NCT05286593

3D PET Myocardial Blood Flow and Rb82 Infusion Profiles

Quantification of Myocardial Blood Flow by 3D Positron Emission Tomography With High and Low Rate Rb82 Infusion Profiles

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Ochsner Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Normal Healthy Volunteers Without Chronic Medical Conditions
• Coronary Artery Disease
• Cardiac Risk Factors
• Myocardial Infarction

Interventions

Type	Name	Description
DRUG	Slow Infusion of Rubidium-82	Normal volunteers will receive weight based doses of Rb-82 infused as a slow infusion
DRUG	Slow Infusion of Rubidium-82	Clinical patients will receive weight based doses of Rb-82 infused as a slow infusion
DRUG	Slow Infusion of Rubidium-82	Infarct volunteers will receive weight based doses of Rb-82 infused as a slow infusion

Timeline

• Start date: 2021-12-28
• Primary completion: 2022-09-01
• Completion: 2022-09-30
• First posted: 2022-03-18
• Last updated: 2023-01-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study