NCT05614050

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,400

participants targeted

Target at P75+ for all trials

Timeline
18mo left

Started Nov 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Nov 2022Nov 2027

Study Start

First participant enrolled

November 1, 2022

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 14, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

June 26, 2025

Status Verified

June 1, 2025

Enrollment Period

5 years

First QC Date

November 6, 2022

Last Update Submit

June 22, 2025

Conditions

Inflammation

Outcome Measures

Primary Outcomes (1)

  • MACCE

    A composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, ischemia-driven revascularization

    12 months

Secondary Outcomes (9)

  • all-cause death

    12 months

  • cardiovascular death

    12 months

  • nonfatal myocardial infarction

    12 months

  • nonfatal stroke

    12 months

  • ischemia-driven revascularization

    12 months

  • +4 more secondary outcomes

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The hospitalized patients with coronary heart disease completing all planned PCI

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

plasma and whole blood cells

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Xiang Cheng, Doctor

    Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Miao Yu

CONTACT

+862785726009yumiaodavid@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study Record Dates

First Submitted

November 6, 2022

First Posted

November 14, 2022

Study Start

November 1, 2022

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

June 26, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)