Clinical trial NCT03894423: Comprehensive Computed Tomography Guidance of Coronary Bypass Graft Surgery
Official title: Comprehensive CT Guided Coronary Bypass Graft Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: CAD
Atheroscleroses, Coronary
Computed Tomography
Coronary Artery Bypass
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: University of California, San Diego
name: VA Palo Alto Health Care System
First posted: 2019-03-28
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled to undergo coronary bypass graft surgery

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in myocardial blood flow from baseline measured by cardiac CT
timeFrame: 2 Months
Secondary outcomes:
measure: Bypass graft obstruction by cardiac CT
timeFrame: 2 Months
measure: Change in angina pectoris assessed by SAQ
timeFrame: 1 Year
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Palo Alto Veterans Affaird Healthcare System
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: San Diego
country: United States
facility: University of California San Diego
state: California
Study officials:
affiliation: Stanford University
name: Koen Nieman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: