acute myocardial infarction (within 4-6 weeks) -
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Heatlh Network, Mount Sinai, Toronto General Hopsital sites
Toronto, Ontario, M5G 2C4
About this study
Official title: A Pilot Study: The Role Of Noninvasive 320-Row Multidetector Computer Tomography Coronary Angiogram In Predicting Perioperative Cardiac Complications In Patients Referred For Noncardiac Surgery
Computer tomography coronary angiogram (CTCA) has emerged as a noninvasive alternative to assessing coronary artery luminal disease. Although the use of noninvasive CTCA for the detection of coronary artery disease is on the rise, the current technology of the 64-row multidetector computer tomography (MDCT) is subjected to multiple patient artifacts that can affect image quality.To eliminate these patient related artifacts a more advanced 320-row MDCT was recently developed. The investigators therefore propose that the newly developed 320-MDCT can provide an accurate noninvasive assessment of the severity of coronary artery luminal stenosis as an alternative to an invasive coronary angiogram.
Read the detailed description
This pilot study consisting of a prospective non-randomized observational trial where a team of surgeon, anesthesiologist, and evaluator are blinded to CTCA results. We hypothesize that the preoperative use of noninvasive computer tomography, with the 320-row MDCT, to visualize the degree of coronary artery stenosis can lead to improved clinical prediction of perioperative cardiac complications.
The 320-row MDCT is based on the 64-row technology with the significant addition of a larger detector capable of scanning the heart within 1 sec or a cardiac cycle, thereby, eliminating patient-related artifacts and may produce higher image quality.13, 14 The scanning time of 5 seconds with the 320-row MDCT is significantly reduced compared to 8-10 seconds for the 64-row MDCT
- Conditions
- Coronary Artery Disease
- Keywords
- CAD, CTCA, multidetector computer tomography (MDCT)
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the coronary luminal stenosis for location, number of vessels involved and severity of luminal stenosis using noninvasive CTCA.
CTCA will be read by a cardiac radiologist blinded to the patients' medical/cardiac history and the results of the stress test. The cardiac radiologist will classify the severity of coronary artery disease according to number of vessels, location and degree of luminal steno-occlusive disease.
Measured: CTCA 1-2 hours
Secondary outcomes (1)
Perioperative cardiac complications
Non-fatal and fatal cardiac complications will be reviewed day 0- 3 and day 30 post-surgery and one year. Patients who are discharged home will be contacted by telephone by a research assistant for post-operative follow-up. Non-fatal cardiac complications include myocardial infarction, arrythmias, electrocardiogram ischemic changes, cardiac enzymes elevation, symptoms of congestive heart failure and/or angina
Measured: In hospital day 0-3, 30 days post surgery and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2011 (estimated)
- Study startSep 2008
- Primary completionJun 2014
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Mount Sinai Hospital, Canada
- Responsible party
- Sponsor
- Investigators
- Eric You Ten Kong, MD PhD FRCPC, Principal investigator, Mount Sinai Hospital, University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01405690
- Sponsor's protocol ID
- 08-0033-BE
- Status last verified
- Feb 2016
- First submitted
- 27 Jul 2011
- Last updated
- 5 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study: The Role Of Noninvasive 320-Row Multidetector Computer Tomography Coronary Angiogram In Predicting Perioperative Cardiac Complications In Patients Referred For Noncardiac Surgery
- ClinicalTrials.gov ID
- NCT01405690
- Acronym / sponsor ID
- 08-0033-BE
- Conditions
- Coronary Artery Disease
- Keywords
- CAD, CTCA, multidetector computer tomography (MDCT)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Mount Sinai Hospital, Canada
- Study start
- Sep 2008
- Primary completion
- Jun 2014 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 29 Jul 2011 (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.
Computer tomography coronary angiogram (CTCA) has emerged as a noninvasive alternative to assessing coronary artery luminal disease. Although the use of noninvasive CTCA for the detection of coronary artery disease is on the rise, the current technology of the 64-row multidetector computer tomography (MDCT) is subjected to multiple patient artifacts that can affect image quality.To eliminate these patient related artifacts a more advanced 320-row MDCT was recently developed. The investigators therefore propose that the newly developed 320-MDCT can provide an accurate noninvasive assessment of the severity of coronary artery luminal stenosis as an alternative to an invasive coronary angiogram.
Detailed description
This pilot study consisting of a prospective non-randomized observational trial where a team of surgeon, anesthesiologist, and evaluator are blinded to CTCA results. We hypothesize that the preoperative use of noninvasive computer tomography, with the 320-row MDCT, to visualize the degree of coronary artery stenosis can lead to improved clinical prediction of perioperative cardiac complications.
The 320-row MDCT is based on the 64-row technology with the significant addition of a larger detector capable of scanning the heart within 1 sec or a cardiac cycle, thereby, eliminating patient-related artifacts and may produce higher image quality.13, 14 The scanning time of 5 seconds with the 320-row MDCT is significantly reduced compared to 8-10 seconds for the 64-row MDCT
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - stable patients undergoing intermediate or high risk elective non-cardiac surgical procedure according to the American Heart Association/American College of Cardiology (AHA/ACC) Guideline for Perioperative Cardiovascular Evaluation for Non-Cardiac Surgery.
Key inclusion criteria (18 listed)
- Male or female, 18 years and older
- Able to understand and willing to sign the Informed Consent Form
- Undergoing vascular surgery or intermediate risk surgery (these include intraperitoneal, intrathoracic, carotid endarterectomy , head and neck, orthopedics or prostate) AND
- One or more of the following clinical predictors according to the Revised Cardiac Risk Index:
- -
Key exclusion criteria (21 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess the coronary luminal stenosis for location, number of vessels involved and severity of luminal stenosis using noninvasive CTCA.
Time frame: CTCA 1-2 hours
CTCA will be read by a cardiac radiologist blinded to the patients' medical/cardiac history and the results of the stress test. The cardiac radiologist will classify the severity of coronary artery disease according to number of vessels, location and degree of luminal steno-occlusive disease.
1 secondary outcome
Perioperative cardiac complications
Time frame: In hospital day 0-3, 30 days post surgery and one year
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 5 Dec 2016.
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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.
Eric You Ten Kong, MD PhD FRCPC principal investigator
Mount Sinai Hospital, University Health Network
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 Coronary Artery Disease, run by University Health Network, Toronto 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 18 inclusion and 21 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 5 Dec 2016. 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?
To assess the coronary luminal stenosis for location, number of vessels involved and severity of luminal stenosis using noninvasive CTCA. (time frame: CTCA 1-2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2016.