Development and Validation of a Risk Prediction Model for Ischemic Stroke in Acute Myocardial Infarction Without Comorbid Atrial Fibrillation

NCT07171892 | Not Yet Recruiting

• 1 other identifier: 2025/Project No. 142RS
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief Summary

Study Goal: This observational study aims to develop a tool to predict the risk of ischemic stroke(stroke caused by a blood clot) in people who survive a heart attack and do not have irregular heartbeats (atrial fibrillation) . Key Questions: Can we create an accurate tool using existing hospital records to identify which heart attack survivors without irregular heartbeats have the highest risk of stroke while still in the hospital? Can this tool reliably predict stroke risk at 3 months and 1 year after leaving the hospital? About Participation: This study will only use information from past patient medical records. If you had a heart attack and were treated at our hospital between January 1, 2014, and December 31, 2023 , and you did not have irregular heartbeats (atrial fibrillation), your anonymous health information might be included in this analysis. No new patients are being recruited. This study analyzes existing information only. No one will be asked to do anything new. We will not contact patients directly. What Information Will Be Used? Researchers will securely review past hospital records to look at information doctors usually collect during heart attack care, such as: Your age and medical history (like previous strokes, diabetes, high blood pressure, kidney problems). Test results (like heart pumping strength). Treatment details after your heart attack. Information on whether you had a stroke later. All personal details (like name, ID number) will be permanently removed to protect privacy. Why This Matters: People who survive a heart attack have a higher risk of stroke later, even without the common irregular heartbeat condition. A stroke can be life-threatening or seriously impact quality of life. This tool aims to help doctors in the future better understand a patient's individual stroke risk after a heart attack, so preventative steps can be discussed if needed. Ethics \& Safety: Approved: This study has been reviewed and approved by our hospital's Ethics Committee to ensure it is safe and ethical. Privacy Guaranteed: Your personal identity is protected. All data is stored securely on the hospital's protected network with strict access controls. No personal information leaves the hospital. Researcher Note: This tool is currently for research purposes only. It will not be used for your medical care right now. If doctors want to use this tool in future clinical practice, a new study directly involving patients with their informed consent would be required.

Conditions

Myocardial Infarction

Keywords

Clinical Prediction Model

Outcome Measures

Primary Outcomes (2)

• calibration

  Calibrationevaluates how closely predicted probabilities match actual observed outcomes in a prediction model. It measures whether a model's confidence in its predictions reflects reality.

  3 months, 5 years

• AUC

  A standard metric to evaluate the performance of classification models.

  3 months, 5 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Previously diagnosed with acute myocardial infarction, with no history of atrial fibrillation. Relevant investigations demonstrated no evidence of atrial fibrillation

You may qualify if:

• myocardial infarction without atrial fibrillation

You may not qualify if:

• Thrombophilia
• Paradoxical Embolism through a Patent Foramen Ovale (PFO)
• Iatrogenic embolism
• Coronary slow-flow phenomenon
• Coronary vasospasm
• Dissection,

Sponsors & Collaborators

• First Affiliated Hospital of Ningbo University: lead
• The Affiliated Hospital of Medical College, Ningbo University: collaborator

Study Sites (1)

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 315010, China

Location

Related Links

• Adopting the methodological approach described in this study

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Study Officials

• Hanbin Cui, Doctor

  First Affiliated Hospital of Ningbo University

  STUDY DIRECTOR

Central Study Contacts

Jinsong Cheng, Doctor

CONTACT

+86 15867811402; charliecjs@163.com

Hanbin Cui, Doctor

CONTACT

+86 13606581566; hbcui_nbdyyy@outlook.com

Study Design

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

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 15, 2025
• Study Start: October 21, 2025
• Primary Completion: November 21, 2025
• Study Completion: November 30, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Locations

CN (1)