Comparison of Dobutamine and Regadenoson Stress CMR
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Duration of Procedures
研究概览
简要总结
The goal of this research is to determine the utility of Regadenoson (Lexiscan)for use as an imaging agent with cardiac MR. If found useful, it will help us establish a protocol for regadenoson stress MR perfusion (Regadenoson stress test with cardiac MR).The investigators will compare regadenoson with dobutamine so each participant will undergo two studies. A cardiac MR stress test with regadenoson and with dobutamine. The investigators participants will include patients with history of COPD and Asthma, so it will also help us determine feasibility of Regadenoson in these patient's subgroups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 40 to 85 years with OBSTRUCTIVE AIRWAY DISEASES (ASTHMA AND COPD) and a forced expiratory volume (FEV1) > 0.
- •Patients should have a clinical indication to undergo cardiac stress test with dobutamine.
排除标准
- •Those with pacemakers, defibrillators, functioning neural stimulator devices or other implanted electronic devices.
- •Ferromagnetic cerebral aneurism clips or other intraorbital and intracranial metal.
- •An allergy to Gadolinium or other severe drug allergies.
- •Acute myocardial infarction within 3 months.
- •Moderate or severe aortic stenosis or other significant valvular disease;
- •Claustrophobia.
- •High grade (2o or 3o) AV Block.
- •Closed angle glaucoma.
- •Participants unable to provide informed consent.
- •Renal dialysis (subjects with moderate-to-severe renal impairment defined as eGFR < 60 mL/min.
- •A contraindication to receipt of dobutamine.
- •Participants with known coronary artery disease will be included with the exception that patients with left main or narrowings >50% in the distributions of the left anterior descending, circumflex, and right coronary artery will be excluded.
研究组 & 干预措施
A
Arm A will get Dobutamine Stress test with cardiac MR (CMR). Both arms will then cross over to the other arm to get the second test. So each participant will undergo two types of testing.
干预措施: Regadenoson (Drug)
A
Arm A will get Dobutamine Stress test with cardiac MR (CMR). Both arms will then cross over to the other arm to get the second test. So each participant will undergo two types of testing.
干预措施: Dobutamine (Drug)
B
Arm B will get Regadenoson stress test with CMR. Both arms will then cross over to the other arm to get the second test. So each participant will undergo two types of testing.
干预措施: Regadenoson (Drug)
B
Arm B will get Regadenoson stress test with CMR. Both arms will then cross over to the other arm to get the second test. So each participant will undergo two types of testing.
干预措施: Dobutamine (Drug)
结局指标
主要结局
Duration of Procedures
时间窗: 1 day
To compare the time involved during pharmacologic stress testing using regadenoson versus intravenous dobutamine in individuals with moderate to severe chronic obstructive pulmonary disease (COPD)or asthma.
次要结局
- Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire(1 day)
- Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare MD Questionnaire (Episodes of Arrhythmias, Bradycardia, and Wheezing)(1 day)
- Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Tech Questionnaire(1 day)
- Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Tech Questionnaire (Episodes of Wheezing)(1 day)
- Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire(1 day)
- Ease of Administration of Regadenoson Versus Intravenous Dobutamine Using Compare Nurse Questionnaire (Episodes of Arrhythmias, Bradycardia, Hypertension, and Wheezing)(1 day)