Optimal Evaluation to Reduce Cardiovascular Imaging Testing

Официальное название

Optimal Evaluation of Stable Chest Pain to Reduce Unnecessary Utilization of Cardiac Imaging Testing

Обзор

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).

Подробное описание

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.

Вмешательства

• Диагностический тест 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
• Диагностический тест 2016 NICE guideline-determined diagnostic strategy
  For subjects assigned to NICE strategy, ones with nonanginal chest pain and normal ECG were classified into low risk group and ones with typical and atypical angina or nonanginal chest pain with abnormal ECG were classified into high risk group. Subjects determined to be at low risk will be referred to optimal medication treatment with no immediate CCTA.

Первичные конечные точки

• CCTA without obstructive CAD [Срок оценки: Through the initial management, an average of 2-5 days]

Вторичные конечные точки (11)

• MACE [Срок оценки: 1 year]
• All-cause death [Срок оценки: 1 year]
• Myocardial infarction [Срок оценки: 1 year]
• Hospitalization due to unstable angina [Срок оценки: 1 year]
• Exposure to radiation [Срок оценки: 1 year]
• Procedural complications [Срок оценки: 1 year]
• Cumulative proportion of patients receiving other CITs [Срок оценки: 1 year]
• Cumulative proportion of patients receiving CR [Срок оценки: 1 year]
• Cumulative proportion of patients who had alteration in OMT based on results of CCTA [Срок оценки: Thtough the initial management, an average of 2-5 days]
• Proportion of normal CCTA [Срок оценки: Through the initial management, an average of 2-5 days]
• Proportion of necessary CCTA [Срок оценки: Through the initial management, an average of 2-5 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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
• Complex structural heart disease
• Non-cardiac illness with life expectancy < 2 years
• Allergy to iodinated contrast agent
• Estimated glomerular filtration rate<60 ml/min/1.73m2 within 90 days
• Body mass index >35kg/m2
• Expressing a clear preference for undergoing CIT or not
• Pregnancy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Диагностика

Центры проведения

Китай · 4 центра

• Beijing Chaoyang Hospital — Пекин
• Hebei Petrochina Central Hospital — Lanfang
• Tianjin First Central Hospital — Тяньцзинь
• Tianjin Chest Hospital — Тяньцзинь

Публикации

• Zhou J, Xin T, Tan Y, Pang J, Chen T, Wang H, Zhao J, Liu C, Xie C, Wang M, Wang C, Liu Y, Zhang J, Liu Y, Shanfu C, Li C, Cong H. Comparison of two diagnostic strategies for patients with stable chest pain suggestive of chronic coronary syndrome: rationale and design of the double-blind, pragmatic, randomized and controlled OPERATE Trial. BMC Cardiovasc Disord. 2023 Aug 23;23(1):416. doi: 10.1186 PMID 37612631

Идентификаторы

NCT: NCT05640752 · 2022KY-024-01 · 62206197 · TJWJ2022QN067 · 21JCYBJC00820

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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