Optimal Evaluation to Reduce Cardiovascular Imaging Testing

NCT05640752 | Recruiting DMC

• 4 other identifiers: 2022KY-024-0162206197TJWJ2022QN06721JCYBJC00820
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 4

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).

Conditions

Chronic Coronary Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• CCTA without obstructive CAD

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

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

Secondary Outcomes (11)

• MACE

  1 year

• All-cause death

  1 year

• Myocardial infarction

  1 year

• Hospitalization due to unstable angina

  1 year

• Exposure to radiation

  1 year

Other Outcomes (2)

• The health-related quality of life assessment (SAQ)

  1 year

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

  1 year

Study Arms (2)

ESC strategy

EXPERIMENTAL

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.

Diagnostic Test: 2019 ESC guideline-determined diagnostic strategy

NICE strategy

EXPERIMENTAL

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.

Diagnostic Test: 2016 NICE guideline-determined diagnostic strategy

Interventions

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.

ESC strategy

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.

NICE strategy

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin Chest Hospital: lead

Study Sites (4)

Beijing Chaoyang Hospital

Beijing, Beijing Municipality, China

RECRUITING

Hebei Petrochina Central Hospital

Lanfang, Hebei, China

RECRUITING

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

Tianjin Chest Hospital

Tianjin, 300000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 37612631 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Jia Zhou, MD

  Tianjin Chest Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jia Zhou, MD

CONTACT

+8615522485560; zhoujiawenzhang@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 27, 2022
• First Posted: December 7, 2022
• Study Start: December 11, 2023
• Primary Completion: December 11, 2024
• Study Completion: December 11, 2025
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)