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

February 3, 2017 updated by: Green Valley Group of China

Effects of Salvianolate Injection on Myocardial Microcirculation in Patients With Acute ST Segment Elevation Myocardial Infarction After Primary PCI

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

536

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Zhongshan Hospital Affiliated to Fudan University
        • Principal Investigator:
          • Junbo Ge, Doctor
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Salvianolate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TIMI flow grade
Time Frame: an average of 2 hours
Use TIMI flow grade to evaluate myocardial circulation perfusion
an average of 2 hours
TIMI myocardial perfusion grade
Time Frame: an average of 2 hours
Use TIMI myocardial perfusion grade to evaluate myocardial circulation perfusion
an average of 2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ST-segment resolution
Time Frame: up to 90 minutes
Use ST-segment resolution to evaluate the epicardial blood flow perfusion
up to 90 minutes
myocardial contrast echocardiograph
Time Frame: up to 7 days
Use myocardial contrast echocardiograph to evaluate the myocardial microcirculation perfusion
up to 7 days
creatine kinase isoenzyme
Time Frame: up to 48 hours
Use creatine kinase isoenzyme to evaluate myocardial infarct size
up to 48 hours
major adverse cardiovascular events
Time Frame: an average of 30 days
all-caused death, re-infarction, target vessel revascularization, stroke
an average of 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Green Valley Group of China

Investigators

  • Study Chair: Junbo Ge, doctor, Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2017

Primary Completion (Anticipated)

December 31, 2018

Study Completion (Anticipated)

December 31, 2018

Study Registration Dates

First Submitted

January 20, 2017

First Submitted That Met QC Criteria

February 3, 2017

First Posted (Estimate)

February 7, 2017

Study Record Updates

Last Update Posted (Estimate)

February 7, 2017

Last Update Submitted That Met QC Criteria

February 3, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GV-MD-CT201602

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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