Quantification of Myocardial Blood Flow by 3D Positron Emission Tomography With High and Low Rate Rb82 Infusion Profiles
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Resting and stress whole heart myocardial blood flow using the bolus infusion profile of Rubidium-82
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Normal volunteers
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.
干预措施: Slow Infusion of Rubidium-82 (Drug)
Clinical patients
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.
干预措施: Slow Infusion of Rubidium-82 (Drug)
Infarcts
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.
干预措施: Slow Infusion of Rubidium-82 (Drug)
结局指标
主要结局
Resting and stress whole heart myocardial blood flow using the bolus infusion profile of Rubidium-82
时间窗: 1 day
resting and stress myocardial blood flow in cc/min/g
次要结局
- Resting and stress whole heart myocardial blood flow using the slow infusion profile of Rubidium-82(1 Day)
研究者
Robert Bober, M.D.
Director of Nuclear Cardiology
Ochsner Health System