The Usefulness of CaIMR in Patients With STEMI

Prognosis Clinical Trial

Official title:

The Long-term Prognostic Value of CaIMR in Patients With ST-segment Elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04984915
• Other study ID #: 2021075
• Status: Not yet recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Prognosis
• ST Elevation Myocardial Infarction
• ST-segment Elevation Myocardial Infarction

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