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A randomized, double-blind, placebo-controlled study on the improvement of microcirculation dysfunction in patients with NSTE-ACS undergoing elective PCI with Shenyuandan capsules during perioperative period

A randomized, double-blind, placebo-controlled study on the improvement of microcirculation dysfunction in patients with NSTE-ACS undergoing elective PCI with Shenyuandan capsules during perioperative period

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074713
Enrollment
Unknown
Registered
2023-08-14
Start date
2023-08-20
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

Microcirculatory dysfunction during PCI perioperative period

Interventions

trial group:Standardized treatment+SYD
control group:Standardized treatment+SYD simulant capsules

Sponsors

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1) Age range from 18 to 85 years old; 2) Comply with NSTE-ACS diagnostic standards; 3) Agree to undergo coronary angiography; 4) Coronary angiography showed stenosis of the proximal and middle segments of the anterior descending branch exceeding 70% and agreed to receive PCI treatment; 5) Conforming to the diagnostic criteria for Qi deficiency and blood stasis syndrome of traditional Chinese medicine chest obstruction and heartache disease; 6) Voluntarily sign an informed consent form;

Exclusion criteria

Exclusion criteria: 1) Stable angina or acute ST segment elevation myocardial infarction; 2) Patients who require emergency PCI; 3) Patients who require coronary artery bypass grafting; 4) Individuals who are allergic to experimental drugs; 5) Severe cardiac insufficiency (left ventricular ejection fraction3 mg/dl or 265.2 umol/l); 8) Malignant tumors or hematological diseases; 9) Pregnant and lactating patients; 10) Regularly taking medication preparations containing traditional Chinese medicine ingredients in the first month before inclusion; 11) Require taking other traditional Chinese medicine preparations during clinical observation;

Design outcomes

Primary

MeasureTime frame
index of microcirculatory resistance;

Secondary

MeasureTime frame
Cardiac function index;Serum myocardial necrosis markers;Inflammatory damage factor;

Countries

China

Contacts

Public ContactHongxu Liu

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, China

1837058637@qq.com+86 10 8790 7499

Outcome results

None listed

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