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

Phase 4

• Conditions: Myocardial Infarction
• Interventions: Drug: Danhong Injection; Drug: Normal Saline

• Registration Number: NCT02158559
• Lead Sponsor: Beijing Bozhiyin T&S Co., Ltd.

Brief Summary

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

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 Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-05-29
• Status Verified: 2014-06
• Study First Submitted QC: 2014-06-05
• Last Update Submitted: 2014-06-05
• Study First Posted: 2014-06-09
• Last Update Posted: 2014-06-09
• Primary Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Danhong Injection	Danhong Injection	Danhong injection 40 ml add 250 ml of 0.9% sodium chloride solution, injection intravenous drip, 1 time a day, for 7 days;
Normal Saline	Normal Saline	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;

Primary Outcome Measures

Name	Time	Method
After 7 days surgery used magnetic resonance assessed myocardial perfusion and myocardial function.	1 week