Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05885841
Status:
COMPLETED
Last Update Posted:
2023-06-02
First Post:
2022-12-25
Brief Title:
Evaluation of XTR004 as a Novel 18F-labeled PET MPI Tracer in Diagnosis of Known or Suspected CAD
Sponsor:
Sinotau Pharmaceutical Group
Organization:
Sinotau Pharmaceutical Group
Study Overview
Official Title:
Evaluation of XTR004 as a Novel 18F-labeled PET Myocardial Perfusion Imaging MPI Tracer in Diagnosis of Known or Suspected CAD Compared With Invasive Coronary Angiography Fractional Flow Reserve Index of Microcirculatory Resistance
Status:
COMPLETED
Status Verified Date:
2023-05
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 diagnostic efficacy and safety of the XTR004 myocardial perfusion PET imaging tracer are evaluated for known or suspected CAD with the use of invasive coronary angiography as the reference standard for the diagnosis of CAD and invasive pressure-temperature FFRIMR as a reference for the detection of abnormal coronary function
Detailed Description:
A phase II study that is single-arm open-label multi-center and self-controlled with the following objectives
1 Quantitative diagnostic efficacy of XTR004 perfusion imaging tracer in the diagnosis of known or suspected CAD using invasive coronary angiography as a reference standard for CAD
2 The effectiveness of XTR004 myocardial perfusion imaging tracer in the detection of CAD using a pressure-temperature guide wire fractional flow reserve FFR and index of microcirculation resistance IMR as a reference standard to confirm abnormal coronary blood flow reserve and microvascular disfunction
3 Subjects safety after two doses of XTR004 intravenous injection
1 Quantitative diagnostic efficacy of XTR004 perfusion imaging tracer in the diagnosis of known or suspected CAD using invasive coronary angiography as a reference standard for CAD
2 The effectiveness of XTR004 myocardial perfusion imaging tracer in the detection of CAD using a pressure-temperature guide wire fractional flow reserve FFR and index of microcirculation resistance IMR as a reference standard to confirm abnormal coronary blood flow reserve and microvascular disfunction
3 Subjects safety after two doses of XTR004 intravenous injection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None