Ignite Creation Date:
2024-05-06 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05131750
Status:
RECRUITING
Last Update Posted:
2023-12-22
First Post:
2021-05-03
Brief Title:
RIR and the Impact on Clinical Outcomes in Patients Undergoing PCI
Sponsor:
Wuhan Union Hospital China
Organization:
Wuhan Union Hospital China
Study Overview
Official Title:
A Prospective Study of Residual Inflammatory Risk and the Impact on Clinical Outcomes in Patients Undergoing Percutaneous Coronary Interventions
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 events MACE
At present the concept of residual inflammation risk RIR has aroused widespread concern RIR is an important independent risk in patients with CAD Foreign studies indicate that hsCRP 2mg L is the definition standard of RIR in CAD In China there is no defined value of RIR for patients undergoing PCI and the incidence of RIR has not been investigated clearly At the same time the impact of dynamic changes of hsCRP on MACE in PCI population needs to be further explored Therefore in this study we 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 5 years
At present the concept of residual inflammation risk RIR has aroused widespread concern RIR is an important independent risk in patients with CAD Foreign studies indicate that hsCRP 2mg L is the definition standard of RIR in CAD In China there is no defined value of RIR for patients undergoing PCI and the incidence of RIR has not been investigated clearly At the same time the impact of dynamic changes of hsCRP on MACE in PCI population needs to be further explored Therefore in this study we 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 5 years
Detailed Description:
Serial hsCRP measurements with 4 weeks between both measurements are defined in this analysis Time-to-event is measured from first hsCRP measurement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None