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NCT04239404 Clinical Trial

Prognostic Impact of PMI in Stable CAD Undergoing PCI

Coronary Artery Disease Clinical Trial

Official title:
The Prognostic Impact of Periprocedural Myocardial Injury in Stable Coronary Artery Disease Patients Undergoing Elective Percutaneous Coronary Intervention

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04239404
Other study ID # PMI-CAD-PCI
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date May 2021

Study information
Verified date January 2020
Source Shanghai Zhongshan Hospital
Contact Zhangwei Chen, MD
Phone +86 21 64041990
Email chen.zhangwei@zs-hospital.sh.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a single-center, observational, prospective study. This study aims to observe the effect of periprocedural myocardial injury on cardiovascular events in patients undergoing elective percutaneous coronary intervention, and to detect the levels of serum inflammatory factors before and after intervention to predict the occurrence of periprocedural myocardial injury and its association with cardiovascular events.

Recruitment information / eligibility
Status Recruiting
Enrollment 2000
Est. completion date May 2021
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- underwent elective coronary stenting

- patients permit informed consents

Exclusion Criteria:

- acute STEMI

- NYHA class III-IV heart failure

- moderate-to-severe valvular disease

- missing post-PCI troponin results

- active infection, respiratory failure

- liver dysfunction (liver enzyme >3xURL or bilirubin >2xURL),

- malignancy and systemic connective tissue disease

- unable to get a informed consents

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China 180 Fenglin Road Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Major cardiac events cardiac death, target vessel revascularization, target lesion revascularization, non-fatal myocardial infarction, heart failure, angina pectoris 12 months after PCI
Secondary Serum level of inflammatory factors Serum level of inflammatory factors including TNFa, IL-6 and so on. 1 day after PCI
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