CADNCT03894423
Comprehensive Computed Tomography Guidance of Coronary Bypass Graft Surgery
An observational study of CAD and Atheroscleroses, Coronary, run by Stanford University at 3 sites in United States.
Trial summary
Apply CT angiography, CT perfusion imaging and advanced image processing techniques to improve revascularization decision-making and surgical strategies in patients undergoing coronary artery bypass graft surgery. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- CAD, Atheroscleroses, Coronary, Computed Tomography
- How many people
- 200 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 May 2019to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled to undergo coronary bypass graft surgery
Who may be able to join
- Planned elective CABG for coronary artery disease.
- CABG is the primary indication for surgery (but may include treatment of mild-moderate valvular disease).
- Age: ≥40 years.
Who cannot join
- Technical feasibility of the cardiac CT exams: redo-CABG, significant arrhythmia/mal-conduction, congenital conditions, severe valvular disease or cardiomyopathy (to the extent that the CT acquisition is technically challenged), inadequate understanding of the English language (to provide consent or follow instructions during the exams).
- Overall safety: unstable clinical condition (clinical heart failure, unstable angina, myocardial infarction <1 month prior).
- Radiation risk: pregnancy (cannot be ruled out), body weight >100kg.
- CT contrast medium-related: known allergy, renal failure
- Vasodilator related: known allergy, bronchial asthma requiring daily use of bronchodilators, Mobitz II or 3rd degree AV block, sick sinus node disease, clinically significant carotid artery narrowing, severe aortic stenosis or LVOT narrowing, systolic blood pressure below 90mmHg, (continued) use of dipyridamole or aminophylline.
- Inability to provide informed consent.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Palo Alto Veterans Affaird Healthcare System
Palo Alto, California, 94304
Stanford University
Palo Alto, California, 94304
University of California San Diego
San Diego, California, 92093
About this study
Official title: Comprehensive CT Guided Coronary Bypass Graft Surgery
Apply CT angiography, CT perfusion imaging and advanced image processing techniques to improve revascularization decision-making and surgical strategies in patients undergoing coronary artery bypass graft surgery.
Read the detailed description
The objective of this study is to integrate noninvasively acquired anatomical and functional information to develop clinically applicable tools for meaningful per-vessel revascularization decisions. The decisions will be based on quantitative lesion-specific ischemia and viability and flow simulations. These will be based on CT anatomy enhanced with a function for prediction of hemodynamic improvement after CABG.
Aim 1: Predict restoration of myocardial perfusion from coronary artery bypass graft surgery. The investigators will perform cardiac CT before and after CABG and measure absolute changes in myocardial perfusion as the functional outcome of CABG. The investigators will investigate clinical, surgical and imaging variables in association with post-CABG perfusion improvement on a per-vessel and per-patient level.
Aim 2: Non-invasively quantify vessel-specific ischemia for meaningful CABG decisions.
The investigators will develop and validate tools for assessment of vessel-specific ischemia and viability. The investigators will assess the potential impact of CT guided CABG by comparing the per-vessel need for grafting with standard care.
Aim 3: Predict CABG benefit through multi-parameter flow simulations Hypothesis: Integration of myocardial perfusion and viability can improve flow simulation models to predict CABG outcome. The investigators will develop new computational fluid dynamics models enriched with functional parameters and explore the potential of virtual grafting to improve hemodynamic outcomes.
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in myocardial blood flow from baseline measured by cardiac CT
Myocardial blood flow will be measured by dynamic stress CT perfusion imaging before and 2 months after CABG. The primary endpoint is the difference MBF values between both examinations, per coronary distribution.
Measured: 2 Months
Secondary outcomes (2)
Bypass graft obstruction by cardiac CT
The presence of bypass grafts obstruction will be assessed on CT angiography
Measured: 2 Months
Change in angina pectoris assessed by SAQ
Severity of anginal complaints will be assessed using the Seattle Angina Questionnaire before and 1 year after CABG.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start1 May 2019
- Primary completionDec 2026 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CADStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of California, San Diego, VA Palo Alto Health Care System
- Responsible party
- Principal investigator, Koen Nieman, Stanford University
- Investigators
- Koen Nieman, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894423
- Sponsor's protocol ID
- IRB-49945
- Other IDs
- 1R01HL141712-01A1, MZ-0048352
- Status last verified
- Apr 2026
- First submitted
- 22 Mar 2019
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No current plan to share data
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive CT Guided Coronary Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT03894423
- Acronym / sponsor ID
- IRB-49945
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of California, San Diego, VA Palo Alto Health Care System
- Study start
- 1 May 2019 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 28 Mar 2019 (actual)
- 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.
Apply CT angiography, CT perfusion imaging and advanced image processing techniques to improve revascularization decision-making and surgical strategies in patients undergoing coronary artery bypass graft surgery.
Detailed description
The objective of this study is to integrate noninvasively acquired anatomical and functional information to develop clinically applicable tools for meaningful per-vessel revascularization decisions. The decisions will be based on quantitative lesion-specific ischemia and viability and flow simulations. These will be based on CT anatomy enhanced with a function for prediction of hemodynamic improvement after CABG.
Aim 1: Predict restoration of myocardial perfusion from coronary artery bypass graft surgery. The investigators will perform cardiac CT before and after CABG and measure absolute changes in myocardial perfusion as the functional outcome of CABG. The investigators will investigate clinical, surgical and imaging variables in association with post-CABG perfusion improvement on a per-vessel and per-patient level.
Aim 2: Non-invasively quantify vessel-specific ischemia for meaningful CABG decisions.
The investigators will develop and validate tools for assessment of vessel-specific ischemia and viability. The investigators will assess the potential impact of CT guided CABG by comparing the per-vessel need for grafting with standard care.
Aim 3: Predict CABG benefit through multi-parameter flow simulations Hypothesis: Integration of myocardial perfusion and viability can improve flow simulation models to predict CABG outcome. The investigators will develop new computational fluid dynamics models enriched with functional parameters and explore the potential of virtual grafting to improve hemodynamic outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled to undergo coronary bypass graft surgery
Key inclusion criteria (3 listed)
- Planned elective CABG for coronary artery disease.
- CABG is the primary indication for surgery (but may include treatment of mild-moderate valvular disease).
- Age: ≥40 years.
Key exclusion criteria (6 listed)
- Technical feasibility of the cardiac CT exams: redo-CABG, significant arrhythmia/mal-conduction, congenital conditions, severe valvular disease or cardiomyopathy (to the extent that the CT acquisition is technically challenged), inadequate understanding of the English language (to provide consent or follow instructions during the exams).
- Overall safety: unstable clinical condition (clinical heart failure, unstable angina, myocardial infarction <1 month prior).
- Radiation risk: pregnancy (cannot be ruled out), body weight >100kg.
- CT contrast medium-related: known allergy, renal failure
- Vasodilator related: known allergy, bronchial asthma requiring daily use of bronchodilators, Mobitz II or 3rd degree AV block, sick sinus node disease, clinically significant carotid artery narrowing, severe aortic stenosis or LVOT narrowing, systolic blood pressure below 90mmHg, (continued) use of dipyridamole or aminophylline.
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
Change in myocardial blood flow from baseline measured by cardiac CT
Time frame: 2 Months
Myocardial blood flow will be measured by dynamic stress CT perfusion imaging before and 2 months after CABG. The primary endpoint is the difference MBF values between both examinations, per coronary distribution.
2 secondary outcomes
Bypass graft obstruction by cardiac CT
Time frame: 2 Months
Change in angina pectoris assessed by SAQ
Time frame: 1 Year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No. No current plan to share data
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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.
Koen Nieman, MD, PhD principal investigator
Stanford University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CAD and Atheroscleroses, Coronary, run by Stanford University at 3 sites in United States.
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 3 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in myocardial blood flow from baseline measured by cardiac CT (time frame: 2 Months). 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 17 Apr 2026.