Prognostic Value of the AMR Measured After PPCI in STEMI Patients

NCT05653765 | Active Not Recruiting DMC

• 1 other identifier: HenanICE202201
• Study Type: observational
• Target: 2,663
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Coronary Heart Disease; ST Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• MACEs

  cardiac death, hospitalization for heart failure, target vessel revascularization，non-fatal MI

  12 months

Secondary Outcomes (4)

• cardiac death

  12 months

• hospitalization for heart failure

  12 months

• target lesion revascularization

  12 months

• Repeated myocardial infarction

  12 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Aged 18 or older
• Type 1 myocardial infarction
• Receive PPCI

You may not qualify if:

• 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

Sponsors & Collaborators

• Henan Institute of Cardiovascular Epidemiology: lead

Study Sites (5)

Shangqiu first people's Hospital

Shangqiu, Henan, 476000, China

Location

Department of Cardiology, First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

Location

Yongcheng Central Hospital

Yongcheng, Henan, China

Location

Fuwai central China cardiovascular Hospital

Zhengzhou, Henan, China

Location

Renji Hospital, School of Medicine, Shanghai Jiao Tong University,

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Coronary Disease; ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Study Officials

• Muwei Li, MD

  Fuwai central China cardiovascular hospotial

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: December 16, 2022
• Study Start: December 20, 2022
• Primary Completion: December 20, 2023
• Study Completion: March 20, 2025
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)