ACTRN12622000731796招募中未知
A micro randomised trial (MRT) to test the effects of app-based motivational messages on physical activity and on heart rate via smartphone app compliance in patients with vulnerable coronary artery plaques.
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 58
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •1.Intervention group participants from the LIVEPLUS study (ANZCTR registration: ACTRN12620001151921).
- •2.Adults who can competently use a smartphone (running iOS or Android)
- •3.Presence of Low attenuation plaque on Coronary Computed Tomography Angiography
- •4.18-80 years of age
- •5.BMI greater than or equal to 22.0 kg/m2
- •6.Have no contraindications for the LIVEPLUS study
- •7.Able to give full informed consent
排除标准
- •People from the Control group participants from the LIVEPLUS study (ANZCTR registration: ACTRN12620001151921) will be excluded.
- •Additional exclusion criteria for the parent LIVEPLUS study are as follows:
- •1. History or clinical manifestation of any other significant metabolic, hematologic, pulmonary, cardio- vascular, gastrointestinal, neurologic, immune, hepatic, renal, urologic disorders, or cancer that, in opinion of the investigator, would make the candidate ineligible for the study
- •2.Non-MRI-compatible implanted devices or implants
- •3.Estimated glomerular filtration rate (eGFR) less than 30mL/kg/1.73m2
- •4.Inability to exercise via supine ergometer
- •5.Claustrophobia
- •6.Contraindications for adenosine: Sinus node disease (e.g. sick sinus syndrome, symptomatic sinus bradycardia), second- or third- degree heart blocks, unstable angina, bronchospasm (e.g. asthma), heart transplant recipient, history of seizure disorder
- •7.Contraindications for glyceryl trinitrate: Known nitrate hypersensitivity, severe anaemia, severe aortic or mitral stenosis, hypotension defined as resting systolic blood pressure equal to 89 mmHg.
- •8.Not suitable for CT coronary angiography due to contraindications
- •9.Psychiatric or behavioural problems (history of drug and alcohol abuse, eating disorder)
- •10.Breast feeding or pregnant women, or those intending to become pregnant before the scheduled end of the intervention
- •11.Concurrent participation in any other interventional study.
研究者
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