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A Flexible Hemodynamic Multi-Parameter Ultrasonic Array Sensor for Myocardial Infarction Diagnosis, Early Warning, and Monitoring

A Flexible Hemodynamic Multi-Parameter Ultrasonic Array Sensor for Myocardial Infarction Diagnosis, Early Warning, and Monitoring

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600118773
Enrollment
Unknown
Registered
2026-02-10
Start date
2026-02-10
Completion date
Unknown
Last updated
2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

Interventions

Gold Standard:Coronary Angiography: Coronary artery stenosis severity is classified into Grades 0–VI (Analysis of Acute Myocardial Infarction Diagnosis by Coronary Angiography). The degree of stenosis
Index test:Flexible Hemodynamic Multi-Parameter Ultrasonic Array Sensor(S3-64)

Sponsors

Air Force Medical Center of the Chinese People's Liberation Army
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Study 1: 1. This study does not restrict by gender; 2. Patients presenting with typical ischemic chest pain (lasting =10 minutes, consistent with angina characteristics) or equivalent symptoms (such as unexplained acute dyspnea, nausea and vomiting, profuse sweating, syncope, etc.) who are highly suspected of having acute coronary syndrome (ACS); 3. Age >18 years; 4. Underwent echocardiography after admission; 5. Underwent coronary angiography before discharge. Study 2: 1. Healthy subject group: (1) This study does not restrict by gender; (2) No history of cardiovascular disease; (3) Age >18 years; (4) No hypertension, diabetes, or severe pulmonary, liver, or kidney disease; (5) Normal or basically normal electrocardiogram; (6) Normal echocardiography (LVEF>55%, no regional wall motion abnormalities, no significant valvular disease, etc.); (7) Informed consent provided by the individual or their legal representative. 2. Myocardial infarction patient group: (1) Meets the diagnostic criteria for acute myocardial infarction (STEMI or NSTEMI) according to the latest international guidelines and is in the acute phase (within 24 hours of onset); (2) Hemodynamically relatively stable (no persistent cardiogenic shock, severe hypotension, or malignant arrhythmias) and able to tolerate short non-invasive examinations; (3) Age >18 years; (4) Informed consent provided by the patient or their legal representative. Study 3: 1. This study does not restrict by gender; 2. Patients presenting with typical ischemic chest pain (lasting =10 minutes, consistent with angina characteristics) or equivalent symptoms (such as unexplained acute dyspnea, nausea and vomiting, profuse sweating, syncope, etc.) who are highly suspected of having acute myocardial infarction; 3. Within 24 hours of symptom onset; 4. Hemodynamically relatively stable (no persistent cardiogenic shock, severe hypotension, or malignant arrhythmias) and able to tolerate short non-invasive examinations; 5. Age >18 years; 6. Planned to undergo coronary angiography; 7. Informed consent provided by the patient or their legal representative.

Exclusion criteria

Exclusion criteria: Study 1 1. Incomplete clinical data; 2. Presence of other severe cardiac diseases such as valvular disease, cardiomyopathy, or congenital heart disease; 3. History of myocardial infarction. Study 2 1. Healthy subjects group: (1) Pregnant or breastfeeding women; (2) Morbid obesity (BMI >= 35 kg/m^2); (3) Currently taking medications that may significantly affect cardiovascular parameters (e.g., beta-blockers, cardiotonic drugs, etc.); 2. Myocardial infarction patient group: (1) Hemodynamically unstable (e.g., cardiogenic shock, severe hypotension, persistent ventricular tachycardia/ventricular fibrillation); (2) Morbid obesity (BMI >= 35 kg/m^2); (3) Currently taking medications that may significantly affect cardiovascular parameters (e.g., beta-blockers, cardiotonic drugs, etc.); Study Three 1. Hemodynamic or clinical instability (e.g., cardiogenic shock, severe hypotension, persistent ventricular tachycardia/ventricular fibrillation); 2. Presence of severe valvular disease, cardiomyopathy, congenital heart disease, or other cardiac conditions; 3. Severe obesity: BMI >= 35 kg/m^2; 4. Pregnant or breastfeeding women; 5. Planned early discharge or transfer (or other situations where continuous monitoring cannot be maintained); 6. History of myocardial infarction.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;

Countries

China

Contacts

Public ContactXi Liu

Air Force Medical Center of the Chinese People's Liberation Army

liuxi916@126.com+86 176 1168 6393

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026