Optimal Evaluation to Reduce Cardiovascular Imaging Testing (OPERATE)

Tianjin Chest Hospital

Status: Enrolling

Conditions: Chronic Coronary Syndrome

Treatments: Diagnostic Test: 2019 ESC guideline-determined diagnostic strategy; Diagnostic Test: 2016 NICE guideline-determined diagnostic strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT05640752

TJWJ2022QN067 (Other Grant/Funding Number)

21JCYBJC00820 (Other Grant/Funding Number)

62206197 (Other Grant/Funding Number)

2022KY-024-01

Details and patient eligibility

About

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).

Full description

OPERATE trial was an investigator-initiated, multicenter, prospective, CCTA-based, 2-arm 1:1 parallel-group, double-blind and pragmatic RCT planned to include 800 subjects with SCP suggestive of CCS. Subjects were assigned randomly to two groups: 1) 2016 National Institutes for Clinical Excellence guidelines-determined diagnostic strategy (NICE strategy) and 2) 2019 European Society of Cardiology guidelines-determined diagnostic strategy (ESC strategy) The primary objective of OPERATE trial is to compare the rates of CCTA without obstructive CAD according to NICE and ESC strategy. The key secondary objective is to assess whether the two strategies have no significant difference in terms of major adverse cardiac events (MACE). The investigators hypothesize that when comparing with NICE strategy, ESC strategy which sequentially incorporated the ESC-PTP model with RF-CL model will decrease the probability of CCTA without obstructive CAD but not at the expense of safety and cost over a follow-up period of 1 year.

Enrollment: 800 estimated patients

Sex: All

Ages: 30 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

1. SCP or equivalenta suggestive of CCS and clinically stability
2. No history of CAD (prior myocardial infarction, CR or any CAD documented by previous CIT)
3. Age ≥30 years
4. Willing and able to provide informed consent

Exclusion criteria

1. Prior CIT within 1 year prior to randomization
2. Clinically instability (e.g. cardiogenic shock, ACS, severe arrhythmias or NYHA III or IV heart failure)
3. Non-sinus rhythm
4. Concomitant participation in another clinical trial
5. Complex structural heart disease
6. Non-cardiac illness with life expectancy < 2 years
7. Allergy to iodinated contrast agent
8. Estimated glomerular filtration rate<60 ml/min/1.73m2 within 90 days
9. Body mass index >35kg/m2
10. Expressing a clear preference for undergoing CIT or not
11. Pregnancy

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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800 participants in 2 patient groups

ESC strategy

Experimental group

Description:

ESC-PTP is calculated using age, sex and type of chest pain according to 2019 ESC guideline for the diagnosis and management of CCS and RF-CL is calculated using age, sex, type of chest pain, hypertension, dyslipidemia, diabetes, smoking and family history of CAD based on the publication of Winther et al., respectively. According to ESC strategy, subjects with ESC-PTP ≤5% are classified into low risk group and ones with ESC-PTP ≥15% are classified into high risk group. For subjects with ESC-PTP of 5%-15%, ones with RF-CL ≥15% are classified into high risk group and ones with RF-CL \<15% are classified into low risk group. CCTA should be referred for a subject in high risk group. Subjects determined to be at low risk will be referred to optimal medication treatment with no immediate CCTA.

Treatment:

Diagnostic Test: 2019 ESC guideline-determined diagnostic strategy

NICE strategy

Experimental group

Description:

According to NICE strategy, subjects with nonanginal chest pain and normal ECG are classified into low risk group and ones with typical and atypical angina or nonanginal chest pain with abnormal ECG are classified into high risk group. CCTA should be referred for a subject in high risk group. Subjects determined to be at low risk will be referred to optimal medication treatment with no immediate CCTA.

Treatment:

Diagnostic Test: 2016 NICE guideline-determined diagnostic strategy