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NCT Number: NCT05640752

Optimal Evaluation to Reduce Cardiovascular Imaging Testing

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).

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Key information

Conditions

Chronic Coronary Syndrome Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

30 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Chaoyang Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

2019 ESC guideline-determined diagnostic strategy

Diagnostic Test

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.

2016 NICE guideline-determined diagnostic strategy

Diagnostic Test

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.

Primary outcomes

  1. CCTA without obstructive CAD

    Time frame: 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 outcomes

  1. MACE

    Time frame: 1 year

    All-cause death, myocardial infarction and hospitalization due to unstable angina.

  2. All-cause death

    Time frame: 1 year

    Any death.

  3. Myocardial infarction

    Time frame: 1 year

    Myocardial infarction was defined and classified as spontaneous or coronary procedure-related MI according to the Fourth Universal Definition of Myocardial Infarction.

  4. Hospitalization due to unstable angina

    Time frame: 1 year

    An hospitalization event in which the final diagnosis was myocardial ischemia.

  5. Exposure to radiation

    Time frame: 1 year

    All exposure to radiation related to CIT and other cardiovascular procedures.

  6. Procedural complications

    Time frame: 1 year

    All procedural complications related to CIT and other cardiovascular procedures.

  7. Cumulative proportion of patients receiving other CITs

    Time frame: 1 year

  8. Cumulative proportion of patients receiving CR

    Time frame: 1 year

  9. Cumulative proportion of patients who had alteration in OMT based on results of CCTA

    Time frame: Thtough the initial management, an average of 2-5 days

  10. Proportion of normal CCTA

    Time frame: Through the initial management, an average of 2-5 days

  11. Proportion of necessary CCTA

    Time frame: Through the initial management, an average of 2-5 days

Other outcomes

  1. The health-related quality of life assessment (SAQ)

    Time frame: 1 year

    Seattle Angina Questionnaire

  2. The health-related quality of life assessment (EQ-5D)

    Time frame: 1 year

    Visual-analogue scale of the European Quality of Life-5 Dimensions

Study contacts

Contact information is provided by the study sponsor or research team.

Jia Zhou, MD

CONTACT

[email protected]

+8615522485560

Sponsors and collaborators

Lead sponsor

Tianjin Chest Hospital

Other

Registry information

Official study title

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

Acronym: OPERATE

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Dec 7, 2022
Registry last updated
Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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