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NCT Number: NCT03894423

Comprehensive Computed Tomography Guidance of 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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Palo Alto Veterans Affaird Healthcare System, Palo Alto, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Bypass graft obstruction by cardiac CT

    Time frame: 2 Months

    The presence of bypass grafts obstruction will be assessed on CT angiography

  2. Change in angina pectoris assessed by SAQ

    Time frame: 1 Year

    Severity of anginal complaints will be assessed using the Seattle Angina Questionnaire before and 1 year after CABG.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of California, San Diego
  • VA Palo Alto Health Care System

Registry information

Official study title

Comprehensive CT Guided Coronary Bypass Graft Surgery

Important dates

Study start
2019
Primary completion
2026
Study completion
2030
First posted
Mar 28, 2019
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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