Ignite Creation Date:
2024-05-06 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05349084
Status:
COMPLETED
Last Update Posted:
2023-09-08
First Post:
2022-04-11
Brief Title:
PET MYOCARDIAL Blood Flow Comparison to Coronary CTA and CT-FFR
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
PET MYOCARDIAL Blood Flow Comparison to Coronary CTA and CT-FFR
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 PETCT 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None