Actively Recruiting

Phase Not Applicable
Age: 30Years - 90Years
All Genders
ID05640752

Optimal Evaluation of Stable Chest Pain to Reduce Unnecessary Cardiac Imaging Comparing 2016 NICE and 2019 ESC Diagnostic Strategies for Chronic Coronary Syndrome

Led by Tianjin Chest Hospital · Updated on 2024-12-24

800

Participants Needed

4

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating two diagnostic strategies to manage new or stable chest pain that may indicate chronic coronary syndrome (CCS). This trial aims to identify patients at low risk who might not benefit from further cardiac imaging tests, specifically coronary computed tomography angiography (CCTA). The OPERATE study is a pragmatic randomized controlled trial designed to compare the effectiveness and safety of these strategies in routine clinical practice, addressing the challenge of reducing unnecessary imaging. The study randomly assigns about 800 participants with stable chest pain suggestive of CCS into two groups. One group follows the 2016 NICE guideline strategy, which classifies patients by chest pain type and ECG results to decide if CCTA is needed. The other group follows the 2019 ESC guideline strategy, which uses calculated risk scores based on age, sex, chest pain type, and cardiovascular risk factors to determine who should undergo CCTA. Patients considered low risk under either strategy receive optimal medical treatment without immediate imaging. Participants will be monitored through their initial management period, averaging 2 to 5 days, to determine the rate of CCTA without obstructive coronary artery disease. The trial also assesses major adverse cardiac events over a one-year follow-up to ensure safety. Throughout the study, data on imaging results, clinical events, and treatment adherence will be collected to compare the diagnostic strategies' impact on patient care and resource use.

CONDITIONS

Official Title

Optimal Evaluation to Reduce Cardiovascular Imaging Testing

Who Can Participate

Age: 30Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Stable or new-onset chest pain suggestive of chronic coronary syndrome and clinically stable
  • No history of coronary artery disease, including prior myocardial infarction, coronary revascularization, or documented CAD by previous cardiac imaging
  • Age 30 years or older
  • Willing and able to provide informed consent
Not Eligible

You will not qualify if you...

  • Cardiac imaging test within the past year before randomization
  • Clinical instability such as cardiogenic shock, acute coronary syndrome, severe arrhythmias, or NYHA class III or IV heart failure
  • Non-sinus heart rhythm
  • Participation in another clinical trial
  • Complex structural heart disease
  • Non-cardiac illness with life expectancy less than 2 years
  • Allergy to iodinated contrast agents
  • Estimated glomerular filtration rate below 60 ml/min/1.73m2 within 90 days
  • Body mass index over 35 kg/m2
  • Clear preference for or against undergoing cardiac imaging testing
  • Pregnancy

AI-Screening

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Trial Site Locations

Total: 4 locations

1

Beijing Chaoyang Hospital

Beijing, Beijing Municipality, China

Actively Recruiting

2

Hebei Petrochina Central Hospital

Lanfang, Hebei, China

Actively Recruiting

3

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, China

Actively Recruiting

4

Tianjin Chest Hospital

Tianjin, China, 300000

Actively Recruiting

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Research Team

J

Jia Zhou, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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Published Research Related To This Trial

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.

Jia Zhou, Ting Xin, Yahang Tan...

https://pubmed.ncbi.nlm.nih.gov/37612631