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Comprehensive Computed Tomography Guidance of Coronary Bypass Graft Surgery

Comprehensive CT Guided Coronary Bypass Graft Surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03894423
Enrollment
200
Registered
2019-03-28
Start date
2019-05-01
Completion date
2030-12-01
Last updated
2026-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atheroscleroses, Coronary, CAD, Computed Tomography, Coronary Artery Bypass

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.

Interventions

None listed

Sponsors

Stanford University
Lead SponsorOTHER
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
University of California, San Diego
CollaboratorOTHER
VA Palo Alto Health Care System
CollaboratorFED

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in myocardial blood flow from baseline measured by cardiac CT2 MonthsMyocardial 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

MeasureTime frameDescription
Bypass graft obstruction by cardiac CT2 MonthsThe presence of bypass grafts obstruction will be assessed on CT angiography
Change in angina pectoris assessed by SAQ1 YearSeverity of anginal complaints will be assessed using the Seattle Angina Questionnaire before and 1 year after CABG.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORKoen Nieman, MD, PhD

Stanford University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 18, 2026