the Effect of Danhong Injection on Microcirculation in the Treatment of Patients With STEMI After the PTCA Surgery.

Study Overview
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Brief Summary
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This study focused on the effect of Danhong injection on microcirculation in the treatment of patients with STEMI(ST-elevation myocardical infarction) after the PTCA surgery.

Detailed Description
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Research Topic. A randomized, double-blind, placebo-controlled, multi-center clinical trial of the effect of Danhong Injection on microcirculation in the treatment of patients with STEMI(ST- elevation myocardical infarction) after the PTCA surgery. Research Purpose. This study focused on the effect of Danhong injection on microcirculation in the treatment of patients with STEMI(ST-elevation myocardical infarction) after the PTCA surgery. Research design. A randomized, double-blind, placebo-controlled, multi-center clinical trial.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Multi-center Clinical Trial of the Effect of Danhong Injection on Microcirculation in the Treatment of Patients With STEMI(ST- Elevation Myocardical Infarction) After the PTCA Surgery.

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Drug: Danhong Injection
* Drug: Normal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinically definite or laboratory-supported diagnosis of STEMI ,with the indication of PTCA surgery. 18≤Age≤75; Agreed to join in the study and signed the inform consent form. Exclusion Criteria: Cardiogenic shock , Killip III-IV degree , papillary muscle rupture , septal perforation , episodes of ventricular tachycardia and ventricular fibrillation after electrical cardioversion , temporary pacemaker implanted AVB III degree. Past history of PCI and CABG Acute or chronic infectious diseases(for example severe pneumonia); Recent history of hemorrhagic stroke(within six months) Combined with liver and kidney dysfunction; History of valvular heart disease; Congenital heart disease or Pulmonary hypertension; All kinds of history of cardiomyopathy; Bleeding and other thrombotic diseases; Severe anemia , thrombocytopenia , Other diseases of the blood system; Cancer , Autoimmune disease , All kinds of the patients who use the glucocorticoid and immunosuppressor; Menstrual period women, pregnant women and lactating women, pregnancy test positive or recent family planning.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Danhong Injection<br>Danhong injection 40 ml add 250 ml of 0.9% sodium chloride solution, injection intravenous drip, 1 time a day, for 7 days; | Drug: Danhong Injection<br>* Danhong injection 40 ml add 250 ml of 0.9% sodium chloride solution, injection intravenous drip, 1 time a day, for 7 days;<br>|
| Placebo Comparator: Normal Saline<br>0.9% sodium chloride solution 40 ml add 250 ml of 0.9% sodium chloride solution, injection intravenous drip, 1 time a day, for 7 days; | Drug: Normal Saline<br>* 0.9% sodium chloride solution 40 ml add 250 ml of 0.9% sodium chloride solution, injection intravenous drip, 1 time a day, for 7 days;<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| After 7 days surgery used magnetic resonance assessed myocardial perfusion and myocardial function. |  | 1 week |