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

STEMI - ST Elevation Myocardial Infarction Clinical Trial

— SISTEMI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03045562
• Other study ID #: GV-MD-CT201602
• Status: Recruiting
• Phase: Phase 4
• First received: January 20, 2017
• Last updated: February 3, 2017
• Start date: January 20, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2017
• Source: Green Valley Group of China
• Contact: Hongying Liu, doctor
• Email: yuyangxian021[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 536
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• STEMI - ST Elevation Myocardial Infarction

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Zhongshan Hospital Affiliated to Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Green Valley Group of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TIMI flow grade	Use TIMI flow grade to evaluate myocardial circulation perfusion	an average of 2 hours
Primary	TIMI myocardial perfusion grade	Use TIMI myocardial perfusion grade to evaluate myocardial circulation perfusion	an average of 2 hours
Secondary	ST-segment resolution	Use ST-segment resolution to evaluate the epicardial blood flow perfusion	up to 90 minutes
Secondary	myocardial contrast echocardiograph	Use myocardial contrast echocardiograph to evaluate the myocardial microcirculation perfusion	up to 7 days
Secondary	creatine kinase isoenzyme	Use creatine kinase isoenzyme to evaluate myocardial infarct size	up to 48 hours
Secondary	major adverse cardiovascular events	all-caused death, re-infarction, target vessel revascularization, stroke	an average of 30 days