3D PET Myocardial Blood Flow and Rb82 Infusion Profiles

Ochsner Health System

Status and phase: Completed; Phase 4

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

Treatments: Drug: Slow Infusion of Rubidium-82

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05286593

STUDY00001584

Details and patient eligibility

About

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.

Full 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.

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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98 participants in 3 patient groups

Normal volunteers

Other group

Description:

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.

Treatment:

Drug: Slow Infusion of Rubidium-82

Drug: Slow Infusion of Rubidium-82

Drug: Slow Infusion of Rubidium-82

Clinical patients

Other group

Description:

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.

Treatment:

Drug: Slow Infusion of Rubidium-82

Drug: Slow Infusion of Rubidium-82

Drug: Slow Infusion of Rubidium-82

Infarcts

Other group

Description:

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.

Treatment:

Drug: Slow Infusion of Rubidium-82

Drug: Slow Infusion of Rubidium-82

Drug: Slow Infusion of Rubidium-82