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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PET-cCTA-cFFR | Other | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET-cCTA-cFFR | Diagnostic Test | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. CT-FFR was determined in the following myocardial segments: left anterior descending (LAD), left circumflex (LCx), and right coronary artery (RCA). The number of coronary artery stenoses as determined by CT (CT-FFR ≤ 0.8) was measured. | Day 1 - Day of Scan |
| Association Between Stress Myocardial Blood Flow (MBF) on PET and Coronary Artery Stenosis on CCTA | Association between N-13 Ammonia PET MBF (mL/g/min) during stress and presence or absence of coronary artery stenosis ≥ 50% diameter on CCTA as determined by measurement in each epicardial coronary artery. The MBF values during stress were categorized as normal or abnormal. Normal MBF is defined as >1.8 mL/g/min. MBF and percent diameter stenosis were determined in the following myocardial segments: left anterior descending (LAD), left circumflex (LCx), and right coronary artery (RCA). | Day 1 - Day of Scan |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of Myocardial Blood Flow (MBF) by PET to Fractional Flow Reserve (FFR) by CT. | Correlation of CT-FFR and N-13 Ammonia PET MBF (mL/g/min) during stress as determined by measurement in each epicardial coronary artery. Values were determined in the following myocardial segments: left anterior descending (LAD), left circumflex (LCx), and right coronary artery (RCA). | Day 1 - Day of Scan |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University | St Louis | Missouri | 63110 | United States |
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.
Beginning 3 months and ending 10 years following article publication.
Proposals should be directly submitted to woodardp@wustl.edu.
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| ID | Title | Description |
|---|---|---|
| FG000 | PET-cCTA-cFFR | Patients presenting with stable angina and a moderate pretest likelihood for coronary artery disease (CAD) who are already scheduled to undergo invasive coronary catheterization (ICA) for the clinical indication of angina will be recruited to undergo a Coronary CT Angiography (cCTA) examination with Fractional Flow Reserve (FFR) followed immediately by regadenoson stress-rest N-13 Ammonia Positron Emission Tomography (PET) on the same PET/CT scanner. Patients will undergo their clinically scheduled ICA with FFR within 2 weeks of the imaging procedures. Patients will receive two single intravenous injections of 10-12 mCi each of the PET radiotracer N-13 Ammonia, one during rest and one during stress. Stress imaging will occur 30-40 minutes prior to rest imaging. Patients will undergo PET/CT imaging immediately post N-13 Ammonia injection. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | PET-cCTA-cFFR | Patients presenting with stable angina and a moderate pretest likelihood for coronary artery disease (CAD) who are already scheduled to undergo invasive coronary catheterization (ICA) for the clinical indication of angina will be recruited to undergo a Coronary CT Angiography (cCTA) examination with Fractional Flow Reserve (FFR) followed immediately by regadenoson stress-rest N-13 Ammonia Positron Emission Tomography (PET) on the same PET/CT scanner. Patients will undergo their clinically scheduled ICA with FFR within 2 weeks of the imaging procedures. Patients will receive two single intravenous injections of 10-12 mCi each of the PET radiotracer N-13 Ammonia, one during rest and one during stress. Stress imaging will occur 30-40 minutes prior to rest imaging. Patients will undergo PET/CT imaging immediately post N-13 Ammonia injection. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. CT-FFR was determined in the following myocardial segments: left anterior descending (LAD), left circumflex (LCx), and right coronary artery (RCA). The number of coronary artery stenoses as determined by CT (CT-FFR ≤ 0.8) was measured. | One participant did not undergo imaging. Radiotracer production failed. Patient received an intervention so did not qualify to come back. | Posted | Count of Units | Coronary arteries | Day 1 - Day of Scan | Coronary arteries | Coronary arteries |
|
Within 1-3 days following the imaging procedures and between 25-30 days after invasive coronary artery (ICA) catheterization
Study staff contacted participants by phone following the imaging procedures and invasive coronary artery (ICA) catheterization to confirm the subject's well-being and to ascertain if an adverse event occurred. Subjects received a phone call within 1-3 days following the imaging procedures and between 25-30 days after invasive coronary artery (ICA) catheterization.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PET-cCTA-cFFR | Patients presenting with stable angina and a moderate pretest likelihood for coronary artery disease (CAD) who are already scheduled to undergo invasive coronary catheterization (ICA) for the clinical indication of angina will be recruited to undergo a Coronary CT Angiography (cCTA) examination with Fractional Flow Reserve (FFR) followed immediately by regadenoson stress-rest N-13 Ammonia Positron Emission Tomography (PET) on the same PET/CT scanner. Patients will undergo their clinically scheduled ICA with FFR within 2 weeks of the imaging procedures. Patients will receive two single intravenous injections of 10-12 mCi each of the PET radiotracer N-13 Ammonia, one during rest and one during stress. Stress imaging will occur 30-40 minutes prior to rest imaging. Patients will undergo PET/CT imaging immediately post N-13 Ammonia injection. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Pamela K. Woodard | Washington University School of Medicine | 314-362-7100 | woodardp@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 1, 2021 | Jul 25, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| CT-Fractional Flow Reserve (CT-FFR) Global | CT-FFR was calculated using a computational flow/AI FFR program (Siemens). Normal CT-FFR was defined as >0.80. | Day 1 - Day of Scan |
| Instant Wave Free Ratio (iFR) | The instant wave Free Ratio (iFR) was measured during the patient's clinically scheduled invasive coronary catheterization. Normal iFR was defined as ≥ 0.90. | Day of invasive coronary catheterization - within 2 weeks of imaging |
| N-13 Ammonia PET Global Myocardial Blood Flow (MBF) Stress | Myocardial Blood Flow was measured by N-13 Ammonia positron emission tomography (PET) during stress following injection of regadenoson. | Day 1 - Day of Scan |
| N-13 Ammonia PET Global Myocardial Blood Flow (MBF) Rest | Myocardial Blood Flow (MBF) was measured by N-13 Ammonia positron emission tomography (PET) at rest. | Day 1 - Day of Scan |
| N-13 Ammonia PET Global Myocardial Flow Reserve (MFR) | Myocardial flow reserve (MFR) is a ratio between myocardial blood flow (MBF) during stress and at rest, as determined by positron emission tomography (PET). Normal MFR was defined as > 2.0. | Day 1 - Day of Scan |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Hypertension | Count of Participants | Participants |
|
| Smoking | Count of Participants | Participants |
|
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| Primary | Association Between Stress Myocardial Blood Flow (MBF) on PET and Coronary Artery Stenosis on CCTA | Association between N-13 Ammonia PET MBF (mL/g/min) during stress and presence or absence of coronary artery stenosis ≥ 50% diameter on CCTA as determined by measurement in each epicardial coronary artery. The MBF values during stress were categorized as normal or abnormal. Normal MBF is defined as >1.8 mL/g/min. MBF and percent diameter stenosis were determined in the following myocardial segments: left anterior descending (LAD), left circumflex (LCx), and right coronary artery (RCA). | One participant did not undergo imaging. Radiotracer production failed. Patient received an intervention so did not qualify to return for imaging. | Posted | Count of Units | Coronary arteries | Day 1 - Day of Scan | Coronary arteries | Coronary arteries |
|
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|
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| Secondary | Correlation of Myocardial Blood Flow (MBF) by PET to Fractional Flow Reserve (FFR) by CT. | Correlation of CT-FFR and N-13 Ammonia PET MBF (mL/g/min) during stress as determined by measurement in each epicardial coronary artery. Values were determined in the following myocardial segments: left anterior descending (LAD), left circumflex (LCx), and right coronary artery (RCA). | One participant did not undergo imaging. Radiotracer production failed. Patient received an intervention so did not qualify to return for imaging. | Posted | Number | Pearson correlation coefficient (r) | Day 1 - Day of Scan | Coronary arteries | Coronary arteries |
|
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| Secondary | CT-Fractional Flow Reserve (CT-FFR) Global | CT-FFR was calculated using a computational flow/AI FFR program (Siemens). Normal CT-FFR was defined as >0.80. | One participant did not undergo imaging. Radiotracer production failed. Patient received an intervention so did not qualify to come back. | Posted | Mean | Standard Deviation | Ratio | Day 1 - Day of Scan |
|
|
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| Secondary | Instant Wave Free Ratio (iFR) | The instant wave Free Ratio (iFR) was measured during the patient's clinically scheduled invasive coronary catheterization. Normal iFR was defined as ≥ 0.90. | iFR was done for 8 coronary arteries in 7 participants. | Posted | Mean | Standard Deviation | Ratio | Day of invasive coronary catheterization - within 2 weeks of imaging | Coronary arteries | Coronary arteries |
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| Secondary | N-13 Ammonia PET Global Myocardial Blood Flow (MBF) Stress | Myocardial Blood Flow was measured by N-13 Ammonia positron emission tomography (PET) during stress following injection of regadenoson. | One participant did not undergo imaging. Radiotracer production failed. Patient received an intervention so did not qualify to come back. | Posted | Mean | Standard Deviation | mL/g/min | Day 1 - Day of Scan |
|
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| Secondary | N-13 Ammonia PET Global Myocardial Blood Flow (MBF) Rest | Myocardial Blood Flow (MBF) was measured by N-13 Ammonia positron emission tomography (PET) at rest. | One participant did not undergo imaging. Radiotracer production failed. Patient received an intervention so did not qualify to come back. | Posted | Mean | Standard Deviation | mL/g/min | Day 1 - Day of Scan |
|
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| Secondary | N-13 Ammonia PET Global Myocardial Flow Reserve (MFR) | Myocardial flow reserve (MFR) is a ratio between myocardial blood flow (MBF) during stress and at rest, as determined by positron emission tomography (PET). Normal MFR was defined as > 2.0. | One participant did not undergo imaging. Radiotracer production failed. Patient received an intervention so did not qualify to come back. | Posted | Mean | Standard Deviation | Ratio | Day 1 - Day of Scan |
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| Normal MBF Stress |
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| Diameter Stenosis <50% |
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| Participants with Abnormal CT-FFR |
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| Participants with Abnormal MFR |
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