Chronic Coronary SyndromeOPERATENCT05640752
Optimal Evaluation to Reduce Cardiovascular Imaging Testing
A study testing 2019 ESC guideline-determined diagnostic strategy and 2016 NICE guideline-determined diagnostic strategy in people with Chronic Coronary Syndrome, run by Tianjin Chest Hospital at 4 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Chronic Coronary Syndrome
- What is being tested?
- 2019 ESC guideline-determined diagnostic strategy and 2016 NICE guideline-determined diagnostic strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 4 sitesChina
- Study dates
- 11 Dec 2023to 11 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Beijing Chaoyang Hospital
Beijing, Beijing Municipality
Yahang Tan
- Recruiting
Hebei Petrochina Central Hospital
Lanfang, Hebei
Tao Cheng
- Recruiting
Tianjin First Central Hospital
Tianjin, Tianjin Municipality
Ting Xin
- Recruiting
Tianjin Chest Hospital
Tianjin, 300000
Jia Zhou, +15522485560, zhoujiawenzhang@126.com
About this study
Official title: Optimal Evaluation of Stable Chest Pain to Reduce Unnecessary Utilization of Cardiac 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).
Read the 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
- Being tested
- 2019 ESC guideline-determined diagnostic strategy, 2016 NICE guideline-determined diagnostic strategy
- Keywords
- Stable Chest Pain, Pretest Probability, Coronary Computed Tomography Angiography, Diagnostic Strategy, Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2019 ESC guideline-determined diagnostic strategyDiagnostic 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 strategyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: 2016 NICE guideline-determined diagnostic strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
CCTA without obstructive CAD
The summary of nonobstructive CAD, no sign of CAD and nondiagnostic result detected by CCTA according to each strategy
Measured: Through the initial management, an average of 2-5 days
Secondary outcomes (11)
MACE
All-cause death, myocardial infarction and hospitalization due to unstable angina.
Measured: 1 year
All-cause death
Any death.
Measured: 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.
Measured: 1 year
Hospitalization due to unstable angina
An hospitalization event in which the final diagnosis was myocardial ischemia.
Measured: 1 year
Exposure to radiation
All exposure to radiation related to CIT and other cardiovascular procedures.
Measured: 1 year
Procedural complications
All procedural complications related to CIT and other cardiovascular procedures.
Measured: 1 year
Cumulative proportion of patients receiving other CITs
Measured: 1 year
Cumulative proportion of patients receiving CR
Measured: 1 year
Cumulative proportion of patients who had alteration in OMT based on results of CCTA
Measured: Thtough the initial management, an average of 2-5 days
Proportion of normal CCTA
Measured: Through the initial management, an average of 2-5 days
Proportion of necessary CCTA
Measured: Through the initial management, an average of 2-5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start11 Dec 2023
- Primary completion11 Dec 2024
- Study completion11 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Jia, Tianjin Chest Hospital
- Investigators
- Jia Zhou, MD, Principal investigator, Tianjin Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05640752
- Sponsor's protocol ID
- 2022KY-024-01
- Other IDs
- 62206197, TJWJ2022QN067, 21JCYBJC00820
- Acronym
- OPERATE
- Status last verified
- Dec 2024
- First submitted
- 27 Nov 2022
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37612631
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Evaluation of Stable Chest Pain to Reduce Unnecessary Utilization of Cardiac Imaging Testing
- ClinicalTrials.gov ID
- NCT05640752
- Acronym / sponsor ID
- OPERATE / 2022KY-024-01
- Conditions
- Chronic Coronary Syndrome
- Keywords
- Stable Chest Pain, Pretest Probability, Coronary Computed Tomography Angiography, Diagnostic Strategy, Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Tianjin Chest HospitalUniversity, hospital or other
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 11 Dec 2024 (actual)
- Study completion
- 11 Dec 2025 (estimated)
- First posted
- 7 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESC strategy | Experimental | Diagnostic Test: 2019 ESC guideline-determined diagnostic strategyESC-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 | Experimental | Diagnostic Test: 2016 NICE guideline-determined diagnostic strategyAccording 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. |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2019 ESC guideline-determined diagnostic strategyESC-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 | ESC strategy |
| 2016 NICE guideline-determined diagnostic strategyFor 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. | Diagnostic test | NICE strategy |
Primary outcome
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
11 secondary outcomes
MACE
Time frame: 1 year
All-cause death
Time frame: 1 year
Myocardial infarction
Time frame: 1 year
Hospitalization due to unstable angina
Time frame: 1 year
Exposure to radiation
Time frame: 1 year
Procedural complications
Time frame: 1 year
Cumulative proportion of patients receiving other CITs
Time frame: 1 year
Cumulative proportion of patients receiving CR
Time frame: 1 year
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
Proportion of normal CCTA
Time frame: Through the initial management, an average of 2-5 days
Proportion of necessary CCTA
Time frame: Through the initial management, an average of 2-5 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Derived from this study: PubMed 37612631Zhou 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jia Zhou, MD principal investigator
Tianjin Chest Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2019 ESC guideline-determined diagnostic strategy and 2016 NICE guideline-determined diagnostic strategy in people with Chronic Coronary Syndrome, run by Tianjin Chest Hospital at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jia Zhou, MD (+8615522485560, zhoujiawenzhang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CCTA without obstructive CAD (time frame: Through the initial management, an average of 2-5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05640752, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.