Hyperemic mYocardial Perfusion by adEnosine at diffeRent Doses
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Myocardial hyperemia
研究概览
简要总结
Adenosine is a commonly used pharmaceutical stressor at cardiac magnetic resonance examinations to assess suspected chronic coronary syndrome (CCS). However, several studies have reported that the current use of adenosine does not induce adequate hyperemic response in a substantial number of patients, leading to false diagnostics. The aim of this trial is to investigate the hyperemic effect of the standard dose of adenosine (140 microgram/kg/min) to the high dose of adenosine (210 microgram/kg/min) to improve the diagnostic methods using adenosine as a stressor and ultimately improve treatment decisions and patient prognosis in CCS.
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 (Participant)
盲法说明
The subject will be blinded to the order of adenosine doses.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject has given their written consent to participate in the trial.
- •Are referred to Department of Clinical Physiology, Skåne University Hospital, for suspected or known CCS or heart failure
- •Matches the inclusion criteria for sex and age (6 females and 6 males from each group in each age decade from 40 to >80 years old)
- •Matches the inclusion criteria for no known heart failure (group b) or known heart failure (group c)
- •No caffein intake <24h prior to the examination
- •Healthy volunteers:
- •The subject has given their written consent to participate in the trial.
- •Matches the inclusion criteria for sex and age (6 females and 6 males from each group in each age decade from 40 to >80 years old)
- •No caffein intake <24h prior to the examination
排除标准
- •Acute referral (in-house patients)
- •Clinically unstable
- •Acute chest pain
- •Severe or decompensated heart failure
- •Non sinus rhythm (e.g. atrial fibrillation)
- •Asthma or severe chronic obstructive pulmonary disease
- •Known chronic renal failure (eGFR <45mL/min/1.73m2)
- •AV-block II or III
- •Left Bundle Branch Block
- •Systolic blood pressure <90 mmHg or >230 mmHg at rest
- •Increased intracranial pressure
- •Known allergy or adverse reaction to adenosine or mannitol
- •Known allergy or adverse reaction to gadolinium contrast agents
- •Treatment with medication containing dipyradimol or teofyllamin/teofyllin
- •Claustrophobia
- •Devices contraindicated to CMR imaging (pacemaker, implants, intracranial clips etc)
- •Pregnancy or breast feeding (screened by question only)
- •Inability to give informed consent due to mental state, language difficulties etc
- •Healthy volunteers:
- •Any of the exclusion criteria for patients
- •Blood pressure > 140/90 measured according to clinical routine
- •Known systemic disease
- •Known cardiac disease
- •Cardiovascular medication
- •Medication that might influence cardiovascular health
研究组 & 干预措施
Start standard dose adenosine followed by high dose adenosine
Subjects randomized to this arm will undergo the first stress perfusion acquisition with a dose of 140 μg/kg/min adenosine, followed by a second stress perfusion acquisition with the dose of 210 μg/kg/min adenosine.
干预措施: Adenosine (Drug)
Start high dose adenosine followed by standard dose adenosine
Subjects randomized to this arm will undergo the first stress perfusion acquisition with a dose of 210 μg/kg/min adenosine, followed by a second stress perfusion acquisition with the dose of 140 μg/kg/min adenosine.
干预措施: Adenosine (Drug)
结局指标
主要结局
Myocardial hyperemia
时间窗: During adenosine infusion, 4-6 minutes
The primary outcome measure is assessed by quantitative myocardial perfusion CMR imaging (ml/min/g).
次要结局
- Heart rate response(During adenosine infusion, 4-6 minutes)
- Blood pressure response(During adenosine infusion, 4-6 minutes)
- Symptoms(During adenosine infusion, 4-6 minutes)