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

Beijing Bozhiyin T&S Co., Ltd.180 enrolled

Overview

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 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

180

Conditions

Myocardial Infarction

Interventions

Danhong InjectionDRUG

Danhong injection 40 ml add 250 ml of 0.9% sodium chloride solution, injection intravenous drip, 1 time a day, for 7 days;

Normal SalineDRUG

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;

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

After 7 days surgery used magnetic resonance assessed myocardial perfusion and myocardial function.

Time frame: 1 week

Data from ClinicalTrials.gov

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