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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05043558
Other study ID # LHD Beraprost sodium
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date January 1, 2022
Est. completion date January 12, 2022

Study information

Verified date August 2021
Source Shenzhen People's Hospital
Contact Huadong Liu, doctor
Phone 13724397998
Email lhd2578@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To explore the protective effect of prostaglandin sodium on coronary microcirculation function and ventricular remodeling after reperfusion treatment of acute ST-segment elevation myocardial infarction.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 220
Est. completion date January 12, 2022
Est. primary completion date January 10, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - 1) Meet the diagnostic criteria for acute ST-segment elevation myocardial infarction: ?The onset of ischemic chest pain lasts for more than 30 minutes and cannot be relieved by taking nitroglycerin; ?The ECG has two or more ST-segment elevations in adjacent leads , Limb leads = 1mm, pectoral leads = 2mm; or newly-appearing left bundle branch block; ?The increase in serum markers of myocardial necrosis is at least twice the normal value; (2) Coronary angiography confirmed acute myocardial infarction; (3) Direct PCI treatment within 12 hours of onset; (4) Complete clinical and radiographic data. Exclusion Criteria: - (1) Those who do not cooperate in the inspection, have poor compliance, and cannot guarantee the completion of the test; (2) Persons with consciousness impairment, obvious intellectual impairment and mental abnormality; (3) With metal foreign bodies, such as metal prostheses, intraocular metal foreign bodies, intracranial aneurysm clamps, etc.; (4) Those who suffer from closure phobia; (5) Those who have had a history of myocardial infarction, PCI treatment, or coronary artery bypass graft; (6) Factors affecting the changes in the ST segment of the electrocardiogram: complete left bundle branch block, pre-excitation syndrome, pacemaker electrocardiogram

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
beprostaglandin sodium
beprostaglandin sodium

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 ultrasound and CMR to assess the characteristics of myocardial infarction Q-LAB Scale Scale calculation score 3 years
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