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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04984915
Other study ID # 2021075
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 15, 2022
Est. completion date December 1, 2023

Study information

Verified date February 2022
Source Zhongnan Hospital
Contact Zhibing Lu, MD, PhD
Phone 8615997405817
Email luzhibing222@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The coronary artery system is composed of three different types of blood vessels, namely epicardial arteries, arterioles and capillaries. Compared with epicardial arteries, arterioles and capillaries are lower than the resolution of current angiography systems, so angiography cannot be used for visualization. Existing studies have shown that coronary microcirculation plays an extremely important role in maintaining full myocardial perfusion. Coronary microvascular disorders can lead to myocardial hypoperfusion and ischemia, and are related to the poor prognosis of patients with coronary heart disease. At present, there is no technology that can directly detect the state of the coronary microcirculation in the human body, but the coronary microcirculation function can be indirectly assessed through two invasive and non-invasive methods. Among them, the index of microcirculation resistance (IMR) is widely used to evaluate coronary microcirculation function [3]. However, in the case of epicardial stenosis, accurate determination of IMR requires knowledge of coronary artery contraction pressure (Pw). However, measuring IMR is an invasive examination technique, and measuring IMR requires high technical requirements for the operator. Therefore, the CaIMR value obtained by AI technology can well overcome this limitation, and the existing data show that the CaIMR value has a good correlation with the IMR value. However, CaIMR has a clinical prognosis for patients with acute ST-segment elevation myocardial infarction. The predictive value of CaIMR has not yet been explored. This project aims to evaluate the application value of CaIMR in predicting the occurrence of adverse cardiovascular events in patients with acute ST-segment elevation myocardial infarction after percutaneous coronary intervention.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 400
Est. completion date December 1, 2023
Est. primary completion date August 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Patients who are clinically diagnosed with acute ST-segment elevation myocardial infarction and are planned to undergo PCI; - Volunteer to participate and sign the informed consent Exclusion Criteria: - Coronary angiography suggests that it is not suitable for PCI; - Have performed CABG surgery in the past; - Lesion of left or right coronary ostium; - The target vessel is an infarct-related artery (old or acute myocardial infarction recovery period); - The immediate effect of target vessel PCI is not ideal (such as: final TIMI blood flow <grade 3, dissection with restricted blood flow, side branch occlusion with diameter> 1.5 mm, distal embolism or thrombus shown by angiography); - Severe systemic infection; - Patients with malignant wasting disease whose estimated survival time is less than 1 year.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Zhongnan Hospital of Wuhan University Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Zhongnan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The composite endpoint of all-cause death and heart failure rehospitalization The composite endpoint of all-cause death and heart failure rehospitalization 1 year after surgery
Secondary The composite endpoint of all-cause death and heart failure rehospitalization The composite endpoint of all-cause death and heart failure rehospitalization 1 month after surgery
Secondary All-cause death All-cause death 1 year after surgery
Secondary All-cause death All-cause death 1 month after surgery
Secondary Heart failure rehospitalization Heart failure rehospitalization 1 year after surgery
Secondary Heart failure rehospitalization Heart failure rehospitalization 1 month after surgery
Secondary Cardiogenic Rehospitalization Cardiogenic Rehospitalization 1 year after surgery
Secondary Cardiogenic Rehospitalization Cardiogenic Rehospitalization 1 month after surgery
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