- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05043558
The Protective Effect of Prostaglandin on Coronary Microcirculation and Ventricular Remodeling After Reperfusion Therapy in Acute ST-segment Elevation Myocardial Infarction
September 4, 2021 updated by: Shenzhen People's Hospital
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
220
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Huadong Liu, doctor
- Phone Number: 13724397998
- Email: lhd2578@163.com
Study Locations
-
-
Guangdong
-
Shenzhen, Guangdong, China, 518000
- Shenzhen People' S Hospital
-
Contact:
- Huadong Liu
- Phone Number: 13724397998
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 1) Meet the diagnostic criteria for acute ST-segment elevation myocardial infarction: ①The onset of ischemic chest pain lasts for more than 30 minutes and cannot be relieved by taking nitroglycerin; ②The ECG has two or more ST-segment elevations in adjacent leads , Limb leads ≥ 1mm, pectoral leads ≥ 2mm; or newly-appearing left bundle branch block; ③The 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: control group
|
|
Experimental: beprostaglandin sodium
|
beprostaglandin sodium
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ultrasound and CMR to assess the characteristics of myocardial infarction
Time Frame: 3 years
|
Q-LAB Scale Scale calculation score
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 1, 2022
Primary Completion (Anticipated)
January 10, 2022
Study Completion (Anticipated)
January 12, 2022
Study Registration Dates
First Submitted
August 25, 2021
First Submitted That Met QC Criteria
September 4, 2021
First Posted (Actual)
September 14, 2021
Study Record Updates
Last Update Posted (Actual)
September 14, 2021
Last Update Submitted That Met QC Criteria
September 4, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LHD Beraprost sodium
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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