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

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ClinicalTrials.gov Identifier: NCT02158559
Recruitment Status : Unknown
Verified June 2014 by Beijing Bozhiyin T&S Co., Ltd..
Recruitment status was:  Active, not recruiting
First Posted : June 9, 2014
Last Update Posted : June 9, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: Danhong Injection Drug: Normal Saline Phase 4

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.
Study Start Date : March 2014
Estimated Primary Completion Date : December 2015

Arm Intervention/treatment
Experimental: 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;
Drug: 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;
Placebo Comparator: 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;
Drug: 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 :
  1. After 7 days surgery used magnetic resonance assessed myocardial perfusion and myocardial function. [ Time Frame: 1 week ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Responsible Party: Beijing Bozhiyin T&S Co., Ltd.
ClinicalTrials.gov Identifier: NCT02158559     History of Changes
Other Study ID Numbers: DH-140318-01
First Posted: June 9, 2014    Key Record Dates
Last Update Posted: June 9, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Pharmaceutical Solutions