Comprehensive Computed Tomography Guidance of Coronary Bypass Graft Surgery

Coronary Artery Bypass Clinical Trial

Official title:

Comprehensive CT Guided Coronary Bypass Graft Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03894423
• Other study ID #: IRB-49945
• Secondary ID: 1R01HL141712-01A
• Status: Recruiting
• Start date: May 1, 2019
• Est. completion date: January 2026

Study information

• Verified date: November 2023
• Source: Stanford University
• Contact: Sarah Magee
• Phone: (650) 723-2300
• Email: smagee2[@]stanford.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atheroscleroses, Coronary
• Atherosclerosis
• CAD
• Computed Tomography
• Coronary Artery Bypass
• Coronary Artery Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
United States	Palo Alto Veterans Affaird Healthcare System	Palo Alto	California
United States	Stanford University	Palo Alto	California
United States	University of California San Diego	San Diego	California

Sponsors (4)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Bypass graft obstruction by cardiac CT	The presence of bypass grafts obstruction will be assessed on CT angiography	2 Months
Secondary	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