Artificial Intelligence in Detecting Cardiac Function

NCT06444425 | Enrolling By Invitation

• 1 other identifier: KY-2024-108
• Study Type: observational
• Target: 685
• Locations: 1 country
• Sites: 1

Brief Summary

The Korotkoff Sounds（KS）, which have been in use for over a century, are widely regarded as the gold standard for measuring blood pressure. Furthermore, their potential extends beyond diagnosis and treatment of cardiovascular disease; however, research on the KS remains limited. Given the increasing incidence of heart failure (HF), there is a pressing need for a rapid and convenient prehospital screening method. In this study, we propose employing deep learning (DL) techniques to explore the feasibility of utilizing KS methodology in predicting functional changes in cardiac ejection fraction (LVEF) as an indicator of cardiac dysfunction.

Conditions

Heart Failure; Deep Learning

Outcome Measures

Primary Outcomes (1)

• Cardiac Dysfunction

  The pathophysiology of heart failure encompasses a multifaceted clinical syndrome: 1)Cardiac structural and/or functional abnormalities resulting in impaired ventricular diastolic function and/or systolic ejection capacity;2)Corresponding clinical manifestations indicative of heart failure; 3)Typically accompanied by elevated levels of beneficial natriuretic peptide(BNP), as well as pulmonary or systemic congestion suggestive of cardiac origin on imaging studies, or objective evidence of increased ventricular filling pressure on hemodynamic assessments.4)According to the classification of left ventricular ejection fraction (LVEF) based on cardiac ultrasound, heart failure can be categorized into four types: reduced ejection fraction heart failure (HFrEF), improving ejection fraction heart failure (HFimpEF), moderately reduced ejection fraction heart failure (HFmrEF), and retained ejection fraction heart failure (HFpEF).

  Evaluation LVEF：Cardiac ultrasound was performed 72 hours prior to and following anti-Acute Heart Failure treatment.

Study Arms (2)

Heart Failure

Patients with stable heart failure were defined as those with structural heart disease and a history of heart failure episodes but no current symptoms or signs of heart failure after receiving anti-heart failure treatment during hospitalization, such as decreased exercise tolerance (dyspnea, fatigue), fluid retention, etc. Additionally, according to the 2024 Chinese guidelines for the diagnosis and treatment of heart failure consensus, patients eligible for this study will be classified based on ejection fraction into the following categories: * Reduced ejection fraction heart failure (HFrEF): HFrEF is defined by LVEF \< 40% * Preserved ejection fraction heart failure (HFpEF): HFpEF is defined by LVEF ≥ 50% * Heart failure with mid-range ejection fraction (HFmrEF): HFmrEF refers to heart failure characterized by LVEF between 40% and 49%.

Normal

There were no structural or functional abnormalities in the cardiac system, and no symptoms or signs of heart failure were observed. Alternatively, the patient has developed organic heart disease without exhibiting any symptoms or signs of heart failure.

Eligibility Criteria

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

Study Population

Patients who were admitted to the Cardiology Department of the aforementioned four Groups (The Fourth Affiliated Hospital of School of Medicine of Zhejiang University, Zhejiang Taizhou Hospital, Quzhou People\&amp;#39;s Hospital, Zhejiang Quhua Hospital) between June 2024 and December 2024, and successfully underwent echocardiographic examinations.

You may qualify if:

• Patients who were admitted to the Cardiology Department of the aforementioned four Groups (The Fourth Affiliated Hospital of School of Medicine of Zhejiang University, Zhejiang Taizhou Hospital, Quzhou People\&amp;#39;s Hospital, Zhejiang Quhua Hospital)between June 2024 and December 2024, and successfully underwent echocardiographic examinations.
• Individuals aged between 18 and 90 years with a resting heart rate ranging from 60 to 100 beats per minute.
• Demonstrating good compliance, capable of cooperating in completing multiple blood pressure measurements within 72 hours following the completion of echocardiography.
• Willingness to voluntarily participate in the study.

You may not qualify if:

• Patients with acute decompensated heart failure, acute myocardial infarction, atrioventricular block;
• Cerebral hemorrhage, severe infection, active digestive tract ulcer, severe hematological diseases, severe liver and kidney dysfunction or other serious medical or surgical conditions;
• Pregnant or lactating women;
• Patients with mental illness;
• Individuals who have participated in other clinical trials within the past 3 months.

Sponsors & Collaborators

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine: lead
• Zhejiang Taizhou hospital: collaborator
• The People's Hospital of Quzhou: collaborator
• Zhejiang Quhua Hospital: collaborator
• Hong Kong Applied Science and Technology Research Institute: collaborator

Study Sites (1)

The Fourth Hospital Affiliated to Zhejiang University School of Medicine

Yiwu, Zhejiang, 322000, China

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Sixiang Jia, MD

  The fourth hospital affiliated to zhejiang university school of medicine

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 5, 2024
• Study Start: June 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)