High-Frequency QRS for Predicting Microvascular Dysfunction and Adverse Events After PCI in Acute Myocardial Infarction

NCT07138638 | Not Yet Recruiting DMC

• 1 other identifier: XYFY2025-KL303-01
• Study Type: observational
• Target: 1,112
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study aimed to investigate the prognostic value of high-frequency QRS (HF-QRS) in patients with acute myocardial infarction (AMI) after percutaneous coronary intervention (PCI), as well as its potential role in diagnosing microvascular dysfunction. The main question it aims to answer is:

1. 1.Whether HF-QRS could serve as an effective tool for early identification of high-risk AMI patients and prognosis prediction;
2. 2.Whether HF-QRS provides auxiliary diagnostic value for post-AMI microvascular dysfunction.

Conditions

AMI

Keywords

Acute Myocardial Infarction; High-Frequency QRS; prediction model; Microvascular Dysfunction

Outcome Measures

Primary Outcomes (1)

• To evaluate the predictive value of high-frequency QRS (HF-QRS) parameters for major adverse cardiovascular events (MACE) within 1 year after PCI in AMI patients and to construct a prognostic risk prediction model.

  12 months

Secondary Outcomes (1)

• To evaluate the adjunctive diagnostic value of high-frequency QRS parameters for microvascular dysfunction in ACS patients following percutaneous coronary intervention

  12 months

Interventions

High-Frequency QRS DEVICE

All enrolled patients underwent HF-QRS assessment, with subsequent recording of MACE to evaluate the predictive value of HF-QRS parameters for clinical outcomes

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with acute myocardial infarction following percutaneous coronary intervention

You may qualify if:

• Aged 18 to 75 years (inclusive)
• Diagnosed with acute myocardial infarction (AMI, including STEMI and NSTEMI) and underwent successful emergency PCI
• Voluntarily participated and provided written informed consent

You may not qualify if:

• History of prior myocardial infarction or chronic heart failure
• QRS duration \>120 ms (including paced rhythm, WPW syndrome, bundle branch block, or left ventricular hypertrophy with repolarization abnormalities)
• Structural heart disease (congenital heart disease, cardiomyopathy, aortic dissection, etc.)
• Persistent atrial fibrillation or malignant arrhythmias
• History of cerebral hemorrhage or ischemic stroke within 1 month
• Prolonged cardiopulmonary resuscitation or requiring advanced life support (IABP/ECMO, etc.)
• Scheduled for imminent surgery with anticipated inability to complete HF-QRS assessment
• Refusal to participate in the clinical study

Sponsors & Collaborators

• The Affiliated Hospital of Xuzhou Medical University: lead

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

Location

Study Officials

• Yong Huo, Ph.D

  Department of Cardiology, Peking University First Hospital, Beijing, China

  STUDY CHAIR

• Yuan Lu, Ph.D

  The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu 221002

  STUDY DIRECTOR

Central Study Contacts

Yuan Lu, Ph.D

CONTACT

13952110901; 405983931@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 24, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)