The Usefulness of CaIMR in Patients With STEMI

NCT04984915 | Unknown

• 1 other identifier: 2021075
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

CaIMR; Prognosis; ST-segment Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• The composite endpoint of all-cause death and heart failure rehospitalization

  1 month after surgery

• All-cause death

  1 year after surgery

• All-cause death

  1 month after surgery

• Heart failure rehospitalization

  1 year after surgery

• Heart failure rehospitalization

  1 month after surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who meet the inclusion and exclusion criteria are included in the study.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongnan Hospital: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

Zhibing Lu, MD, PhD

CONTACT

8615997405817; luzhibing222@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The chief of cardiology department

Study Record Dates

• First Submitted: June 6, 2021
• First Posted: August 2, 2021
• Study Start: May 15, 2022
• Primary Completion: August 15, 2023
• Study Completion: December 1, 2023
• Last Updated: February 9, 2022

Record last verified: 2022-02

Locations

CN (1)