Effect of Shexiang Tongxin Dropping Pills on Microcirculation in Patients With AMI

Phase 4

• Conditions: Acute Myocardial Infarction
• Interventions: Drug: Shexiang Tongxin Dropping Pills + routine treatment; Procedure: routine treatment

• Registration Number: NCT04952259
• Lead Sponsor: Peking University Third Hospital

Brief Summary

This study is a randomized, controlled clinical trial. Evaluation of microcirculation resistance by index of microcirculation resistance to explore the protective effect of Shexiang Tongxin dripping pills on microcirculation in patients with acute anterior myocardial infarction.

Detailed Description

Percutaneous coronary intervention (PCI) is the best way to improve the prognosis of patients with acute myocardial infarction (AMI), and ischemia-reperfusion injury (I/R) can damage the vascular endothelium through complex mechanisms, leading to microcirculation dysfunction and aggravation myocardial damage and affect the prognosis. Cell and animal experiments have proved that Shexiang Tongxin Dropping Pill has anti-inflammatory, anti-oxidant, reducing I/R damage, reducing infarct size, improving peripheral muscle microcirculation, and improving coronary slow blood flow, but it lacks directive evidences of improved coronary microcirculation in AMI patients. The microcirculation resistance index (IMR) is a parameter to evaluate the microcirculation state obtained by the pressure/temperature guidewire during PCI, which can accurately and quantitatively reflect the patient's coronary microcirculation state. In this study, patients with acute anterior wall elevation ST-segment myocardial infarction (STEMI) who were prospectively selected for direct PCI treatment were randomly divided into treatment group and control group. The treatment group was given Shexiang Tongxin Dropping Pills before PCI and received direct PCI treatment, the control group only received direct PCI treatment. The IMR of the two groups was detected immediately after PCI, and the differences in IMR values, myocardial injury markers and cardiac function parameters between the two groups were analyzed. It is hoped to prove that Shexiang Tongxin dripping pills have coronary microcirculation protection in acute anterior wall elevation ST-segment myocardial infarction with undergoing direct PCI treatment, and the effect is rapid, so as to provide a basis for optimizing AMI treatment strategies.

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-27
• Study First Submitted QC: 2021-07-04
• Last Update Submitted: 2021-07-04
• Study First Posted: 2021-07-07
• Last Update Posted: 2021-07-07
• Study Start: 2021-08-01
• Primary Completion: 2022-07-31
• Study Completion: 2023-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age ≥ 18 years old, no gender limit;
• Anterior wall STEMI within 12 hours of onset (diagnostic criteria: ischemic chest pain lasting ≥30min; ST-segment elevation or new left bundle branch block in two or more adjacent leads on the ECG; with or without Elevated myocardial markers), emergency PCI treatment is planned;
• Infarct-related coronary vascular anatomy is suitable for PCI treatment;
• Agree and cooperate to participate in this research, and sign an informed consent form

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Exclusion Criteria

• Past history of myocardial infarction history;
• The arteries related to infarction have received PCI in the past;
• Past CABG history;
• Killip grade of cardiac function ≥ grade III or cardiogenic shock;
• Systolic blood pressure ≤90mmHg;
• Bradycardia, heart rate <60 beats/min, or atrioventricular block of degree II or more;
• Allergic to Shexiang Tongxin Dropping Pills
• Past history of asthma or severe COPD;
• Severe liver and kidney dysfunction;
• Participate in other clinical trials within 3 months;
• Pregnancy or breastfeeding.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Shexiang Tongxin Dropping Pills + routine treatment	Shexiang Tongxin dripping pills + routine treatment
Control group	routine treatment	routine treatment

Primary Outcome Measures

Name	Time	Method
IMR	detected immediately after percutaneous coronary intervention	microcirculation resistance index

Secondary Outcome Measures

Name	Time	Method
Myocardial injury markers	72 hours	cardiac enzymes and troponin T