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Randomized controlled clinical study on Yiqi Liangxue Shengji prescription for intervention cardiac function of acute myocardial infarction with ischemia-reperfusion injury

Capital health development research project

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038816
Enrollment
Unknown
Registered
2020-10-04
Start date
2020-11-01
Completion date
Unknown
Last updated
2021-01-05

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

Conditions

Acute myocardial infarction

Interventions

Sponsors

Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients who met the diagnostic criteria of AMI were successfully treated with PCI and revascularization; 2. At least one of the diagnostic criteria of ischemia-reperfusion injury was met; (1) The symptoms of myocardial ischemia worsened or myocardial infarction occurred again after opening the occluded vessel during PCI and revascularization; (2) Coronary angiography showed slow flow, no reflow, small branch occlusion, TIMI <= 2, or complicated with thrombosis, dissection or spasm; (3) Atrial and ventricular arrhythmias, bradycardia, delayed ST segment depression and new ST segment elevation were found in ECG; (4) Decreased diastolic function or new wall motion abnormalities detected by echocardiography; (5) Myocardial radionuclide perfusion imaging revealed new viable myocardium loss or abnormal wall motion. 3. Patients with Qi deficiency and blood stasis syndrome in TCM; 4. Patients aged 18-80 years old; 5. Patients who voluntarily participate and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with acute complications of PCI (malignant arrhythmias such as cardiogenic shock and ventricular fibrillation after cardiopulmonary resuscitation, valve prolapse caused by rupture of chordae tendineae / papillary muscle, heart rupture, coronary artery perforation, pericardial tamponade, continuous IABP assistance for cardiogenic shock, continuous pacemaker assistance for severe bradycardia, continuous heart failure that cannot be relieved by drugs, etc.); 2. Patients with refractory hypertension, systolic blood pressure >= 180mmhg or diastolic blood pressure >= 110mmhg; 3. Severe liver dysfunction (alanine aminotransferase >= 1.5 times normal), renal dysfunction (serum creatinine >= 194.5 umol / L), serum potassium level >= 5.5 mmol / L, primary disease of blood system, malignant tumor, severe complications of diabetes mellitus, hyperthyroidism, hypothyroidism and other serious secretory diseases; 4. Patients with severe consumption or malignant tumor; 5. Patients with new cerebral hemorrhage within 6 months; 6. Patients with bleeding, trauma or active peptic ulcer within one month; 7. Suspected or definite allergy to the test drug; 8. Pregnant or lactating women or objects with pregnancy plans; 9. Patients with mental diseases and infectious diseases; 10. Subjects who participated in other clinical studies in recent one month; 11. Subjects who have used any traditional Chinese medicine and proprietary Chinese medicine preparations in recent 4 weeks.

Design outcomes

Secondary

MeasureTime frame
Myocardial injury markers;Plasma mirna-145 levels;Angina symptom score;Curative effect of TCM Syndrome;MACE events;

Primary

MeasureTime frame
NT- proBNP;LVEF;

Countries

China

Contacts

Public ContactLi Dong

Dongfang Hospital Affiliated to Beijing University of Chinese Medicine

dongdong871103@163.com+86 15201489469

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026