Clinical study on the treatment of myocardial remodeling after acute myocardial infarction by integrated traditional Chinese and western medicine

Phase 4

Recruiting

• Conditions: acute myocardial infarction

• Registration Number: ITMCTR2100005045
• Lead Sponsor: Qilu Hospital of Shandong University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Aged 30 to 75 years;
2. Emergency admission STEMI patients who meet the 4th edition of the global definition of AMI (cTnI peak value > 99% upper limit of the reference value (URL) and have an ascending and descending curve, and have clinical evidence of myocardial ischemia.
3. All patients have received emergency PCI, and the infarct-related arterial TIMI blood flow classification has reached grade 3, within 10 days after PCI;
4. Voluntarily participate in this study and have signed the informed consent.

Exclusion Criteria

1. AMI combined with severe acute heart failure uncontrolled;
2. AMI combined with cardiogenic shock (Killip grade >= grade III), who did not respond to vasopressors;
3. AMI complicated with severe arrhythmia (sustained ventricular tachycardia, ventricular fibrillation), second-degree or higher atrioventricular block, and rapid atrial fibrillation;
4. AMI complicated with mechanical complications (ventricular septal perforation, papillary muscle rupture, cardiac thrombus, ventricular free wall rupture);
5. Severe systemic diseases (severe infection, massive hemorrhage due to anticoagulation and antithrombotics, respiratory failure);
6. History of cerebral hemorrhage and cerebral aneurysm within 3 months;
7. Severe hepatic and renal insufficiency [ALT >= 3 ULN (Upper Limit of Normal), Cr > 134µmol/L (2mg/dl) or eGFR < 45ml/min/1.73m2].
8. Patients with neuropsychiatric diseases;
9. Malignant tumor;
10. Other pathophysiological states with expected survival less than 1 year;
11. Those who are allergic to the components of the drug in this study;
12. Pregnant or lactating women;
13. Patients who participated in other clinical studies of traditional Chinese medicine within the first three months;
14. Other diseases of clinical significance, etc., may cause serious danger to the patient.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eft ventricular end-diastolic volume;Left ventricular end-systolic volume;

Secondary Outcome Measures

Name	Time	Method
Global longitudinal strain of left ventricle;Incidence of compound end points of cardiovascular events;left ventricular ejection fraction;left atrial volume;Global longitudinal strain of left atrium;