Protective Effect of Beraprost Sodium Tablets on Reperfusion Therapy for Acute STEMI

Essential Hypertension Clinical Trial

Official title:

Protective Effect of Beraprost Sodium Tablets on Coronary Microcirculation Function and Ventricular Remodeling After Reperfusion Therapy for Acute ST Segment Elevation Myocardial Infarction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05103813
• Other study ID #: Beraprost Sodium treat STEMI
• Status: Recruiting
• Phase: Early Phase 1
• Start date: May 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: October 2021
• Source: Shenzhen People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Protective effect of Beraprost Sodium Tablets on coronary microcirculation function and ventricular remodeling after reperfusion therapy for acute ST segment elevation myocardial infarction

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• It meets the diagnostic criteria of acute ST segment elevation myocardial infarction:

ischemic chest pain lasts for more than 30 minutes and can not be relieved by taking nitroglycerin; ST segment elevation of ECG with two or more adjacent leads, limb lead = 1mm, chest lead = 2mm; Or new left bundle branch block; The serum markers of myocardial necrosis increased at least twice the normal value

• Acute myocardial infarction was confirmed by coronary angiography

• The clinical and angiographic data were complete

• Direct PCI was performed within 12 hours after onset

Exclusion Criteria:

• Those who do not cooperate in the inspection, have poor compliance and cannot guarantee the completion of the test

• Conscious disorder, obvious intellectual disorder and mental disorder

• With metal foreign bodies, such as metal prosthesis, intraocular metal foreign bodies, intracranial aneurysm clamp, etc

• People with claustrophobia

• Had a history of myocardial infarction, PCI and coronary artery bypass grafting

• Factors affecting ST segment changes of ECG: complete left bundle branch block, preexcitation syndrome, pacemaker ECG, etc

Related Conditions & MeSH terms

• Essential Hypertension

Intervention

Drug:
• Beraprost Sodium Tablets
Protective effect of Beraprost Sodium Tablets on coronary microcirculation function and ventricular remodeling after reperfusion therapy for acute ST segment elevation myocardial infarction

Locations

Country	Name	City	State
China	Shenzhen People' S Hospital	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiovascular Events	The incidence of mace after 1 week of treatment	1 weeks after baseline
Primary	Major Adverse Cardiovascular Events	The incidence of mace after 6 months of treatment	6 months after baseline
Primary	Major Adverse Cardiovascular Events	The incidence of mace after 1 year of treatment	1 year after baseline