Comprehensive Computed Tomography Guidance of Coronary Bypass Graft Surgery

Recruiting

• Conditions: Atheroscleroses, Coronary; CAD; Coronary Artery Bypass; Computed Tomography

• Registration Number: NCT03894423
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2019-03-22
• Study First Submitted QC: 2019-03-27
• Study First Posted: 2019-03-28
• Study Start: 2019-05-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-29
• Primary Completion: 2025-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in myocardial blood flow from baseline measured by cardiac CT	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.

Secondary Outcome Measures

Name	Time	Method
Bypass graft obstruction by cardiac CT	2 Months	The presence of bypass grafts obstruction will be assessed on CT angiography
Change in angina pectoris assessed by SAQ	1 Year	Severity of anginal complaints will be assessed using the Seattle Angina Questionnaire before and 1 year after CABG.

Trial Locations

Locations (3)

University of California San Diego; 🇺🇸 San Diego, California, United States

Palo Alto Veterans Affaird Healthcare System; 🇺🇸 Palo Alto, California, United States

Stanford University; 🇺🇸 Palo Alto, California, United States