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

NCT ID: NCT07138638

Last Updated: 2025-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1112 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-31

Study Completion Date

2027-12-31

Brief Summary

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

Participants underwent HF-QRS assessment and were prospectively followed for 1 year to record the incidence of major adverse cardiovascular events (MACE).

Detailed Description

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Conditions

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AMI

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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High-Frequency QRS

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Other life-threatening conditions including: Severe hepatic or renal dysfunction;Uncontrolled systemic diseases;Hematologic disorders;Active infections;Malignancy with life expectancy \<1 year Other investigator-determined exclusionary conditions:Pregnancy;Concurrent participation in other clinical trials

Refusal to participate in the clinical study
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Hospital of Xuzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yong Huo, Ph.D

Role: STUDY_CHAIR

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

Yuan Lu, Ph.D

Role: STUDY_DIRECTOR

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

Locations

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The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Site Status

Countries

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China

Central Contacts

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Yuan Lu, Ph.D

Role: CONTACT

13952110901

Facility Contacts

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Yuan Lu, Ph.D

Role: primary

13952110901

Other Identifiers

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XYFY2025-KL303-01

Identifier Type: -

Identifier Source: org_study_id

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