Optimal Evaluation to Reduce Cardiovascular Imaging Testing

Not Applicable

Recruiting

• Conditions: Chronic Coronary Syndrome

• Registration Number: NCT05640752
• Lead Sponsor: Tianjin Chest Hospital

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.

Study Timeline

• Study First Submitted: 2022-11-27
• Study First Submitted QC: 2022-12-05
• Study First Posted: 2022-12-07
• Study Start: 2023-12-11
• Status Verified: 2024-12
• Primary Completion: 2024-12-11
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-24
• Study Completion: 2025-12-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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

Trial Locations

Locations (4)

Beijing Chaoyang Hospital; 🇨🇳 Beijing, Beijing, China

Hebei Petrochina Central Hospital; 🇨🇳 Lanfang, Hebei, China

Tianjin First Central Hospital; 🇨🇳 Tianjin, Tianjin, China

Tianjin Chest Hospital; 🇨🇳 Tianjin, China