Comprehensive Computed Tomography Guidance of Coronary By... | NCT03894423

Studies
Comprehensive Computed Tomography Guidance of Coronary Bypass Graft Surgery

NCT03894423

Sponsor

Stanford University

Status

Active, not recruiting

Last Update Posted

Apr 17, 2026Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

CAD
Atheroscleroses, Coronary
Computed Tomography
Coronary Artery Bypass

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R01HL141712-01A1	U.S. NIH Grant/Contract		View source
MZ-0048352	Other Identifier	OnCore

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2019Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2030Estimated

First Submitted Date

Mar 22, 2019

First Submission Date that Met QC Criteria

Mar 27, 2019

First Posted Date

Mar 28, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2026

Last Update Posted Date

Apr 17, 2026Actual

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH
University of California, San Diego	OTHER
VA Palo Alto Health Care System	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients scheduled to undergo coronary bypass graft surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Koen Nieman, MD, PhD	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Palo Alto Veterans Affaird Healthcare System		Palo Alto	California	94304	United States
Stanford University

IPD Sharing Statement Module

Plan to Share IPD

Description

No current plan to share data

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases