3D PET Myocardial Blood Flow and Rb82 Infusion Profiles

Phase 4

Completed

• Conditions: Coronary Artery Disease; Cardiac Risk Factors; Normal Healthy Volunteers Without Chronic Medical Conditions; Myocardial Infarction
• Interventions: Drug: Slow Infusion of Rubidium-82

• Registration Number: NCT05286593
• Lead Sponsor: Ochsner Health System

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.

Study Timeline

• Study Start: 2021-12-28
• Study First Submitted: 2021-12-29
• Study First Submitted QC: 2022-03-09
• Study First Posted: 2022-03-18
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-16
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

Normal Volunteers

• Adults ≥18 and <40 years old able to give informed consent.
• Ability to abstain from caffeine for 48 hours

The "clinical" population

• Adults ≥18 years old able to give informed consent.
• Any cardiac risk factor including hypertension, hyperlipidemia, diabetes mellitus or tobacco use OR
• CAD defined by with history of PCI or CABG, Coronary Ca score>400, or dense coronary calcifications noted on chest CT
• Ability to abstain from caffeine for 48 hours

The "infarct" population

• Adults ≥18 years old able to give informed consent.

• Prior cardiac PET scan demonstrating a fixed defect ≥ 15% of the LV myocardium with relative uptake ≤60% maximum uptake.

• In addition, to the perfusion defect, each volunteer requires either:

  • FDG PET or MRI viability studies confirming infarct OR
  • akinesis and wall thinning on ECHO within the same territory as the PET defect in addition to Q-waves on ECG

• Ability to abstain from caffeine for 48 hours

Exclusion Criteria

Normal Volunteers

• Any chronic cardiac disease or condition (e.g., hypertension, hyperlipidemia)
• Any chronic systemic disease or condition (e.g., diabetes, systemic lupus, rheumatoid arthritis)
• Tobacco use
• Family history in a first degree relative with clinical CAD (h/o PCI, MI or CABG) in men <55 or women <65
• Severe claustrophobia
• Positive urine pregnancy test
• Inability to give informed consent
• BMI ≥ 30 or BMI>25 and <30 provided waist to hip ratio >0.80 in women or 0.90 in men.

The "clinical" and "infarct" populations

• Severe claustrophobia
• Hemodynamic instability or unstable symptoms
• Positive urine pregnancy test
• Inability to give informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Clinical patients	Slow Infusion of Rubidium-82	Clinical patients participants will receive serial doses of Rb-82 administered as either a bolus (B) (gold standard) or slow infusion (SI). Under resting conditions, they will receive 3 weight based doses. The first two doses are randomly assigned B and SI. The third dose is either B or SI. Under stress conditions, they will receive 2 weight based doses that are randomly assigned B and SI.
Infarcts	Slow Infusion of Rubidium-82	Infarct participants will receive serial doses of Rb-82 administered as either a bolus (B) (gold standard) or slow infusion (SI). Under resting conditions, they will receive 3 weight based doses. The first two doses are randomly assigned B and SI. The third dose is either B or SI. Under stress conditions, they will receive 2 weight based doses that are randomly assigned B and SI.
Normal volunteers	Slow Infusion of Rubidium-82	Normal participants will receive serial doses of Rb-82 administered as either a bolus (B) (gold standard) or slow infusion (SI). Under resting conditions, they will receive 3 weight based doses. The first two doses are randomly assigned B and SI. The third dose is either B or SI. Under stress conditions, they will receive 2 weight based doses that are randomly assigned B and SI.

Primary Outcome Measures

Name	Time	Method
Resting and stress whole heart myocardial blood flow using the bolus infusion profile of Rubidium-82	1 day	resting and stress myocardial blood flow in cc/min/g

Secondary Outcome Measures

Name	Time	Method
Resting and stress whole heart myocardial blood flow using the slow infusion profile of Rubidium-82	1 Day	resting and stress myocardial blood flow in cc/min/g

Trial Locations

Locations (1)

Ochsner; 🇺🇸 New Orleans, Louisiana, United States