the Effect of Danhong Injection on Microcirculation in the Treatment of Patients With STEMI After the PTCA Surgery.
This trial is active, not recruiting.
|Treatments||danhong injection, normal saline|
|Sponsor||Beijing Bozhiyin T&S Co., Ltd.|
|Start date||March 2014|
|End date||December 2015|
|Trial size||180 participants|
|Trial identifier||NCT02158559, DH-140318-01|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
After 7 days surgery used magnetic resonance assessed myocardial perfusion and myocardial function.
time frame: 1 week
Male or female participants from 18 years up to 75 years old.
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.
|Official title||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.|
|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.|
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