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Clinical Trials/ITMCTR2024000027
ITMCTR2024000027
Recruiting
未知

Clinical trial on the treatment of coronary microvascular disease with Shexiang Tongxin dropping pill

Guangdong provincial Hospital of Chinese Medicine0 sitesTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
coronary microvascular disease
Sponsor
Guangdong provincial Hospital of Chinese Medicine
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional study
Sex
All

Investigators

Sponsor
Guangdong provincial Hospital of Chinese Medicine

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Not specified

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