Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2025-12-25 @ 11:15 PM
Study NCT ID:
NCT05286593
Status:
COMPLETED
Last Update Posted:
2023-01-18
First Post:
2021-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
3D PET Myocardial Blood Flow and Rb82 Infusion Profiles
Sponsor:
Ochsner Health System
Organization:
Study Overview
Official Title:
Quantification of Myocardial Blood Flow by 3D Positron Emission Tomography With High and Low Rate Rb82 Infusion Profiles
Status:
COMPLETED
Status Verified Date:
2023-01
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 investigators seek to test bolus infusions (50ml/min) vs. slow infusions (20 ml/min) of Rb-82 on metrics of coronary blood flow assessed on a modern 3D PET/CT.
Detailed Description:
As perfusion metrics in the healthy volunteers, patients with risk factors and/or coronary artery disease and in tissue with transmural myocardial infarctions has been well defined AND same day test-retest variability minutes apart using a bolus infusion is ±10%, the investigators shall test 3 hypotheses. The first hypothesis is repeated same day test-retest coefficient of variation (COV) of whole heart rMBF and sMBF acquired using a bolus infusion profile (50 mls/min) on a modern 3D PET scanner falls within ± 10%. The second hypothesis is repeated same day test-retest COV of whole heart rMBF and sMBF acquired using a slow infusion activity profile (20 mls/min) on a modern 3D PET scanner falls within ± 10%. The third hypothesis is COV of whole heart rMBF and sMBF between bolus and slow activity profiles is ± 10% where the bolus is considered the standard on a modern 3D PET scanner.
The investigators will test the different activity profiles on 3 distinct populations:
1. Healthy volunteers
2. Clinical volunteers with risk factors and/or CAD
3. Volunteers with clinical infarcts.
The investigators will test the different activity profiles on 3 distinct populations:
1. Healthy volunteers
2. Clinical volunteers with risk factors and/or CAD
3. Volunteers with clinical infarcts.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: