STEMIPhase 1/2NCT05043558
The Protective Effect of Prostaglandin on Coronary Microcirculation and Ventricular Remodeling After Reperfusion Therapy in Acute ST-segment Elevation Myocardial Infarction
A Phase 1/2 study testing beprostaglandin sodium in people with STEMI, run by Shenzhen People's Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- STEMI
- What is being tested?
- beprostaglandin sodium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 12 Jan 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- (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
Trial locations and contacts
1 site in 1 country.
China1 site
Shenzhen People' S Hospital
Shenzhen, Guangdong, 518000
Huadong Liu, 13724397998
About this study
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.
- Conditions
- STEMI
- Being tested
- beprostaglandin sodium
- Keywords
- Beprostaglandin sodium
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beprostaglandin sodiumDrug
beprostaglandin sodium
| Study group | Role | What they receive |
|---|---|---|
| beprostaglandin sodium | Experimental | Not described Receives: Drug: beprostaglandin sodium |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
ultrasound and CMR to assess the characteristics of myocardial infarction
Q-LAB Scale Scale calculation score
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start1 Jan 2022 (estimated)
- Primary completion10 Jan 2022 (estimated)
- Study completion12 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STEMIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05043558
- Sponsor's protocol ID
- LHD Beraprost sodium
- Status last verified
- Aug 2021
- First submitted
- 25 Aug 2021
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Protective Effect of Prostaglandin on Coronary Microcirculation and Ventricular Remodeling After Reperfusion Therapy in Acute ST-segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT05043558
- Acronym / sponsor ID
- LHD Beraprost sodium
- Conditions
- STEMI
- Keywords
- Beprostaglandin sodium
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Shenzhen People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 10 Jan 2022 (estimated)
- Study completion
- 12 Jan 2022 (estimated)
- First posted
- 14 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| beprostaglandin sodium | Experimental | Drug: beprostaglandin sodium |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| beprostaglandin sodiumbeprostaglandin sodium | Drug | beprostaglandin sodium |
Primary outcome
ultrasound and CMR to assess the characteristics of myocardial infarction
Time frame: 3 years
Q-LAB Scale Scale calculation score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing beprostaglandin sodium in people with STEMI, run by Shenzhen People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huadong Liu, doctor (13724397998, lhd2578@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ultrasound and CMR to assess the characteristics of myocardial infarction (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.