InflammationNCT05614050
The Prognosis of Patients After PCI：a Multi-center Study in China
An observational study of Inflammation, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
Coronary artery disease (CAD) is caused by myocardial ischemia, hypoxia or necrosis due to coronary artery stenosis, spasm or obstruction. Although standard drug therapy can greatly improve the prognosis of patients with CAD after percutaneous coronary interventions (PCI), these patients are still at high risk of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Inflammation
- How many people
- 2,400 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 1 Nov 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 80 years
- All sexes
- Adult, Older adult
Study population: The hospitalized patients with coronary heart disease completing all planned PCI
Who may be able to join
- Participants who understand and sign the informed consent voluntarily;
- Age ≥ 18 years old and ≤ 80 years old, regardless of sex;
- The hospitalized patients with coronary heart disease undergoing PCI;
- Complete all planned PCI during hospitalization.
Who cannot join
- Acute, chronic or recurrent infectious diseases;
- Immune diseases or immune-related diseases;
- Long-term use of non-steroidal anti-inflammatory drugs, hormones, immunomodulatory and chemotherapy drugs;
- Pregnant women, lactating women or women of childbearing age who do not use effective contraceptive measures;
- The researchers determined that other conditions in which the patient was not suitable to participate in the clinical trial.
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
Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Xiang Cheng, Doctor, +8602785726011, nathancx@hust.edu.cn
Xiang Cheng, Doctor
About this study
Official title: The Prognosis of Patients After Coronary Intervention (PCI) : a Multi-center Prospective Study in China
Coronary artery disease (CAD) is caused by myocardial ischemia, hypoxia or necrosis due to coronary artery stenosis, spasm or obstruction. Although standard drug therapy can greatly improve the prognosis of patients with CAD after percutaneous coronary interventions (PCI), these patients are still at high risk of major adverse cardiovascular and cerebrovascular events (MACCE). At present, the concept of residual inflammation risk (RIR) has aroused widespread concern. RIR is an important independent risk in patients with CAD. Previous studies indicated that hsCRP ≥ 2mg / L was the definition standard of RIR in CAD in European and American people. In China, the impact of dynamic changes of hsCRP and other inflammatory factors on MACCE in PCI population remains unclear. Therefore, in this study, the investigators plan to recruit patients undergoing PCI, and observe the impact of hsCRP and other inflammatory factors on the prognosis of these patients during long term follow-up at 17 hospitals in China.
- Conditions
- Inflammation
- Medical subject headings
- Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
MACCE
A composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, ischemia-driven revascularization
Measured: 12 months
Secondary outcomes (9)
all-cause death
Occurrence of all-cause death
Measured: 12 months
cardiovascular death
Occurrence of cardiovascular death
Measured: 12 months
nonfatal myocardial infarction
Occurrence of nonfatal myocardial infarction
Measured: 12 months
nonfatal stroke
Occurrence of of nonfatal stroke
Measured: 12 months
ischemia-driven revascularization
Occurrence of ischemia-driven revascularization
Measured: 12 months
hospitalization for unstable angina
Occurrence of hospitalization for unstable angina
Measured: 12 months
stent/scaffold thrombosis
Occurrence of stent/scaffold thrombosis
Measured: 12 months
in-stent restenosis
Occurrence of in-stent restenosis
Measured: 12 months
bleeding
Occurrence of bleeding
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 posted14 Nov 2022
- Study start1 Nov 2022
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- 2,400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Provincial Hospital, The First Affiliated Hospital of Zhengzhou University, The First Affiliated Hospital of Xiamen University, Shanxi Cardiovascular Hospital, First People's Hospital of Xianyang, Yichang Central People's Hospital, Jingzhou Central Hospital, The First Hospital of Wuhan, Wuhan Central Hospital, Wuhan Fourth Hospital, Fifth Hospital in Wuhan, Chinese Academy of Medical Sciences, Fuwai Hospital, Wuhan Asia Heart Hospital, The First Affiliated Hospital of Anhui Medical University, The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture, Hubei University of Medicine
- Responsible party
- Principal investigator, Xiang Cheng, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Xiang Cheng, Doctor, Principal investigator, Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614050
- Sponsor's protocol ID
- ChiPCI
- Status last verified
- Jun 2025
- First submitted
- 6 Nov 2022
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognosis of Patients After Coronary Intervention (PCI) : a Multi-center Prospective Study in China
- ClinicalTrials.gov ID
- NCT05614050
- Acronym / sponsor ID
- ChiPCI
- Conditions
- Inflammation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Shandong Provincial Hospital, The First Affiliated Hospital of Zhengzhou University, The First Affiliated Hospital of Xiamen University, Shanxi Cardiovascular Hospital, First People's Hospital of Xianyang, Yichang Central People's Hospital, Jingzhou Central Hospital, The First Hospital of Wuhan, Wuhan Central Hospital, Wuhan Fourth Hospital, Fifth Hospital in Wuhan, Chinese Academy of Medical Sciences, Fuwai Hospital, Wuhan Asia Heart Hospital, The First Affiliated Hospital of Anhui Medical University, The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture, Hubei University of Medicine
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 14 Nov 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.
Coronary artery disease (CAD) is caused by myocardial ischemia, hypoxia or necrosis due to coronary artery stenosis, spasm or obstruction. Although standard drug therapy can greatly improve the prognosis of patients with CAD after percutaneous coronary interventions (PCI), these patients are still at high risk of major adverse cardiovascular and cerebrovascular events (MACCE). At present, the concept of residual inflammation risk (RIR) has aroused widespread concern. RIR is an important independent risk in patients with CAD. Previous studies indicated that hsCRP ≥ 2mg / L was the definition standard of RIR in CAD in European and American people. In China, the impact of dynamic changes of hsCRP and other inflammatory factors on MACCE in PCI population remains unclear. Therefore, in this study, the investigators plan to recruit patients undergoing PCI, and observe the impact of hsCRP and other inflammatory factors on the prognosis of these patients during long term follow-up at 17 hospitals in China.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The hospitalized patients with coronary heart disease completing all planned PCI
Key inclusion criteria (4 listed)
- Participants who understand and sign the informed consent voluntarily;
- Age ≥ 18 years old and ≤ 80 years old, regardless of sex;
- The hospitalized patients with coronary heart disease undergoing PCI;
- Complete all planned PCI during hospitalization.
Key exclusion criteria (5 listed)
- Acute, chronic or recurrent infectious diseases;
- Immune diseases or immune-related diseases;
- Long-term use of non-steroidal anti-inflammatory drugs, hormones, immunomodulatory and chemotherapy drugs;
- Pregnant women, lactating women or women of childbearing age who do not use effective contraceptive measures;
- The researchers determined that other conditions in which the patient was not suitable to participate in the clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MACCE
Time frame: 12 months
A composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, ischemia-driven revascularization
9 secondary outcomes
all-cause death
Time frame: 12 months
cardiovascular death
Time frame: 12 months
nonfatal myocardial infarction
Time frame: 12 months
nonfatal stroke
Time frame: 12 months
ischemia-driven revascularization
Time frame: 12 months
hospitalization for unstable angina
Time frame: 12 months
stent/scaffold thrombosis
Time frame: 12 months
in-stent restenosis
Time frame: 12 months
bleeding
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 Jun 2025.
- 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.
Xiang Cheng, Doctor principal investigator
Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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 Inflammation, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 5 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 Jun 2025. 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 Miao Yu (+862785726009, yumiaodavid@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACCE (time frame: 12 months). 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 26 Jun 2025.