Optimal Evaluation to Reduce Cardiovascular Imaging Testing

NCT ID: NCT05640752

Last Updated: 2024-12-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-11
• Study Completion Date: 2025-12-11

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.

Conditions

Chronic Coronary Syndrome

Keywords

Stable Chest Pain; Pretest Probability; Coronary Computed Tomography Angiography; Diagnostic Strategy; Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

ESC 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 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.

Group Type: EXPERIMENTAL

2019 ESC guideline-determined diagnostic strategy

Intervention Type: 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.

NICE strategy

According to NICE strategy, subjects with nonanginal chest pain and normal ECG are classified into low risk group and ones with typical and atypical angina or nonanginal chest pain with abnormal ECG are classified into high 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.

Group Type: EXPERIMENTAL

2016 NICE guideline-determined diagnostic strategy

Intervention Type: 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.

Interventions

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 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.

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Chest Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhou Jia

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jia Zhou, MD

Role: PRINCIPAL_INVESTIGATOR

Tianjin Chest Hospital

Locations

Beijing Chaoyang Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Hebei Petrochina Central Hospital

Lanfang, Hebei, China

Site Status: RECRUITING

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Tianjin Chest Hospital

Tianjin, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Jia Zhou, MD

Role: CONTACT

Phone: +8615522485560

Email: zhoujiawenzhang@126.com

Facility Contacts

Yahang Tan

Role: primary

Tao Cheng

Role: primary

Ting Xin

Role: primary

Jia Zhou

Role: primary

References

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/s12872-023-03424-3.

Reference Type: DERIVED

PMID: 37612631 (View on PubMed)

Other Identifiers

62206197

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

TJWJ2022QN067

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

21JCYBJC00820

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2022KY-024-01

Identifier Type: -

Identifier Source: org_study_id