Coronary Artery DiseaseIMPACT-PCINCT07117084
Imaging Markers of High-Risk Plaque Phenotype for Predicting Post-PCI Outcomes
An observational study of Coronary Artery Disease and Percutaneous Coronary Intervention (PCI), run by Chinese Academy of Medical Sciences, Fuwai Hospital at 3 sites in China.
Trial summary
Despite the widespread use of stents, previous studies have shown that stent implantation mainly relieves symptoms but may not significantly improve long-term outcomes in patients with stable coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Percutaneous Coronary Intervention (PCI), Atherosclerosis of Coronary Artery
- What is being tested?
- CCTA-derived Plaque Quantification
- How many people
- 2,000 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jan 2021to Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent clinically indicated PCI within 30 days after coronary CT angiography.
Who may be able to join
- patients aged 18 years or older;
- patients who underwent clinically indicated PCI within 30 days following CCTA;
- CCTA demonstrating the presence of coronary atherosclerotic plaque.
Who cannot join
- patients whose PCI within 30 days after CCTA was performed on an emergency basis;
- elevated cardiac troponin levels within the 3 months preceding PCI;
- inadequate CCTA image quality;
- balloon-only or mixed stent/balloon PCI strategies;
- PCI for non-atherosclerotic lesions (e.g., in-stent restenosis, spontaneous coronary dissection);
- history of coronary artery bypass grafting;
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- heart failure;
- non-ischemic cardiomyopathy;
- significant valvular heart disease;
- refractory hypertension;
- persistent atrial fibrillation.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100037
Tai'an Central Hospital
Tai’an, Shandong, 271000
Weifang People's Hospital
Weifang, Shandong, 261000
About this study
Official title: Imaging Markers of High-Risk Plaque Phenotype for Predicting Post-PCI Outcomes (IMPACT-PCI) Study: A Multicenter Cohort Study Based on Coronary CT Angiography
Despite the widespread use of stents, previous studies have shown that stent implantation mainly relieves symptoms but may not significantly improve long-term outcomes in patients with stable coronary artery disease. Identifying the types of plaques that are most likely to benefit from stenting is essential for improving personalized treatment. This study explores whether coronary computed tomography angiography (CCTA)-derived imaging biomarkers of coronary plaques are associated with increased risk of adverse outcomes after percutaneous coronary intervention (PCI). Around 2,000 patients who underwent CCTA followed by stent placement were included. Advanced software was used to quantify plaque inflammation and composition. Findings from this research may help guide personalized treatment strategies in patients undergoing PCI.
- Conditions
- Coronary Artery Disease, Percutaneous Coronary Intervention (PCI), Atherosclerosis of Coronary Artery
- Being tested
- CCTA-derived Plaque Quantification
- 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.
CCTA-derived Plaque QuantificationDiagnostic test
Quantitative analysis of coronary plaque features based on coronary CT angiography using semi-automated software.
| Study group | Role | What they receive |
|---|---|---|
| CCTA-PCI Cohort | Patients who underwent coronary CT angiography followed by PCI within 30 days. Receives: Diagnostic Test: CCTA-derived Plaque Quantification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events (MACE)
Composite of cardiovascular death, non-fatal myocardial infarction, repeat revascularization, and hospitalization for unstable angina.
Measured: From the date of PCI until December 2024 (minimum 2-year follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start1 Jan 2021
- Primary completion31 Dec 2024
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai 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
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bin Lu, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Bin Lu, MD, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117084
- Sponsor's protocol ID
- IMPACT-PCI study
- Other IDs
- 2024-2586
- Acronym
- IMPACT-PCI
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional data privacy policies and lack of data-sharing agreements.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Markers of High-Risk Plaque Phenotype for Predicting Post-PCI Outcomes (IMPACT-PCI) Study: A Multicenter Cohort Study Based on Coronary CT Angiography
- ClinicalTrials.gov ID
- NCT07117084
- Acronym / sponsor ID
- IMPACT-PCI / IMPACT-PCI study
- Conditions
- Coronary Artery Disease, Percutaneous Coronary Intervention (PCI), Atherosclerosis of Coronary Artery
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 12 Aug 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.
Despite the widespread use of stents, previous studies have shown that stent implantation mainly relieves symptoms but may not significantly improve long-term outcomes in patients with stable coronary artery disease. Identifying the types of plaques that are most likely to benefit from stenting is essential for improving personalized treatment. This study explores whether coronary computed tomography angiography (CCTA)-derived imaging biomarkers of coronary plaques are associated with increased risk of adverse outcomes after percutaneous coronary intervention (PCI). Around 2,000 patients who underwent CCTA followed by stent placement were included. Advanced software was used to quantify plaque inflammation and composition. Findings from this research may help guide personalized treatment strategies in patients undergoing PCI.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CCTA-PCI Cohort | – | Diagnostic Test: CCTA-derived Plaque QuantificationPatients who underwent coronary CT angiography followed by PCI within 30 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent clinically indicated PCI within 30 days after coronary CT angiography.
Key inclusion criteria (3 listed)
- patients aged 18 years or older;
- patients who underwent clinically indicated PCI within 30 days following CCTA;
- CCTA demonstrating the presence of coronary atherosclerotic plaque.
Key exclusion criteria (11 listed)
- patients whose PCI within 30 days after CCTA was performed on an emergency basis;
- elevated cardiac troponin levels within the 3 months preceding PCI;
- inadequate CCTA image quality;
- balloon-only or mixed stent/balloon PCI strategies;
- PCI for non-atherosclerotic lesions (e.g., in-stent restenosis, spontaneous coronary dissection);
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 |
|---|---|---|
| CCTA-derived Plaque QuantificationQuantitative analysis of coronary plaque features based on coronary CT angiography using semi-automated software. | Diagnostic test | CCTA-PCI Cohort |
Primary outcome
Major adverse cardiovascular events (MACE)
Time frame: From the date of PCI until December 2024 (minimum 2-year follow-up)
Composite of cardiovascular death, non-fatal myocardial infarction, repeat revascularization, and hospitalization for unstable angina.
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 12 Aug 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional data privacy policies and lack of data-sharing agreements.
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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. This study is not recruiting at the moment.
Bin Lu, MD principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Percutaneous Coronary Intervention (PCI), run by Chinese Academy of Medical Sciences, Fuwai Hospital at 3 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 3 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: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular events (MACE) (time frame: From the date of PCI until December 2024 (minimum 2-year follow-up)). 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 12 Aug 2025.