Clinical trial NCT05640752: Optimal Evaluation to Reduce Cardiovascular Imaging Testing
Official title: Optimal Evaluation of Stable Chest Pain to Reduce Unnecessary Utilization of Cardiac Imaging Testing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Coronary Syndrome
Keywords: Stable Chest Pain
Pretest Probability
Coronary Computed Tomography Angiography
Diagnostic Strategy
Coronary Artery Disease
Lead sponsor: Tianjin Chest Hospital
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 800
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: CCTA without obstructive CAD
timeFrame: Through the initial management, an average of 2-5 days
Secondary outcomes:
measure: MACE
timeFrame: 1 year
measure: All-cause death
timeFrame: 1 year
measure: Myocardial infarction
timeFrame: 1 year
measure: Hospitalization due to unstable angina
timeFrame: 1 year
measure: Exposure to radiation
timeFrame: 1 year
measure: Procedural complications
timeFrame: 1 year
measure: Cumulative proportion of patients receiving other CITs
timeFrame: 1 year
measure: Cumulative proportion of patients receiving CR
timeFrame: 1 year
measure: Cumulative proportion of patients who had alteration in OMT based on results of CCTA
timeFrame: Thtough the initial management, an average of 2-5 days
measure: Proportion of normal CCTA
timeFrame: Through the initial management, an average of 2-5 days
measure: Proportion of necessary CCTA
timeFrame: Through the initial management, an average of 2-5 days
Other outcomes:
measure: The health-related quality of life assessment (SAQ)
timeFrame: 1 year
measure: The health-related quality of life assessment (EQ-5D)
timeFrame: 1 year
Locations:
city: Beijing
country: China
facility: Beijing Chaoyang Hospital
state: Beijing
city: Lanfang
country: China
facility: Hebei Petrochina Central Hospital
state: Hebei
city: Tianjin
country: China
facility: Tianjin First Central Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Chest Hospital
Study officials:
affiliation: Tianjin Chest Hospital
name: Jia Zhou, MD
role: PRINCIPAL_INVESTIGATOR
References: