Effect of Shexiang Tongxin Dropping Pills on Microcirculation in Patients With AMI
Primary Purpose
Acute Myocardial Infarction
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Shexiang Tongxin Dropping Pills + routine treatment
routine treatment
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Control group
Arm Description
Shexiang Tongxin dripping pills + routine treatment
routine treatment
Outcomes
Primary Outcome Measures
IMR
microcirculation resistance index
Secondary Outcome Measures
Myocardial injury markers
cardiac enzymes and troponin T
Full Information
NCT ID
NCT04952259
First Posted
June 27, 2021
Last Updated
July 4, 2021
Sponsor
Peking University Third Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04952259
Brief Title
Effect of Shexiang Tongxin Dropping Pills on Microcirculation in Patients With AMI
Official Title
Evaluation of the Effect of Shexiang Tongxin Dripping Pills on Coronary Microcirculation in Patients With Acute Anterior Myocardial Infarction by Microcirculation Resistance Index
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2021 (Anticipated)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Shexiang Tongxin dripping pills + routine treatment
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
routine treatment
Intervention Type
Drug
Intervention Name(s)
Shexiang Tongxin Dropping Pills + routine treatment
Other Intervention Name(s)
drugs and surgery
Intervention Description
oral+percutaneous coronary intervention
Intervention Type
Procedure
Intervention Name(s)
routine treatment
Other Intervention Name(s)
surgery
Intervention Description
percutaneous coronary intervention
Primary Outcome Measure Information:
Title
IMR
Description
microcirculation resistance index
Time Frame
detected immediately after percutaneous coronary intervention
Secondary Outcome Measure Information:
Title
Myocardial injury markers
Description
cardiac enzymes and troponin T
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liyun He
Phone
+8613901132937
Email
hly26@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liyun He
Organizational Affiliation
Peking University Third Hospital
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Shexiang Tongxin Dropping Pills on Microcirculation in Patients With AMI
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