Optimal Evaluation to Reduce Cardiovascular Imaging Testing

ConditionChronic Coronary Syndrome

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age30-90

SponsorTianjin Chest Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

800 Participants

are divided into 2 treatment groups

Group A: ESC strategyExperimental treatment 1 intervention

Group B: NICE strategyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

CCTA without obstructive CAD

The summary of nonobstructive CAD, no sign of CAD and nondiagnostic result detected by CCTA according to each strategy

Time frame

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

Secondary outcomes

MACE

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

Time frame

1 year

All-cause death

Any death.

Time frame

1 year

Myocardial infarction

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

Time frame

1 year

Hospitalization due to unstable angina

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

Time frame

1 year

Other outcomes

The health-related quality of life assessment (SAQ)

Seattle Angina Questionnaire

Time frame

1 year

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

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

Time frame

1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tianjin Chest Hospital

Lead sponsor

Source ClinicalTrials.gov

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