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临床试验/ACTRN12622000731796
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.

The University of Sydney0 个研究点目标入组 58 人开始时间: 2022年5月20日最近更新:
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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