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

Evaluation of the Effect of Shexiang Tongxin Dripping Pills on Coronary Microcirculation in Patients With Acute Anterior Myocardial Infarction by Microcirculation Resistance Index

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Myocardial Infarction
• Intervention / Treatment: Drug: Shexiang Tongxin Dropping Pills + routine treatment; Procedure: routine treatment

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Liyun He; Phone Number: +8613901132937; Email: hly26@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Shexiang Tongxin dripping pills + routine treatment	Drug: Shexiang Tongxin Dropping Pills + routine treatment; oral+percutaneous coronary intervention; Other Names: drugs and surgery
Active Comparator: Control group; routine treatment	Procedure: routine treatment; percutaneous coronary intervention; Other Names: surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IMR	microcirculation resistance index	detected immediately after percutaneous coronary intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial injury markers	cardiac enzymes and troponin T	72 hours

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Study Director: Liyun He, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2021
• Primary Completion (Anticipated): July 31, 2022
• Study Completion (Anticipated): July 31, 2023

Study Registration Dates

• First Submitted: June 27, 2021
• First Submitted That Met QC Criteria: July 4, 2021
• First Posted (Actual): July 7, 2021

Study Record Updates

• Last Update Posted (Actual): July 7, 2021
• Last Update Submitted That Met QC Criteria: July 4, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: M2019480

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No