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Completed

NCT Number: NCT05286593

3D PET Myocardial Blood Flow and Rb82 Infusion Profiles

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.

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Key information

About this study

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:

  • Healthy volunteers
  • Clinical volunteers with risk factors and/or CAD
  • Volunteers with clinical infarcts.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Slow Infusion of Rubidium-82

Drug

Normal volunteers will receive weight based doses of Rb-82 infused as a slow infusion

Other names: 20 mls/min of Rubidium-82

Primary outcomes

  1. Resting and stress whole heart myocardial blood flow using the bolus infusion profile of Rubidium-82

    Time frame: 1 day

    resting and stress myocardial blood flow in cc/min/g

Secondary outcomes

  1. Resting and stress whole heart myocardial blood flow using the slow infusion profile of Rubidium-82

    Time frame: 1 Day

    resting and stress myocardial blood flow in cc/min/g

Sponsors and collaborators

Lead sponsor

Ochsner Health System

Other

Collaborators

  • Bracco Corporate

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 18, 2022
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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