Prognostic Value of the AMR Measured After PPCI in STEMI Patients

Coronary Heart Disease Clinical Trial

Official title:

Prognostic Value of the Angio-based Microvascular Resistance Use One Single Angiographic View Measured After Primary Percutaneous Coronary Intervention in ST-segment Elevation Myocardial Infarction Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05653765
• Other study ID #: HenanICE202201
• Status: Recruiting
• Start date: December 20, 2022
• Est. completion date: March 20, 2024

Study information

• Verified date: November 2023
• Source: Henan Institute of Cardiovascular Epidemiology
• Contact: Quan Guo, MD
• Phone: +8615670510031
• Email: xinyiguoquan[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to learn about in STEMI with Primary PCI Patients. The main questions it aims to answer are:

• To determine the value of AMR in predicting the long-term clinical prognosis of patients with STEMI after PPCI, and to find the best cut-off value.

• Analyze the factors of PPCI affecting AMR and explore the effective measures of PPCI microcirculation protection.

Radiographic images of STEMI receiving primary PCI treatment in several chest pain centers in China will be included. The last image of the infarct-related vessel will be used as a target to calculate its AMR. The relationship between AMR and long-term clinical prognosis was analyzed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: March 20, 2024
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged 18 or older

• Type 1 myocardial infarction

• Receive PPCI

Exclusion Criteria:

• Failed to identify culprit vessels.

• Structural heart disease with moderate to severe aortic valve or mitral regurgitation and or stenosis that may affect cardiac function

• Dialysis patients with severe renal insufficiency

• Severe and uncontrollable arrhythmia

• Complicated with dilated cardiomyopathy

• Unable to tolerate dual antiplatelet therapy

• Severe and uncontrollable anemia

• Hyperthyroidism

• TIMI blood flow 0-1 grade after PPCI

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Infarction
• Myocardial Infarction
• Myocardial Ischemia
• ST Elevation Myocardial Infarction

Locations

Country	Name	City	State
China	Renji Hospital, School of Medicine, Shanghai Jiao Tong University,	Shanghai	Shanghai
China	Shangqiu first people's Hospital	Shangqiu	Henan
China	Department of Cardiology, First Affiliated Hospital of Xinxiang Medical University	Xinxiang	Henan
China	Fuwai central China cardiovascular Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Institute of Cardiovascular Epidemiology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACEs	cardiac death, hospitalization for heart failure, target vessel revascularization,non-fatal MI	12 months
Secondary	cardiac death	Rates of individual components of MACE	12 months
Secondary	hospitalization for heart failure	Rates of individual components of MACE	12 months
Secondary	target vessel revascularization	Rates of individual components of MACE	12 months
Secondary	non-fatal MI	Rates of individual components of MACE	12 months