Prognostic Value of the AMR Measured After PPCI in STEMI Patients (EARLYMYOAMR)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: ST Elevation Myocardial Infarction; Coronary Heart Disease

• Study Type: Observational
• Enrollment (Actual): 2663

Contacts and Locations

Study Locations

• China
  • Henan
    • Shangqiu, Henan, China, 476000
      • Shangqiu First People's Hospital
    • Xinxiang, Henan, China
      • Department of Cardiology, First Affiliated Hospital of Xinxiang Medical University
    • Yongcheng, Henan, China
      • Yongcheng Central Hospital
    • Zhengzhou, Henan, China
      • Fuwai Central China Cardiovascular Hospital
  • Shanghai
    • Shanghai, Shanghai, China
      • Renji Hospital, School of Medicine, Shanghai Jiao Tong University,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients who underwent PPCI due to STEMI in several chest pain centers in China from January 1, 2012 to October 1, 2022

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
diagnostic cohort/derivation cohort; The diagnostic/derivation cohort included STEMI patients who underwent PCI within 12 hours and CMR. The optimal AMR cutoff value for diagnosing CMD using CMR was determined by analyzing ROC curves.
prognostic cohort/validation cohort; The prognostic cohort enrolled STEMI patients who underwent PPCI within 12 hours. All patients were followed up for at least 1 year.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACEs	cardiac death, hospitalization for heart failure, target vessel revascularization，non-fatal MI	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiac death	All cause deaths will be considered cardiac unless a definite noncardiac cause can be established.	12 months
hospitalization for heart failure	Hospitalization for heart failure was defined as admission because of new or deteriorating signs and symptoms of heart failure combined with the findings of noninvasive imaging or elevated B-type natriuretic peptide(BNP) and/or N-terminal pro-BNP concentration, and a discharge diagnosis of congestive heart failure.	12 months
target lesion revascularization	The following 3 conditions need to be met at the same time: The new stenosis that developed within previously treated coronary segments and within 5 mm of their borders;; The new stenosis resulted in the vessel μQFR ≤ 0.80;; The patient subsequently underwent repeat PCI or coronary artery bypass grafting (CABG).	12 months
Repeated myocardial infarction	Repeated myocardial infarction	12 months

Collaborators and Investigators

• Sponsor: Henan Institute of Cardiovascular Epidemiology
• Investigators: Study Chair: Muwei Li, MD, Fuwai central China cardiovascular hospotial

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2022
• Primary Completion (Actual): December 20, 2023
• Study Completion (Estimated): March 20, 2025

Study Registration Dates

• First Submitted: November 4, 2022
• First Submitted That Met QC Criteria: December 14, 2022
• First Posted (Actual): December 16, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Necrosis; Arteriosclerosis; Arterial Occlusive Diseases; Ischemia; ST Elevation Myocardial Infarction; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Myocardial Infarction; Infarction
• Other Study ID Numbers: HenanICE202201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The personal information of a large number of patients is involved. IPD is not provided to protect the privacy of participants.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No