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

Primary Purpose

STEMI - ST Elevation Myocardial Infarction

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Normal saline
Salvianolate injection
Sponsored by
Green Valley Group of China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for STEMI - ST Elevation Myocardial Infarction

Eligibility Criteria

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

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

Sites / Locations

  • Zhongshan Hospital Affiliated to Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control group

Experimental group

Arm Description

Patients will be assigned to receive 100ml of normal saline

Patients will be assigned to receive Salvianolate injection dissolved in 100ml of normal saline

Outcomes

Primary Outcome Measures

TIMI flow grade
Use TIMI flow grade to evaluate myocardial circulation perfusion
TIMI myocardial perfusion grade
Use TIMI myocardial perfusion grade to evaluate myocardial circulation perfusion

Secondary Outcome Measures

ST-segment resolution
Use ST-segment resolution to evaluate the epicardial blood flow perfusion
myocardial contrast echocardiograph
Use myocardial contrast echocardiograph to evaluate the myocardial microcirculation perfusion
creatine kinase isoenzyme
Use creatine kinase isoenzyme to evaluate myocardial infarct size
major adverse cardiovascular events
all-caused death, re-infarction, target vessel revascularization, stroke

Full Information

First Posted
January 20, 2017
Last Updated
February 3, 2017
Sponsor
Green Valley Group of China
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1. Study Identification

Unique Protocol Identification Number
NCT03045562
Brief Title
Effects of Salvianolate Injection on Myocardial Microcirculation in Patients With Acute STEMI After Primary PCI
Acronym
SISTEMI
Official Title
Effects of Salvianolate Injection on Myocardial Microcirculation in Patients With Acute ST Segment Elevation Myocardial Infarction After Primary PCI
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 20, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Green Valley Group of China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
STEMI - ST Elevation Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
536 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Patients will be assigned to receive 100ml of normal saline
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Patients will be assigned to receive Salvianolate injection dissolved in 100ml of normal saline
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
0.9% sodium chloride solution
Intervention Description
Patients will be assigned to receive 100ml of normal saline in catherter room setting,and following similar medicine once daily for 7 days.
Intervention Type
Drug
Intervention Name(s)
Salvianolate injection
Other Intervention Name(s)
Salvianolate
Intervention Description
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.
Primary Outcome Measure Information:
Title
TIMI flow grade
Description
Use TIMI flow grade to evaluate myocardial circulation perfusion
Time Frame
an average of 2 hours
Title
TIMI myocardial perfusion grade
Description
Use TIMI myocardial perfusion grade to evaluate myocardial circulation perfusion
Time Frame
an average of 2 hours
Secondary Outcome Measure Information:
Title
ST-segment resolution
Description
Use ST-segment resolution to evaluate the epicardial blood flow perfusion
Time Frame
up to 90 minutes
Title
myocardial contrast echocardiograph
Description
Use myocardial contrast echocardiograph to evaluate the myocardial microcirculation perfusion
Time Frame
up to 7 days
Title
creatine kinase isoenzyme
Description
Use creatine kinase isoenzyme to evaluate myocardial infarct size
Time Frame
up to 48 hours
Title
major adverse cardiovascular events
Description
all-caused death, re-infarction, target vessel revascularization, stroke
Time Frame
an average of 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Informed consent must be obtained prior to any study procedure. Age>18 years. Subjects of STEMI who underwent primary PCI within the first 12 hours. Exclusion Criteria: Allergic to Salvianolate injection Mechanical complications History of severe renal or hepatic insufficiency Pregnant or breastfeeding women Pool compliance,greater risks result from the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongying Liu, doctor
Email
yuyangxian021@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junbo Ge, doctor
Organizational Affiliation
Shanghai Zhongshan Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Zhongshan Hospital Affiliated to Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongying Liu, doctor
Phone
+86 21 64041990
Email
yuyangxian021@163.com
First Name & Middle Initial & Last Name & Degree
Junbo Ge, doctor

12. IPD Sharing Statement

Learn more about this trial

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

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