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Effects of Salvianolate Injection on Myocardial Microcirculation in Patients With Acute STEMI After Primary PCI (SISTEMI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03045562
Recruitment Status : Unknown
Verified February 2017 by Green Valley Group of China.
Recruitment status was:  Recruiting
First Posted : February 7, 2017
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
Green Valley Group of China

Brief Summary:
To evaluate the influence of Salvianolate injection on myocardial microcirculation perfusion in subjects with STEMI who underwent primary PCI

Condition or disease Intervention/treatment Phase
STEMI - ST Elevation Myocardial Infarction Drug: Normal saline Drug: Salvianolate injection Phase 4

Detailed Description:
This is a prospective, randomized, double-blind and controlled study.536 subjects of STEMI who underwent primary PCI within the first 12 hours will be enrolled.all patients were assigned to receive 300mg of asprin and ≥300mg of clopidogrel as loading dose,and following 100mg and 75mg once daily respectively.Patients were assigned to receive Salvianolate injection or 0.9% sodium chloride injection in catherter room setting,and following similar medicine once daily respectively for 7 days.Myocardial circulation perfusion will be checked with mmediate coronary angiography parameters,ECG,echocardiographic,CK-MB.The major adverse cardiovascular events will be observed.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 536 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Salvianolate Injection on Myocardial Microcirculation in Patients With Acute ST Segment Elevation Myocardial Infarction After Primary PCI
Actual Study Start Date : January 20, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Placebo Comparator: Control group
Patients will be assigned to receive 100ml of normal saline
Drug: Normal saline
Patients will be assigned to receive 100ml of normal saline in catherter room setting,and following similar medicine once daily for 7 days.
Other Name: 0.9% sodium chloride solution

Experimental: Experimental group
Patients will be assigned to receive Salvianolate injection dissolved in 100ml of normal saline
Drug: Salvianolate injection
Patients will be assigned to receive Salvianolate injection dissolved in 100ml of normal saline in catherter room setting,and following similar medicine once daily for 7 days.
Other Name: Salvianolate




Primary Outcome Measures :
  1. TIMI flow grade [ Time Frame: an average of 2 hours ]
    Use TIMI flow grade to evaluate myocardial circulation perfusion

  2. TIMI myocardial perfusion grade [ Time Frame: an average of 2 hours ]
    Use TIMI myocardial perfusion grade to evaluate myocardial circulation perfusion


Secondary Outcome Measures :
  1. ST-segment resolution [ Time Frame: up to 90 minutes ]
    Use ST-segment resolution to evaluate the epicardial blood flow perfusion

  2. myocardial contrast echocardiograph [ Time Frame: up to 7 days ]
    Use myocardial contrast echocardiograph to evaluate the myocardial microcirculation perfusion

  3. creatine kinase isoenzyme [ Time Frame: up to 48 hours ]
    Use creatine kinase isoenzyme to evaluate myocardial infarct size

  4. major adverse cardiovascular events [ Time Frame: an average of 30 days ]
    all-caused death, re-infarction, target vessel revascularization, stroke



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Informed consent must be obtained prior to any study procedure.
  2. Age>18 years.
  3. Subjects of STEMI who underwent primary PCI within the first 12 hours.

Exclusion Criteria:

  1. Allergic to Salvianolate injection
  2. Mechanical complications
  3. History of severe renal or hepatic insufficiency
  4. Pregnant or breastfeeding women
  5. Pool compliance,greater risks result from the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045562


Contacts
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Contact: Hongying Liu, doctor yuyangxian021@163.com

Locations
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China, Shanghai
Zhongshan Hospital Affiliated to Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Hongying Liu, doctor    +86 21 64041990    yuyangxian021@163.com   
Principal Investigator: Junbo Ge, doctor         
Sponsors and Collaborators
Green Valley Group of China
Investigators
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Study Chair: Junbo Ge, doctor Shanghai Zhongshan Hospital

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Responsible Party: Green Valley Group of China
ClinicalTrials.gov Identifier: NCT03045562    
Other Study ID Numbers: GV-MD-CT201602
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases