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

Primary Purpose

Myocardial Infarction

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Danhong Injection
Normal Saline
Sponsored by
Beijing Bozhiyin T&S Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Danhong Injection

    Normal Saline

    Arm Description

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

    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;

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    May 29, 2014
    Last Updated
    June 5, 2014
    Sponsor
    Beijing Bozhiyin T&S Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02158559
    Brief Title
    the Effect of Danhong Injection on Microcirculation in the Treatment of Patients With STEMI After the PTCA Surgery.
    Acronym
    Danhong
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2014 (undefined)
    Primary Completion Date
    December 2015 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Beijing Bozhiyin T&S Co., Ltd.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myocardial Infarction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    180 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Danhong Injection
    Arm Type
    Experimental
    Arm Description
    Danhong injection 40 ml add 250 ml of 0.9% sodium chloride solution, injection intravenous drip, 1 time a day, for 7 days;
    Arm Title
    Normal Saline
    Arm Type
    Placebo Comparator
    Arm Description
    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;
    Intervention Type
    Drug
    Intervention Name(s)
    Danhong Injection
    Intervention Description
    Danhong injection 40 ml add 250 ml of 0.9% sodium chloride solution, injection intravenous drip, 1 time a day, for 7 days;
    Intervention Type
    Drug
    Intervention Name(s)
    Normal Saline
    Intervention Description
    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 Measure Information:
    Title
    After 7 days surgery used magnetic resonance assessed myocardial perfusion and myocardial function.
    Time Frame
    1 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

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