Intervention of Acute Myocardial Infarction with integrated traditional Chinese Medicine and Western Medicine: a Randomized Controlled Trial.
- Conditions
- acute myocardial infarction
- Registration Number
- ITMCTR2000003494
- Lead Sponsor
- Qilu Hospital of Shandong University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
(1) Aged 30-75 years;
(2) Patients with STEMI (cTnI peak > 99% URL) in emergency admission who meet the global definition of AMI (version 4) have a rise and fall curve, and have clinical evidence of myocardial ischemia. (see Annex 1 for detailed definition)
(3) All patients had received emergency PCI, and TIMI blood flow classification of infarct related artery reached level 3 within 5 days after PCI;
(4) Volunteered to participate in this study and informed consent has been signed.
(1) AMI with uncontrolled severe acute heart failure ;
(2) AMI with cardiogenic shock (Killip grade >= I+II), no response to vasopressin;
(3) AMI with severe arrhythmia (sustained ventricular tachycardia, ventricular fibrillation), atrioventricular block above grade II, and rapid atrial fibrillation;
(4) AMI with mechanical complications (perforation of ventricular septum, rupture of papillary muscle, thrombus in cardiac cavity, rupture of free wall of ventricle);
(5) Serious systemic diseases (serious infection, massive hemorrhage caused by anticoagulation and antithrombotic therapy, 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 > 134 µ mol / 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 ingredients of this study;
(12) Pregnant or lactating women;
(13) Patients who participated in other clinical studies of traditional Chinese medicine within three months before selection;
(14) Other diseases with clinical significance may cause serious risks to patients.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method VESVi;LVEDVi;
- Secondary Outcome Measures
Name Time Method Composite endpoint incidence of cardiovascular events;LVEF, E/e', LAV, GLS;cTnI, NT-proBNP, ST2;