The Effect of Short-term Bed Rest on Cardiac Function Measured by Cardiac Magnetic Resonance Imaging
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- cardiac output
研究概览
简要总结
The primary objective of this study is to investigate the effect of short-term bed rest (4 hours) on heart function, measured by cardiac magnetic resonance (CMR), in healthy participants. This aim will be addressed through a single-arm repeated study, assessing participants during three hours of bedrest.
The hypothesis is that short-term bed rest will decrease cardiac output measured by repeated CMR scans.
This study will also investigate the reproducibility of CMR within a narrow time frame. Limited data are available on these aspects, despite their critical importance for conducting consecutive examinations, both in clinical practice and research trials10-12. The study also aims to investigate the appliances of short-time measures of cardiac function.
详细描述
The study will be conducted as a single-arm repeated measurement study in healthy participants (n=19). The participants will undergo a three and half-hour experimental day.
Initially, potential participants are invited to an information meeting and after informed consent, a control screening of MR contraindications is fulfilled. Following inclusion, the test day are conducted. The participants will arrive after a 4-hour period with no intake of food and drinks, except 250g of water, and by passive transportation (train, bus, or car). After arrival, a vein catheter is inserted into the antecubital vein. Then, a basal venous blood sample (-15 min) is drawn (4 ml in total) for analysis of plasma catecholamine and acetylcholine, and blood pressure is taken. Thereafter, the first basal CMRs will be performed with ECG monitoring.
During the test day, the participants will undergo five 15 min CMR imaging scans at 0, 30, 60, 120 and 180 mins. The first three are consecutive measurements with short breaks between, therefor the participants will lay in the scanner for the first 75 min and stay in bed in between the two sequential measurements. The participants will be in bedrest throughout the experimental day. Venous blood samples (4 ml) are obtained at 75, 110, and 170 min, where also blood pressure is taken. In total, up to 25 ml blood is obtained during the test day. The duration of the test day is 4.5 hour.
The time requirements for each participant are summarized:
- Information meeting and screening, approximately 1.5 hour
- 1 test day of approximately 4.5 hour.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- 是
入选标准
- •Male or female.
- •Age between 18-80 years old.
- •No use of medications with influence on heart function.
- •For ethical reasons, we only include participants who are willing to be informed on new health information, as CMR may reveal relevant secondary health findings.
排除标准
- •Diabetes, kidney, or liver disease.
- •Contraindications to CMR, e.g., abdominal height exceed limitations of the MR-scanner, pacemaker, aortastent, neurostimulator, or other electronic device implanted, implanted metal devices, severe claustrophobia, or physiological diseases.
- •Pregnant, lactating, or planning to become pregnant within the study period.
- •In ongoing cancer treatment.
- •Blood donation during and < 1 month prior to study.
- •Simultaneous participation in other clinical trials potentially affecting the study outcome.
- •Inability, physically or mentally, to comply with the procedure required by the study protocol ad evaluated by the primary investigator, study manager or clinical responsible.
研究组 & 干预措施
Cardiac magnetic resonance measurements
Healthy participants will undergo a three and half-hour experimental day including repeated measurements of cardiac magnetic resonance and blood sampling.
干预措施: Bedrest (Other)
结局指标
主要结局
cardiac output
时间窗: 0-4 hours
Change in cardiac output will be measured assessed by repeated cardiac magnetic resonance measurement after shortterm bed rest compared with before bedrest.
次要结局
- Left ventricular ejection fraction(0-4 hours)
研究者
Bente Kiens
Professor
University of Copenhagen