Comprehensive Computed Tomography Guidance of Coronary Bypass Graft Surgery



Status:Not yet recruiting
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:40 - Any
Updated:3/30/2019
Start Date:April 2019
End Date:July 2023
Contact:Gerri O'Riordian, RN
Email:gor@stanford.edu
Phone:(650) 725-5597

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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.

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.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.
We found this trial at
3
sites
San Diego, California 92093
Principal Investigator: Andrew Kahn, MD
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Palo Alto, California 94304
Principal Investigator: Patricia Nguyen, MD
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Palo Alto, California 94304
Principal Investigator: Koen Nieman, MD, PhD
Phone: 650-736-4363
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Palo Alto, CA
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