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The Prognosis of Patients After PCI:a Multi-center Study in China

The Prognosis of Patients After Coronary Intervention (PCI) : a Multi-center Prospective Study in China

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05614050
Enrollment
2400
Registered
2022-11-14
Start date
2022-11-01
Completion date
2027-11-01
Last updated
2025-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation

Brief 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 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.

Interventions

None listed

Sponsors

Shandong Provincial Hospital
CollaboratorOTHER_GOV
The First Affiliated Hospital of Zhengzhou University
CollaboratorOTHER
The First Affiliated Hospital of Xiamen University
CollaboratorOTHER
Shanxi Cardiovascular Hospital
CollaboratorOTHER
First People's Hospital of Xianyang
CollaboratorOTHER
Yichang Central People's Hospital
CollaboratorOTHER
Jingzhou Central Hospital
CollaboratorOTHER
The First Hospital of Wuhan
CollaboratorUNKNOWN
Wuhan Central Hospital
CollaboratorOTHER
Wuhan Fourth Hospital
CollaboratorUNKNOWN
Fifth Hospital in Wuhan
CollaboratorUNKNOWN
Chinese Academy of Medical Sciences, Fuwai Hospital
CollaboratorOTHER
Wuhan Asia Heart Hospital
CollaboratorOTHER
The First Affiliated Hospital of Anhui Medical University
CollaboratorOTHER
Central Hospital of Enshi Tujia and Miao Autonomous Prefecture
CollaboratorUNKNOWN
Hubei University of Medicine
CollaboratorOTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
MACCE12 monthsA composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, ischemia-driven revascularization

Secondary

MeasureTime frameDescription
cardiovascular death12 monthsOccurrence of cardiovascular death
nonfatal myocardial infarction12 monthsOccurrence of nonfatal myocardial infarction
nonfatal stroke12 monthsOccurrence of of nonfatal stroke
ischemia-driven revascularization12 monthsOccurrence of ischemia-driven revascularization
all-cause death12 monthsOccurrence of all-cause death
stent/scaffold thrombosis12 monthsOccurrence of stent/scaffold thrombosis
in-stent restenosis12 monthsOccurrence of in-stent restenosis
bleeding12 monthsOccurrence of bleeding
hospitalization for unstable angina12 monthsOccurrence of hospitalization for unstable angina

Countries

China

Contacts

Primary ContactMiao Yu
yumiaodavid@126.com+862785726009

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026