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Comprehensive Computed Tomography Guidance of Coronary Bypass Graft Surgery

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ClinicalTrials.gov Identifier: NCT03894423
Recruitment Status : Recruiting
First Posted : March 28, 2019
Last Update Posted : June 16, 2022
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
University of California, San Diego
VA Palo Alto Health Care System
Information provided by (Responsible Party):
Koen Nieman, Stanford University

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.

Condition or disease
CAD Atheroscleroses, Coronary Computed Tomography Coronary Artery Bypass

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comprehensive CT Guided Coronary Bypass Graft Surgery
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled to undergo coronary bypass graft surgery
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03894423


Contacts
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Contact: Nisha Udapa, BS (650) 723-2300 nishaudupa@stanford.edu

Locations
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United States, California
Palo Alto Veterans Affaird Healthcare System Recruiting
Palo Alto, California, United States, 94304
Contact: Grace Liang         
Principal Investigator: Patricia Nguyen, MD         
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Nisha Udupa, BS    650-723-2300    nishaudupa@stanford.edu   
Principal Investigator: Koen Nieman, MD, PhD         
University of California San Diego Recruiting
San Diego, California, United States, 92093
Principal Investigator: Andrew Kahn, MD         
Sponsors and Collaborators
Stanford University
National Heart, Lung, and Blood Institute (NHLBI)
University of California, San Diego
VA Palo Alto Health Care System
Investigators
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Principal Investigator: Koen Nieman, MD, PhD Stanford University
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Responsible Party: Koen Nieman, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03894423    
Other Study ID Numbers: IRB-49945
1R01HL141712-01A1 ( U.S. NIH Grant/Contract )
MZ-0048352 ( Other Identifier: OnCore )
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: June 16, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No current plan to share data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases