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Clinical study on the intervention of Yiqi Huoxue Formula on myocardial injury after reperfusion: a randomized controlled study

Study on the clinical application of Yiqi Huoxue Formula in interfering with ischemia-reperfusion injury and its mechanism of inhibiting myocardial pyroptosis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002562
Enrollment
Unknown
Registered
2025-12-27
Start date
2025-08-01
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

acute myocardial infarction

Interventions

The Yiqi Huoxue Formula Group:The patients in Yiqi Huoxue Formula groupFollow the guidelines for conventional Western medical treatment and take the decoction of the Yiqi Huoxue Formula orally after
Control group:Follow the guidelines for conventional Western medical treatment

Sponsors

Suqian Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Aged more than 18 years old and less than 80 years old; (2) The time from the onset of chest pain and chest tightness to treatment is =12 hours; (3) Electrocardiogram (ECG) diagnostic criteria for STEMI: ST segment elevation =0.1mV in two or more adjacent limb leads or ST segment elevation =0.2mV in two or more adjacent precordial leads; (4) Coronary angiography, CAG) shows: the forward blood flow of the infarct-related artery is TIMI grade 1 or 0; (5) Patients diagnosed with Qi deficiency and blood stasis syndrome according to TCM standards.

Exclusion criteria

Exclusion criteria: (1) Previous coronary artery bypass grafting (CABG); (2) History of old myocardial infarction; (3) History of severe heart failure (NYHA class III-IV); (4) Patients who are not suitable for PCI as shown by coronary angiography, such as severe tortuous calcification of the coronary arteries and severe three-vessel disease; (5) Combined with a history of severe liver insufficiency, severe kidney disease (eGFR<30ml/min/1.73m2); (6) Combined with acute inflammation, advanced malignant tumors, infectious diseases, bleeding disorders, electrolyte disorders, autoimmune diseases, severe tissue damage, etc.; (7) Patients with concurrent cardiac arrest and cardiogenic shock; (8) Patients allergic to contrast agents, severe mental illness, pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
Traditional Chinese Medicine Syndrome Score;

Secondary

MeasureTime frame
Cardiac troponin I;Creatine Kinase Isoenzyme;N-terminal pro-brain natriuretic peptide;Left ventricular ejection fraction;Left ventricular end-systolic diameter;left ventricular end diastolic diameter;Mechanism research indicators (IL-1ß, IL-18, TNF-a, TLR4, NF-?B p65, IKKß, NLRP3, caspase-1);

Countries

China

Contacts

Public ContactGuan Jing

Suqian Hospital of Chinese Medicine

guanj15150762651@163.com15150762651

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026