AMINCT07138638
High-Frequency QRS for Predicting Microvascular Dysfunction and Adverse Events After PCI in Acute Myocardial Infarction
An observational study of AMI, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- AMI
- What is being tested?
- High-Frequency QRS
- Type of treatment
- Medical device
- How many people
- 1,112 participants
- Where
- 1 siteChina
- Study dates
- Aug 2025to Dec 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with acute myocardial infarction following percutaneous coronary intervention
Who may be able to join
- 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
Who cannot join
- 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.)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
Yuan Lu, Ph.D, 13952110901, 405983931@qq.com
About this study
Official title: High-Frequency QRS for Predicting Microvascular Dysfunction and Adverse Events After PCI in Acute Myocardial Infarction: A Prospective, Multicenter Cohort Study
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:
- Whether HF-QRS could serve as an effective tool for early identification of high-risk AMI patients and prognosis prediction;
- 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).
- Conditions
- AMI
- Being tested
- High-Frequency QRS
- Keywords
- Acute Myocardial Infarction, High-Frequency QRS, prediction model, Microvascular Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Frequency QRSDevice
All enrolled patients underwent HF-QRS assessment, with subsequent recording of MACE to evaluate the predictive value of HF-QRS parameters for clinical outcomes
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,112 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yong Huo, Ph.D, Study chair, Department of Cardiology, Peking University First Hospital, Beijing, ChinaYuan Lu, Ph.D, Study director, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu 221002
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07138638
- Sponsor's protocol ID
- XYFY2025-KL303-01
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Frequency QRS for Predicting Microvascular Dysfunction and Adverse Events After PCI in Acute Myocardial Infarction: A Prospective, Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT07138638
- Acronym / sponsor ID
- XYFY2025-KL303-01
- Conditions
- AMI
- Keywords
- Acute Myocardial Infarction, High-Frequency QRS, prediction model, Microvascular Dysfunction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,112 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Whether HF-QRS could serve as an effective tool for early identification of high-risk AMI patients and prognosis prediction;
- 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with acute myocardial infarction following percutaneous coronary intervention
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Frequency QRSAll enrolled patients underwent HF-QRS assessment, with subsequent recording of MACE to evaluate the predictive value of HF-QRS parameters for clinical outcomes | Device | – |
Primary outcome
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.
Time frame: 12 months
1 secondary outcome
To evaluate the adjunctive diagnostic value of high-frequency QRS parameters for microvascular dysfunction in ACS patients following percutaneous coronary intervention
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yong Huo, Ph.D study chair
Department of Cardiology, Peking University First Hospital, Beijing, China
Yuan Lu, Ph.D study director
The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu 221002
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AMI, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuan Lu, Ph.D (13952110901, 405983931@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.