Coronary Heart Disease (CHD)REALISTICNCT06936111
REsiduAL rISk Under Intensive Lipid-lowering Therapy In Coronary Heart Disease
An observational study of Coronary Heart Disease (CHD), run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Intensive lipid-lowering therapy is a cornerstone treatment for coronary heart disease (CHD). However, coronary plaque progression persists in a subset of patients even under intensive lipid-lowering therapy, which may be associated with residual lipid and inflammatory risks. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Heart Disease (CHD)
- What is being tested?
- Assessment of residual cholesterol and inflammatory risk factors
- How many people
- 900 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to Jul 2027
- Phase
- Observational
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will enroll patients with CAD undergoing target lesion PCI, with appropriate non-target lesions near the target lesion, which served as the observed lesions
Who may be able to join
- Diagnosed with CAD and PCI was successfully performed.
- Presence of non-target lesions near the target lesion (more than 5mm proximal or distal), with stenosis of 20% to 50% and identifiable anatomical markers (e.g., branches, calcifications, stent edges).
- 18 to 75 years old.
- Written informed consent.
Who cannot join
- Known autoimmune diseases, or taking immunosuppressive drugs for a long time before onset.
- Known familial hypercholesterolemia.
- Critical conditions (e.g., cardiogenic shock, acute heart failure).
- Severe renal insufficiency (eGFR < 30 mL /(min·1.73m2)), or severe hepatic insufficiency (ALT or AST≥3 times the upper limit of normal).
- Severe underlying diseases (such as end-stage malignancies), life expectancy < 1 year.
- Allergic to lipid-lowering medications.
- Pregnant, or trying to become pregnant, and breastfeeding women.
- Other conditions deemed unsuitable for inclusion by the researcher.
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
Shanghai Zhongshan Hospital
Shanghai
Chunfeng Dai, M.D., 86-021-64041990, dai.chunfeng@zs-hospital.sh.cn
Chunfeng Dai, M.D.
About this study
Official title: Effect of Residual Lipid and Inflammation Risk on Atherosclerotic Plaque Progression Under Intensive Lipid-lowering Therapy in Coronary Heart Disease
Intensive lipid-lowering therapy is a cornerstone treatment for coronary heart disease (CHD). However, coronary plaque progression persists in a subset of patients even under intensive lipid-lowering therapy, which may be associated with residual lipid and inflammatory risks. Current research in this area remains largely confined to post hoc analyses of randomized controlled trials , with a notable scarcity of prospective follow-up cohorts. The investigators propose that establishing a prospective cohort will provide more authentic insights into the associations between residual risk factors and plaque progression. In this project, the investigators aim to establish a well-characterized CHD cohort with comprehensive data collection, good compliance, and an appropriate sample size. By focusing on non-target lesions within the target vessel and utilizing intravascular ultrasound (IVUS), the investigators will investigate the impact of residual lipid and inflammatory risks on plaque progression during intensive lipid-lowering therapy.
- Conditions
- Coronary Heart Disease (CHD)
- Being tested
- Assessment of residual cholesterol and inflammatory risk factors
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of residual cholesterol and inflammatory risk factorsDiagnostic test
The prespecifed risk factors include CRP, SAA, TNF-α, IL-6, MCP-1, Lp-PLA2, PCSK-9, Lp(a)
| Study group | Role | What they receive |
|---|---|---|
| CHD patients undergoing target lesion PCI | This study will enroll patients with CAD undergoing target lesion PCI, with appropriate non-target lesions near the target lesion, which served as the observed lesions Receives: Diagnostic Test: Assessment of residual cholesterol and inflammatory risk factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
coronary plaque progression
percent change in plaque volume measured by IVUS
Measured: 9 to 12 months after PCI
Secondary outcomes (1)
carotid plaque progression
measured by carotid ultrasound
Measured: 9 to 12 months after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start1 Jul 2025
- Primary completionJan 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart Disease (CHD)Studies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunfeng Dai, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936111
- Sponsor's protocol ID
- B2024-377R
- Acronym
- REALISTIC
- Status last verified
- Jan 2026
- First submitted
- 12 Apr 2025
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The research involves some confidential content
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Residual Lipid and Inflammation Risk on Atherosclerotic Plaque Progression Under Intensive Lipid-lowering Therapy in Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT06936111
- Acronym / sponsor ID
- REALISTIC / B2024-377R
- Conditions
- Coronary Heart Disease (CHD)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 20 Apr 2025 (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.
Intensive lipid-lowering therapy is a cornerstone treatment for coronary heart disease (CHD). However, coronary plaque progression persists in a subset of patients even under intensive lipid-lowering therapy, which may be associated with residual lipid and inflammatory risks. Current research in this area remains largely confined to post hoc analyses of randomized controlled trials , with a notable scarcity of prospective follow-up cohorts. The investigators propose that establishing a prospective cohort will provide more authentic insights into the associations between residual risk factors and plaque progression. In this project, the investigators aim to establish a well-characterized CHD cohort with comprehensive data collection, good compliance, and an appropriate sample size. By focusing on non-target lesions within the target vessel and utilizing intravascular ultrasound (IVUS), the investigators will investigate the impact of residual lipid and inflammatory risks on plaque progression during intensive lipid-lowering therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CHD patients undergoing target lesion PCI | – | Diagnostic Test: Assessment of residual cholesterol and inflammatory risk factorsThis study will enroll patients with CAD undergoing target lesion PCI, with appropriate non-target lesions near the target lesion, which served as the observed lesions |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll patients with CAD undergoing target lesion PCI, with appropriate non-target lesions near the target lesion, which served as the observed lesions
Key inclusion criteria (4 listed)
- Diagnosed with CAD and PCI was successfully performed.
- Presence of non-target lesions near the target lesion (more than 5mm proximal or distal), with stenosis of 20% to 50% and identifiable anatomical markers (e.g., branches, calcifications, stent edges).
- 18 to 75 years old.
- Written informed consent.
Key exclusion criteria (8 listed)
- Known autoimmune diseases, or taking immunosuppressive drugs for a long time before onset.
- Known familial hypercholesterolemia.
- Critical conditions (e.g., cardiogenic shock, acute heart failure).
- Severe renal insufficiency (eGFR < 30 mL /(min·1.73m2)), or severe hepatic insufficiency (ALT or AST≥3 times the upper limit of normal).
- Severe underlying diseases (such as end-stage malignancies), life expectancy < 1 year.
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 |
|---|---|---|
| Assessment of residual cholesterol and inflammatory risk factorsThe prespecifed risk factors include CRP, SAA, TNF-α, IL-6, MCP-1, Lp-PLA2, PCSK-9, Lp(a) | Diagnostic test | CHD patients undergoing target lesion PCI |
Primary outcome
coronary plaque progression
Time frame: 9 to 12 months after PCI
percent change in plaque volume measured by IVUS
1 secondary outcome
carotid plaque progression
Time frame: 9 to 12 months after PCI
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 3 Feb 2026.
- Individual participant dataSharing planned: No. The research involves some confidential content
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease (CHD), run by Shanghai Zhongshan Hospital 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 4 inclusion and 8 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 3 Feb 2026. 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. 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 Chunfeng Dai, M.D. (86-021-64041990, dai.chunfeng@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
coronary plaque progression (time frame: 9 to 12 months after PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2026.