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临床试验/ACTRN12622000316707
ACTRN12622000316707招募中未知

Secondary Prevention for All in Need (SPAN) after Type 1 myocardial infarction: a comparative effectiveness randomised trial

The University of Western Australia0 个研究点目标入组 650 人开始时间: 2022年2月21日最近更新:

试验速览

阶段
未知
状态
招募中
入组人数
650

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
Prevention
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • Persons aged at least 18 years;
  • Inpatient diagnosis of suspected ST-segment elevation MI (STEMI), or high-risk and intermediate-risk non-STEMI (NSTEMI) acute coronary syndrome by ACS Guidelines and 4th universal definition of MI. Specifically, Troponin Pattern 1 (Acute Myocardial Injury): A rise and/or fall in troponin from at least 2 samples defined as: (1) Hs-Troponin T: A rise and/or fall in the absolute troponin level of >2.5ng/L/hour (ie a change of >15ng/L in 6 hours) between any troponin results before randomisation OR a relative change in troponin >20% between earlier and later samples (ie 100*(hs-TnT[later] - hs-TnT[earlier] / hs-TnT[earlier]) >20%) documented on any troponin results before randomisation. (2) Hs-Troponin I: An absolute elevation of >10 times the upper limit of normal specific for that assay, using gender-specific cut-points if implemented locally OR change in troponin >20% between earlier and later samples (ie 100*(hs-TnI[later] - hs-TnI[earlier] / hs-TnI[earlier]) >20% documented on any troponin results before randomisation;
  • Regarded by the treating cardiologist to be suitable for cardiac rehabilitation.

排除标准

  • Prior cardiac rehabilitation;
  • Clinical diagnosis of uncompensated severe heart failure (Class IV);
  • Uncontrolled arrhythmia or angina;
  • Severe or symptomatic aortic stenosis;
  • Co-existing clinical diagnosis of non-cardiac condition that would prevent participation (eg advanced dementia, severe rheumatoid arthritis, severe frailty, terminal illness).

研究者

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