Assessment of Cardiac Function Using Combined Cardiovascular Magnetic Resonance and Cardiopulmonary Exercise Testing (CMR-CPET)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Heart rate (bpm) from MRI ECG/heart rate monitor
研究概览
简要总结
What problems limit patients' response to exercise? Using exercise cardiac magnetic resonance imaging to assess the heart's response, with simultaneous measurement of respiratory oxygen and carbon dioxide levels to assess the lung and skeletal muscle responses, to identify the rate-limiting factors affecting different types of patient
详细描述
Background and study aims Many medical conditions that affect the heart and lungs can cause breathlessness. People affected by breathlessness often require a number of tests to diagnose the medical condition responsible for their symptoms.
Cardiac MRI (magnetic resonance) scanning is already used to help diagnose and monitor patients with heart conditions (for example cardiomyopathy and pulmonary hypertension). By exercising while having an MRI scan, and at the same time measuring the gases breathed in and out from the air, it will be possible to more accurately understand the changes that occur in the heart, lungs and muscles.
The purpose of this study is to develop our understanding of the cardiovascular response to exercise in patients with non-ischaemic cardiomyopathy.
Who can participate? Patients aged 18 - 80 years with symptoms of breathlessness on exertion, and under the care of cardiology, pulmonary hypertension or rheumatology clinics for non-ischaemic cardiovascular disease.
What does the study involve? Participants will be invited to an appointment at the cardiovascular MRI department at the Royal Free Hospital. On the day of the appointment, participants will be welcomed to the department by the research team and the researchers will check that participants are well enough to exercise and safe to have an MRI scan. There will be an opportunity to ask any further questions.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years
- •Symptoms of breathlessness on exertion under the care of cardiology, pulmonary hypertension or rheumatology clinics for non-ischaemic cardiovascular disease
- •Willing and able to provide written informed consent
排除标准
- •Previous ischaemic heart disease (including angina, myocardial infarction, PCI, CABG)
- •Unstable symptoms (including crescendo angina or angina at rest, and syncope on exercise)*
- •Arrhythmia**
- •Musculoskeletal disease preventing exercise
- •Patients unable to provide consent
- •General contraindications to CMR (e.g. implanted metal objects, pregnancy, severe claustrophobia)
- •Significant parenchymal lung disease (defined as >20% extent parenchymal disease on CT)
- •WHO functional class IV symptoms *Patients with unstable symptoms have been excluded as it would be unsafe for them to perform exercise whilst in a MRI scanner. Patients unable to exercise, WHO functional class IV and those with significant lung disease have been excluded as they would be unable to complete the exercise protocol **The researchers have excluded patients with arrhythmia as this can reduce the reliability of some of the CMR image sequences and also results in less predictable heart rate response to exercise
结局指标
主要结局
Heart rate (bpm) from MRI ECG/heart rate monitor
时间窗: Change from Baseline at 3 months
Heart rate (bpm) from MRI ECG/heart rate monitor measured at rest, at 2 minutes intervals during exercise, at 2 minutes and 4 minutes after end of exercise
Blood pressure (mmHg) from MRI-compatible BP monitor
时间窗: Change from Baseline at 3 months
Blood pressure (mmHg) from MRI-compatible BP monitor measured at rest, at 2 minutes intervals during exercise, at 2 minutes and 4 minutes after end of exercise
Ventricular volumes (mL) measured using volumetric measurements of both ventricles, at end-diastole and end-systole
时间窗: Change from Baseline at 3 months
Ventricular volumes (mL) measured using volumetric measurements of both ventricles, at end-diastole and end-systole measured at rest, at 2 minutes intervals during exercise, at 2 minutes and 4 minutes after end of exercise
Oxygen consumption (VO2, mL/min) from CPET machine
时间窗: Change from Baseline at 3 months
Oxygen consumption (VO2, mL/min) from CPET machine measured at rest, at 2 minutes intervals during exercise, at 2 minutes and 4 minutes after end of exercise
Respiratory exchange ratio (RER) from CPET machine
时间窗: Change from Baseline at 3 months
Respiratory exchange ratio (RER) from CPET machine measured at rest, at 2 minutes intervals during exercise, at 2 minutes and 4 minutes after end of exercise
Carbon dioxide production (VCO2, mL/min) from CPET machine
时间窗: Change from Baseline at 3 months
Carbon dioxide production (VCO2, mL/min) from CPET machine measured at rest, at 2 minutes intervals during exercise, at 2 minutes and 4 minutes after end of exercise
Cardiac output (L/min) measured using aortic flow from PCMR measurements
时间窗: Change from Baseline at 3 months
Cardiac output (L/min) measured using aortic flow from PCMR measurements measured at rest, at 2 minutes intervals during exercise, at 2 minutes and 4 minutes after end of exercise
Arteriovenous Oxygen Gradient (Muscle oxygen consumption, mlO2/100mL blood/min) calculated from Cardiac Output and VO2
时间窗: Change from Baseline at 3 months
Arteriovenous Oxygen Gradient (Muscle oxygen consumption, mlO2/100mL blood/min) measured at rest, at 2 minutes intervals during exercise, at 2 minutes and 4 minutes after end of exercise calculated from Cardiac Output and VO2
Exercise duration (sec) measured using a timer from the start to the end of exercise
时间窗: Change from Baseline at 3 months
Exercise duration (sec) measured using a timer from the start to the end of exercise measured at rest, at 2 minutes intervals during exercise, at 2 minutes and 4 minutes after end of exercise
次要结局
- N-terminal pro-BNP (ng/L) measured using blood sample prior to scan(through study completion, an average of 1 year)
- Haemoglobin (g/L) measured using blood sample prior to scan(through study completion, an average of 1 year)
- Mortality measured using patient records(Change from baseline at 6 months)
- Cardiac Troponin T (ng/L) measured using blood sample prior to scan(through study completion, an average of 1 year)
- PH disease progression (WHO Functional class) measured using patient records(Change from baseline at 6 months)
- Autoantibody profile measured using blood sample prior to scan(through study completion, an average of 1 year)
- Invasive pulmonary pressures (PA systolic/diastolic/mean) in MR-RHC substudy measured using a pressure transducer at rest and after 1 min of exercise(through study completion, an average of 1 year)