Clinical trial on the treatment of coronary microvascular disease with Shexiang Tongxin dropping pill
- Conditions
- coronary microvascular disease
- Registration Number
- ITMCTR2024000027
- Lead Sponsor
- Guangdong provincial Hospital of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1.Men or women aged 35-75
2.Symptoms of myocardial ischemia, including patients with stable angina pectoris and unstable angina pectoris
3.LVEF >50% or more confirmed by transthoracic cardiac ultrasound
4.Perform coronary angiography or coronary CT (MSCT) to determine that there is no >50% stenosis in the three major epicardial vessels, or prior PCI with no >50% stenosis in the original stent
5.Objective evidence of myocardial ischemia, such as ischemic changes on the electrocardiogram during angina episodes or ischemic changes on the electrocardiogram induced by the use of a flat-plate exercise loading test, and/or abnormal ventricular wall motion
6.Impaired coronary microvascular function is suggested by the use of any of the following tests:
a. Intracoronary pressure guidewire to detect the coefficient of microcirculatory resistance (IMR)
b. Selective coronary angiography suggests the phenomenon of slow coronary blood flow (TIMI flow frame count method)
c.Cardiac magnetic resonance imaging (CMR)
7. Voluntarily undergo all examinations and follow-up assessments required by the study protocol
8. Subjects were informed and voluntarily signed an informed consent form
1. new acute myocardial infarction within 3 months
2. Subjects cannot tolerate dual antiplatelet therapy
3. Obvious hematopoietic system abnormalities, such as platelets <72 x 10^9/L or >700 x 10^9/L and white blood cells <3 x 10^9/L
4. Active bleeding and obvious bleeding tendency, such as active ulcers, recent ischemic stroke, history of hemorrhagic stroke, intracranial space-occupying lesions, recent craniocerebral trauma, active bleeding from other organs that cannot be easily hemostatized, or bleeding tendency
5. Combined with other organ failure, such as severe renal insufficiency (GFR<30ml/min/1.73m2) or severe hepatic impairment (AST or ALT elevated more than 3 times the upper limit of normal value), combined with severe congestive heart failure (cardiac function>class III). Suffering from serious diseases with a life expectancy of less than 12 months, such as malignant tumors, other diseases in advanced stages
6. Pregnant women and women planning a pregnancy
7. Acute infectious diseases
8. Combined immune system diseases
9. Subject is allergic to or has contraindications to concomitant medications required by the study protocol (e.g., aspirin, clopidogrel, statins, contrast agents, anticoagulants, nicorandil, muscimol drops, etc.)
10. Patients with cognitive impairment, severe hearing and visual impairment who are unable to complete pre-group communication and who refuse to be reviewed
11. is participating in a clinical trial of another drug or device that has not yet reached its primary endpoint, or is scheduled to participate in a clinical trial of another drug or device within 12 months after surgery
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method coronary angiography blood flow frames;CMR Detection Indicators;
- Secondary Outcome Measures
Name Time Method SF-36 scale;Frequency of angina attacks per week;CCS and visual analog scoring (VAS) to assess the degree of angina symptoms in patients;Indicators of Peripheral and Coronary Blood Sample Testing;Seattle Angina Scale SAQ;Chinese Medicine Points Scale;