Optimal Evaluation to Reduce Cardiovascular Imaging Testing

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-90
SponsorTianjin Chest Hospital

About this trial

In daily clinical routine, the evaluation of new-onset and stable chest pain (SCP) suggestive of chronic coronary syndrome (CCS) remains a challenge for physicians. Although coronary computed tomography angiography (CCTA) seems to be the first-line cardiac imaging testing (CIT) according to the recommendations from current guidelines, the optimal diagnostic strategy to identify low risk patients who may derive minimal benefit from further CIT is the cornerstone of clinical management for SCP. Recently, different diagnostic strategies were provided to effectively defer unnecessary CIT, but few studies have prospectively determined the actual effect of applying these strategies in clinical practice. Therefore, the OPERATE study was designed to compare the effectiveness and safety of two proposed diagnostic strategies in identification of low risk individual who may derive minimal benefit from CCTA among patients with SCP suggestive of CCS in a pragmatic randomized controlled trial (RCT).

Eligibility criteria

Qualifiers

SCP or equivalenta suggestive of CCS and clinically stability

No history of CAD (prior myocardial infarction, CR or any CAD documented by previous CIT)

Age ≥30 years

Willing and able to provide informed consent

Disqualifiers

Prior CIT within 1 year prior to randomization

Clinically instability (e.g. cardiogenic shock, ACS, severe arrhythmias or NYHA III or IV heart failure)

Non-sinus rhythm

Concomitant participation in another clinical trial

Trial design

Treatments tested in this trial

  • 2019 ESC guideline-determined diagnostic strategy
  • 2016 NICE guideline-determined diagnostic strategy

Treatment groups

800 Participants
are divided into 2 treatment groups

Sponsors and collaborators