Comprehensive Computed Tomography Guidance of Coronary Bypass Graft Surgery

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Bypass; Computed Tomography; CAD; Atheroscleroses, Coronary

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University
    • Palo Alto, California, United States, 94304
      • Palo Alto Veterans Affaird Healthcare System
    • San Diego, California, United States, 92093
      • University Of California San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled to undergo coronary bypass graft surgery

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bypass graft obstruction by cardiac CT	The presence of bypass grafts obstruction will be assessed on CT angiography	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.	1 Year

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: University of California, San Diego; National Heart, Lung, and Blood Institute (NHLBI); VA Palo Alto Health Care System
• Investigators: Principal Investigator: Koen Nieman, MD, PhD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: March 22, 2019
• First Submitted That Met QC Criteria: March 27, 2019
• First Posted (Actual): March 28, 2019

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: IRB-49945; 1R01HL141712-01A1 (U.S. NIH Grant/Contract); MZ-0048352 (Other Identifier: OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No current plan to share data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No