StatinRESPECT2NCT05725096
Role of Coronary CTA on Lipid Management and Risk Factors Control in an Asymptomatic Chinese Population
A study testing Coronary Computed Tomography Angiography and Traditional cardiovascular risk stratification in people with Statin and Cardiovascular Risk Factors, run by Zhang longjiang,MD at 1 site in China.
Trial summary
The primary objective of this study is to determine whether coronary computed tomography angiography (CCTA) -based coronary heart disease(CHD) prevention strategy improves lipid-lowering treatment and cardiovascular risk factor control compared with traditional CHD prevention strategy, guided by a cardiovascular risk… Read more about this study
- Who is it for?
- Ages 40 to 69 years
- Conditions the study is for
- Statin, Cardiovascular Risk Factors, Primary Prevention
- What is being tested?
- Coronary Computed Tomography Angiography and Traditional cardiovascular risk stratification
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,400 participants
- Where
- 1 siteChina
- Study dates
- 28 Jun 2023to Jun 2027
- 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 40 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Nanjing residents who have no plans to leave in the next 5 years
- Aged from 40 to 69 years
- Free of any known clinically cardiovascular disease Able to comprehend and sign an informed consent form
Who cannot join
- Serious liver dysfunction, defined as AST or ALT > 3 times the normal upper limit
- Chronic kidney disease (CKD) > stage 4, defined as eGFR < 30 ml/min/1.73 m2
- Prior CCTA or invasive coronary angiography within the last 5 years
- Any contraindications for CCTA
- Previous use of statin or non-statin lipid-lowering medication (such as ezetimibe, PCSK9 inhibitor and XueZhiKang)
- Life expectancy < 3 years
- Other reasons the researcher deems inappropriate to attend
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Research Institute Of Medical Imaging Jinling Hospital
Nanjing, Jiangsu, 210018
longjiang Zhang, MD, 13405833176, kevinzhlj@163.com
Xiang Guo, MD, 15820077389, sdtzgx@163.com
About this study
Official title: Role of the Screening with Coronary Computed Tomography Angiography on Lipid Management and Risk Factors Control in an Asymptomatic Chinese Population: a Community-based, Prospective Randomised Trial
The primary objective of this study is to determine whether coronary computed tomography angiography (CCTA) -based coronary heart disease(CHD) prevention strategy improves lipid-lowering treatment and cardiovascular risk factor control compared with traditional CHD prevention strategy, guided by a cardiovascular risk score.
Read the detailed description
At present, doctors usually use a "risk score" to identify people at risk of heart disease who may benefit from medical treatment. In the RESPECT study the investigator will compare this "risk score" to coronary CTA scan. In this study the investigator would like to determine the effect of coronary CTA scan on lipid-lowering treatment and cardiovascular risk factor control.
This study will recruit 3400 eligible community volunteers (asymptomatic individuals free of any known cardiovascular event) aged 40 to 69 years, then, randomized (1:1) them to receive individualized primary prevention programs for coronary heart disease based on CCTA results or traditional risk score, as recommended in the Chinese CVD prevention guidelines. The intervention strategies in this study are consistent with RESPECT trial.
The investigator will assess the difference of lipid-lowering treatment and cardiovascular risk factor control between two groups 12 months later. Furthermore, the investigator will present the results of subclinical coronary atherosclerosis in participants who have undergone coronary CTA scans. This will help us understand the prevalence of subclinical coronary atherosclerotic disease in an asymptomatic Chinese population.
- Being tested
- Coronary Computed Tomography Angiography, Traditional cardiovascular risk stratification
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Computed Tomography AngiographyDiagnostic test
Intervention strategies according to CCTA results
Traditional cardiovascular risk stratificationOther
Intervention strategies according to traditional cardiovascular risk stratification based on Chinese guidelines for lipid management (2023)
| Study group | Role | What they receive |
|---|---|---|
| CCTA-based strategy group | Active comparator | Subjects will be managed following the CCTA -based coronary heart disease prevention strategy for lipid-lowering treatment and follow-up. Receives: Diagnostic Test: Coronary Computed Tomography Angiography |
| Chinese guidelines for lipid management (2023) | Sham comparator | The baseline assessment will be completed on the same day as consent is gained. Every subjects will complete a comprehensive assessment including questionnaires and objective assessments. Receives: Other: Traditional cardiovascular risk stratification |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants taking lipid-lowering medication regularly at both 6 and 12 months
Taking lipid-lowering medication regularly defined as taking the established lipid-lowering medication (including statin, ezetimibe, xuezhikang and PCSK9 inhibitor) at least 24 days during the past 30 days.
Measured: 12 months
Secondary outcomes (10)
The proportion of participants achieving LDL-C targets at 12 months
The LDL-C treatment goals are made according to Chinese guideline
Measured: 12 months
The proportion of participants taking lipid-lowering medication regularly at 12 months.
The proportion of participants taking lipid-lowering medication regularly at 12 months. Taking lipid-lowering medication regularly defined as taking the established lipid-lowering medication (including statin, ezetimibe, xuezhikang and PCSK9 inhibitor) at least 24 days during the past 30 days.
Measured: 12 months
Cardiovascular events
Number of participants diagnosed with coronary heart disease, stroke (hemorrhagic and ischemic), TIA or cardiovascular death
Measured: 12 months
Prevalence of subclinical coronary atherosclerotic disease
Proportion of subjects with coronary atherosclerosis in participants who underwent coronary CTA scan (%)
Measured: baseline
LDL-C levels
Compare the difference in LDL-C concentration between baseline and one year later, with the measurement unit being mmol/L.
Measured: 12 months
Hypertension control
SBP<140mmHg and DBP<90mmHg
Measured: 12 months
Diabetic control
HbA1c <53 mmol/mol (7.0%)
Measured: 12 months
Smoking cessation
Proportion of subjects who changed smoking habits (%)
Measured: 12 months
Exercise
Change in activity levels measured through international physical activity questionnaire
Measured: 12 months
Quality of life/Anxiety and Depression
Change in quality of life measured through PHQ-9 (patient health questionnaire): anxiety and depression score (%)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start28 Jun 2023
- Primary completionMar 2025 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StatinStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhang longjiang,MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhang longjiang,MD, Jinling Hospital, China
- Investigators
- Trail Manager, Study chair, Jinling Hospital,Nanjing University School of Medicine,Nanjing,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725096
- Sponsor's protocol ID
- 2022DZKY-056-01
- Acronym
- RESPECT2
- Status last verified
- Nov 2024
- First submitted
- 2 Feb 2023
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guo X, Zhu Y, Li Y, Qiu S, Yang J, Li C, Zhu Y, Zhong J, Zhang J, Zhou C, Bao X, Yi D, Cai J, Chen Y, Li J, Wei Y, Liu Y, Cheng X, Tang C, Zhang LJ. Coronary computed tomography angiography to guide lipid management in an asymptomatic community-based population: RESPECT2 randomized controlled trial. Eur J Prev Cardiol. 2026 Aug 28:zwag418. doi: 10.1093/eurjpc/zwag418. Online ahead of print.
PubMed 42661433Guo X, Li J, Zhu Y, Li Y, Jiang J, Zuo R, Xu W, Ma J, Li C, Yang J, Liu Y, Zhao M, Tian D, Wang X, Sun J, Wu B, Wang C, Jiang P, Zhang J, Zhong J, Zhou C, Yi D, Bao X, Cai J, Chen Y, Cheng X, Gong H, Wei Y, Liu Y, Zhang LJ. Role of the screening with coronary computed tomography angiography on lipid management and risk factors control in an asymptomatic Chinese population: a community-based, parallel-group, open-label, randomized clinical trial (RESPECT2). Trials. 2024 Sep 30;25(1):635. doi: 10.1186/s13063-024-08469-z.
PubMed 39350195
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Screening with Coronary Computed Tomography Angiography on Lipid Management and Risk Factors Control in an Asymptomatic Chinese Population: a Community-based, Prospective Randomised Trial
- ClinicalTrials.gov ID
- NCT05725096
- Acronym / sponsor ID
- RESPECT2 / 2022DZKY-056-01
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,400 participants (estimated)
- Lead sponsor
- Zhang longjiang,MDUniversity, hospital or other
- Study start
- 28 Jun 2023 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 13 Feb 2023 (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.
The primary objective of this study is to determine whether coronary computed tomography angiography (CCTA) -based coronary heart disease(CHD) prevention strategy improves lipid-lowering treatment and cardiovascular risk factor control compared with traditional CHD prevention strategy, guided by a cardiovascular risk score.
Detailed description
At present, doctors usually use a "risk score" to identify people at risk of heart disease who may benefit from medical treatment. In the RESPECT study the investigator will compare this "risk score" to coronary CTA scan. In this study the investigator would like to determine the effect of coronary CTA scan on lipid-lowering treatment and cardiovascular risk factor control.
This study will recruit 3400 eligible community volunteers (asymptomatic individuals free of any known cardiovascular event) aged 40 to 69 years, then, randomized (1:1) them to receive individualized primary prevention programs for coronary heart disease based on CCTA results or traditional risk score, as recommended in the Chinese CVD prevention guidelines. The intervention strategies in this study are consistent with RESPECT trial.
The investigator will assess the difference of lipid-lowering treatment and cardiovascular risk factor control between two groups 12 months later. Furthermore, the investigator will present the results of subclinical coronary atherosclerosis in participants who have undergone coronary CTA scans. This will help us understand the prevalence of subclinical coronary atherosclerotic disease in an asymptomatic Chinese population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CCTA-based strategy group | Active comparator | Diagnostic Test: Coronary Computed Tomography AngiographySubjects will be managed following the CCTA -based coronary heart disease prevention strategy for lipid-lowering treatment and follow-up. |
| Chinese guidelines for lipid management (2023) | Sham comparator | Other: Traditional cardiovascular risk stratificationThe baseline assessment will be completed on the same day as consent is gained. Every subjects will complete a comprehensive assessment including questionnaires and objective assessments. |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Nanjing residents who have no plans to leave in the next 5 years
- Aged from 40 to 69 years
- Free of any known clinically cardiovascular disease Able to comprehend and sign an informed consent form
Key exclusion criteria (7 listed)
- Serious liver dysfunction, defined as AST or ALT > 3 times the normal upper limit
- Chronic kidney disease (CKD) > stage 4, defined as eGFR < 30 ml/min/1.73 m2
- Prior CCTA or invasive coronary angiography within the last 5 years
- Any contraindications for CCTA
- Previous use of statin or non-statin lipid-lowering medication (such as ezetimibe, PCSK9 inhibitor and XueZhiKang)
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 |
|---|---|---|
| Coronary Computed Tomography AngiographyIntervention strategies according to CCTA results | Diagnostic test | CCTA-based strategy group |
| Traditional cardiovascular risk stratificationIntervention strategies according to traditional cardiovascular risk stratification based on Chinese guidelines for lipid management (2023) | Other | Chinese guidelines for lipid management (2023) |
Primary outcome
The proportion of participants taking lipid-lowering medication regularly at both 6 and 12 months
Time frame: 12 months
Taking lipid-lowering medication regularly defined as taking the established lipid-lowering medication (including statin, ezetimibe, xuezhikang and PCSK9 inhibitor) at least 24 days during the past 30 days.
10 secondary outcomes
The proportion of participants achieving LDL-C targets at 12 months
Time frame: 12 months
The proportion of participants taking lipid-lowering medication regularly at 12 months.
Time frame: 12 months
Cardiovascular events
Time frame: 12 months
Prevalence of subclinical coronary atherosclerotic disease
Time frame: baseline
LDL-C levels
Time frame: 12 months
Hypertension control
Time frame: 12 months
Diabetic control
Time frame: 12 months
Smoking cessation
Time frame: 12 months
Exercise
Time frame: 12 months
Quality of life/Anxiety and Depression
Time frame: 12 months
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 26 Nov 2024.
- Derived from this study: PubMed 42661433Guo X, Zhu Y, Li Y, Qiu S, Yang J, Li C, Zhu Y, Zhong J, Zhang J, Zhou C, Bao X, Yi D, Cai J, Chen Y, Li J, Wei Y, Liu Y, Cheng X, Tang C, Zhang LJ. Coronary computed tomography angiography to guide lipid management in an asymptomatic community-based population: RESPECT2 randomized controlled trial. Eur J Prev Cardiol. 2026 Aug 28:zwag418. doi: 10.1093/eurjpc/zwag418. Online ahead of print.
- Derived from this study: PubMed 39350195Guo X, Li J, Zhu Y, Li Y, Jiang J, Zuo R, Xu W, Ma J, Li C, Yang J, Liu Y, Zhao M, Tian D, Wang X, Sun J, Wu B, Wang C, Jiang P, Zhang J, Zhong J, Zhou C, Yi D, Bao X, Cai J, Chen Y, Cheng X, Gong H, Wei Y, Liu Y, Zhang LJ. Role of the screening with coronary computed tomography angiography on lipid management and risk factors control in an asymptomatic Chinese population: a community-based, parallel-group, open-label, randomized clinical trial (RESPECT2). Trials. 2024 Sep 30;25(1):635. doi: 10.1186/s13063-024-08469-z.
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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.
Trail Manager study chair
Jinling Hospital,Nanjing University School of Medicine,Nanjing,China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary Computed Tomography Angiography and Traditional cardiovascular risk stratification in people with Statin and Cardiovascular Risk Factors, run by Zhang longjiang,MD at 1 site 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 3 inclusion and 7 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 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 Longjiang Zhang, MD (13405833167, kevinzhlj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of participants taking lipid-lowering medication regularly at both 6 and 12 months (time frame: 12 months). 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 NCT05725096, which also lists 2 linked publications.
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 26 Nov 2024.