Comprehensive Computed Tomography Guidance of Coronary Bypass Graft Surgery

NCT03894423 | Active Not Recruiting

• 3 other identifiers: IRB-499451R01HL141712-01A1MZ-0048352
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Bypass graft obstruction by cardiac CT

  2 Months

• Change in angina pectoris assessed by SAQ

  1 Year

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled to undergo coronary bypass graft surgery

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (3)

Palo Alto Veterans Affaird Healthcare System

Palo Alto, California, 94304, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

University of California San Diego

San Diego, California, 92093, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Koen Nieman, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 22, 2019
• First Posted: March 28, 2019
• Study Start: May 1, 2019
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2030
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)