PET MYOCARDIAL Blood Flow Comparison to Coronary CTA and CT-FFR
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PET-cCTA-cFFR
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- 18-90 years of age, of either sex
- Patients presenting with stable angina and a moderate pretest likelihood for CAD and scheduled to undergo ICA for the clinical indication of angina. Subjects will undergo this study within 45 days prior to the cardiac catheterization. This study can also be performed 45 days after the cardiac catheterization if the patient had no interventions.
Exclusion Criteria:
- Prior history of stenting, coronary artery bypass graft surgery, or myocardial infarction, unstable angina, atrial fibrillation, second or third degree atrioventricular block, class IV heart failure
- Iodine allergy
- Renal dysfunction (creatinine above normal laboratory limits)
- Symptomatic asthma
- Women who are pregnant or breast-feeding
Sites / Locations
- Washington University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
PET-cCTA-cFFR
Arm Description
patients presenting with stable angina and a moderate pretest likelihood for CAD who are already scheduled to undergo ICA for the clinical indication of angina will be recruited to undergo PET-cCTA-cFFR
Outcomes
Primary Outcome Measures
Number of flow-limiting coronary artery stenosis on CT
CT presence of flow limiting stenosis (≤ 0.8) as determined by CT-FFR in comparison to invasive coronary artery (ICA) FFR.
Reduction in myocardial myocardial blood flow (MBF) on PET
Decreased MBF (mL/g/min) in regions of coronary stenosis ≥ 50% diameter by CCTA.
Secondary Outcome Measures
Full Information
NCT ID
NCT05349084
First Posted
April 11, 2022
Last Updated
September 6, 2023
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05349084
Brief Title
PET MYOCARDIAL Blood Flow Comparison to Coronary CTA and CT-FFR
Official Title
PET MYOCARDIAL Blood Flow Comparison to Coronary CTA and CT-FFR
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 6, 2019 (Actual)
Primary Completion Date
July 18, 2023 (Actual)
Study Completion Date
July 18, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The broad, long-term objective of this pilot study is to develop an optimal, clinically usable, non-invasive evaluation of Coronary Artery Disease (CAD) in the setting of stable angina which provides both anatomic and functional information.
Patients already scheduled to undergo Invasive coronary catheterization (ICA) for the clinical indication of angina will be recruited to under go stress-rest Positron Emission Tomography-Coronary CT Angiography-Fractional Flow Reserve (PET-cCTA-cFFR)
Detailed Description
This is a single cohort, technology assessment study. Thirty-five patients presenting with stable angina and a moderate pretest likelihood for CAD who are already scheduled to undergo invasive coronary angiography (ICA) for the clinical indication of angina will be recruited to undergo a cCTA examination with FFR followed immediately by regadenoson stress-rest PET on the same PET/CT scanner.
Sensitivity, specificity, NPV, PPV of CTA-cFFR will be obtained using the reference standard of standard of care ICA with FFR for each epicardial coronary artery.
Segmental stress PET MBF will be compared to presence or absence of a coronary artery stenosis ≥ 50% diameter on CCTA and ICA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PET-cCTA-cFFR
Arm Type
Other
Arm Description
patients presenting with stable angina and a moderate pretest likelihood for CAD who are already scheduled to undergo ICA for the clinical indication of angina will be recruited to undergo PET-cCTA-cFFR
Intervention Type
Diagnostic Test
Intervention Name(s)
PET-cCTA-cFFR
Intervention Description
patients presenting with stable angina and a moderate pretest likelihood for CAD who are already scheduled to undergo ICA for the clinical indication of angina will be recruited to undergo PET-cCTA-cFFR
Primary Outcome Measure Information:
Title
Number of flow-limiting coronary artery stenosis on CT
Description
CT presence of flow limiting stenosis (≤ 0.8) as determined by CT-FFR in comparison to invasive coronary artery (ICA) FFR.
Time Frame
Day 1 - Day of Scan
Title
Reduction in myocardial myocardial blood flow (MBF) on PET
Description
Decreased MBF (mL/g/min) in regions of coronary stenosis ≥ 50% diameter by CCTA.
Time Frame
Day 1 - Day of Scan
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-90 years of age, of either sex
Patients presenting with stable angina and a moderate pretest likelihood for CAD and scheduled to undergo ICA for the clinical indication of angina. Subjects will undergo this study within 45 days prior to the cardiac catheterization. This study can also be performed 45 days after the cardiac catheterization if the patient had no interventions.
Exclusion Criteria:
Prior history of stenting, coronary artery bypass graft surgery, or myocardial infarction, unstable angina, atrial fibrillation, second or third degree atrioventricular block, class IV heart failure
Iodine allergy
Renal dysfunction (creatinine above normal laboratory limits)
Symptomatic asthma
Women who are pregnant or breast-feeding
Facility Information:
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The investigators may share your images with other researchers. They may be doing research in areas similar to this research or in other unrelated areas. These researchers may be at Washington University, at other research centers and institutions, or industry sponsors of research. The investigators may also share your research data with large data repositories (a repository is a database of information) for broad sharing with the research community. If the individual research data is placed in one of these repositories only qualified researchers, who have received prior approval from individuals that monitor the use of the data, will be able to look at the information.
IPD Sharing Time Frame
Beginning 3 months and ending 10 years following article publication.
IPD Sharing Access Criteria
Proposals should be directly submitted to woodardp@wustl.edu.
Learn more about this trial
PET MYOCARDIAL Blood Flow Comparison to Coronary CTA and CT-FFR
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