HsCRP in the Prognosis of Patients After PCI：a Multi-center Study

hsCRP Clinical Trial

Official title:

High-sensitivity C-reactive Protein (hsCRP) in the Prognosis of Patients After Coronary Intervention (PCI) : a Multi-center Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05614050
• Other study ID #: Multicenter-CRP
• Status: Recruiting
• Start date: November 1, 2022
• Est. completion date: November 1, 2024

Study information

• Verified date: July 2023
• Source: Wuhan Union Hospital, China
• Contact: Miao Yu
• Phone: +862785726009
• Email: yumiaodavid[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Coronary heart 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 on MACCE in PCI population remains unclear. Therefore, in this study, the investigators plan to recruit patients undergoing PCI, and observe the impact of RIR by serial hsCRP measurements on the prognosis of these patients followed up for 1 years at 14 hospitals in China.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2400
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• hsCRP

Locations

Country	Name	City	State
China	Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (21)

Lead Sponsor

Collaborator

Wuhan Union Hospital, China

Central Hospital of Enshi Tujia and Miao Autonomous Prefecture, Chinese Academy of Medical Sciences, Fuwai Hospital, Fifth Hospital in Wuhan, Jingzhou Central Hospital, Shandong Provincial Hospital, Shanxi Cardiovascular Hospital, Suizhou Central Hospital, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Xiamen University, The First Affiliated Hospital of Zhengzhou University, The First Hospital of Wuhan, The Third Xiangya Hospital of Central South University, Tianjin Medical University General Hospital, Wuhan Asia Heart Hospital, Wuhan Central Hospital, Wuhan Fourth Hospital, Wuhan Union Hospital Jinyinhu Campus, Wuhan Union Hospital West Campus, Xiangyang First People's Hospital, Yichang Central People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACCE	A composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, ischemia-driven revascularization	12 months
Secondary	all-cause death	Occurrence of all-cause death	12 months
Secondary	cardiovascular death	Occurrence of cardiovascular death	12 months
Secondary	nonfatal myocardial infarction	Occurrence of nonfatal myocardial infarction	12 months
Secondary	nonfatal stroke	Occurrence of of nonfatal stroke	12 months
Secondary	ischemia-driven revascularization	Occurrence of ischemia-driven revascularization	12 months
Secondary	hospitalization for unstable angina	Occurrence of hospitalization for unstable angina	12 months
Secondary	stent/scaffold thrombosis	Occurrence of stent/scaffold thrombosis	12 months
Secondary	in-stent restenosis	Occurrence of in-stent restenosis	12 months
Secondary	bleeding	Occurrence of bleeding	12 months