Optimal Evaluation to Reduce Cardiovascular Imaging Testing

Not Applicable

Recruiting

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

Brief Summary: 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).

Detailed 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
NICE strategy	2016 NICE guideline-determined diagnostic strategy	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.
ESC strategy	2019 ESC guideline-determined diagnostic strategy	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.

Primary Outcome Measures

Name	Time	Method
CCTA without obstructive CAD	Through the initial management, an average of 2-5 days	The summary of nonobstructive CAD, no sign of CAD and nondiagnostic result detected by CCTA according to each strategy

Secondary Outcome Measures

Name	Time	Method
Myocardial infarction	1 year	Myocardial infarction was defined and classified as spontaneous or coronary procedure-related MI according to the Fourth Universal Definition of Myocardial Infarction.
Exposure to radiation	1 year	All exposure to radiation related to CIT and other cardiovascular procedures.
Proportion of normal CCTA	Through the initial management, an average of 2-5 days
Proportion of necessary CCTA	Through the initial management, an average of 2-5 days
Cumulative proportion of patients receiving other CITs	1 year
Cumulative proportion of patients who had alteration in OMT based on results of CCTA	Thtough the initial management, an average of 2-5 days
All-cause death	1 year	Any death.
Procedural complications	1 year	All procedural complications related to CIT and other cardiovascular procedures.
MACE	1 year	All-cause death, myocardial infarction and hospitalization due to unstable angina.
Hospitalization due to unstable angina	1 year	An hospitalization event in which the final diagnosis was myocardial ischemia.
Cumulative proportion of patients receiving CR	1 year

Locations (4): Hebei Petrochina Central Hospital
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Lanfang, Hebei, China
Beijing Chaoyang Hospital
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Beijing, Beijing, China
Tianjin Chest Hospital
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Tianjin, China
Tianjin First Central Hospital
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Tianjin, Tianjin, China