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临床试验/ACTRN12622000436774
ACTRN12622000436774招募中未知

A multi-centre, prospective, non-randomised implementation study of incorporating a polygenic risk score into cardiovascular disease Examinations to identify SubClinicAL coronAry arTEry disease (The ESCALATE Study)

The University of Sydney0 个研究点目标入组 1,000 人开始时间: 2022年3月18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
1,000

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
Non-randomised trial
主要目的
Diagnosis

入排标准

年龄范围
45 Years 至 65 Years(—)
性别
All

入选标准

  • Males aged 45 to 60 years old
  • - Females aged 50 to 65 years old
  • - Eligible for a Medicare rebated cardiovascular disease consultation with a GP, including Heart Health Check MBS Item Numbers 177 or 699
  • - Willingness to undergo the PRS and/or CACS interventions as indicated per the PPP-CAD clinical pathway
  • - At least one (1) prior clinical visit to the GP
  • - Willing and able to provide informed consent by self

排除标准

  • - Conditions placing the individual at clinically determined high risk of CVD, not requiring calculation of Absolute CVD Risk:
  • - Diabetes and age greater than 60 years
  • -Diabetes with microalbuminuria (greater than 20 mcg/min or UACR greater than 2.5 mg/mmol for males, greater than 3.5 mg/mmol for females)
  • - Moderate or severe chronic kidney disease (CKD) (persistent proteinuria or eGFR less than 45mL/min/1.73m2)
  • - Previous diagnosis of familial hypercholesterolaemia
  • - Systolic blood pressure (SBP) greater than or equal to 180mmHg or diastolic blood pressure (DBP) greater than or equal to 110mmHg
  • - Serum total cholesterol greater than 7.5mmol/L
  • - Symptomatic or previously documented CAD
  • - Previous CVD event, including angina, myocardial infarction (MI), percutaneous coronary intervention, coronary artery bypass grafting, ischaemic stroke, transient ischaemic attack, heart failure, or peripheral arterial disease.
  • - Prior mediastinal radiation exposure or therapy
  • - Prior medical diagnosis of rheumatoid arthritis (RA) or systemic lupus erythematosus (SLE)
  • - Patients highly dependent on medical care and unable to provide informed consent
  • - Unable or unwilling to participate in 12-month follow-up
  • - People with cognitive impairment, intellectual disability, or mental illness that prevent them from providing informed consent for themselves.

研究者

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