Effects of Salvianolate Injection on Myocardial Microcirculation in Patients With Acute STEMI After Primary PCI
SISTEMI
1 other identifier
interventional
536
1 country
1
Brief Summary
To evaluate the influence of Salvianolate injection on myocardial microcirculation perfusion in subjects with STEMI who underwent primary PCI
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2017
CompletedStudy Start
First participant enrolled
January 20, 2017
CompletedFirst Posted
Study publicly available on registry
February 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedFebruary 7, 2017
February 1, 2017
1.9 years
January 20, 2017
February 3, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
TIMI flow grade
Use TIMI flow grade to evaluate myocardial circulation perfusion
an average of 2 hours
TIMI myocardial perfusion grade
Use TIMI myocardial perfusion grade to evaluate myocardial circulation perfusion
an average of 2 hours
Secondary Outcomes (4)
ST-segment resolution
up to 90 minutes
myocardial contrast echocardiograph
up to 7 days
creatine kinase isoenzyme
up to 48 hours
major adverse cardiovascular events
an average of 30 days
Study Arms (2)
Control group
PLACEBO COMPARATORPatients will be assigned to receive 100ml of normal saline
Experimental group
EXPERIMENTALPatients will be assigned to receive Salvianolate injection dissolved in 100ml of normal saline
Interventions
Patients will be assigned to receive 100ml of normal saline in catherter room setting,and following similar medicine once daily for 7 days.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200032, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Junbo Ge, doctor
Shanghai Zhongshan Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2017
First Posted
February 7, 2017
Study Start
January 20, 2017
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
February 7, 2017
Record last verified: 2017-02